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Skin Regeneration: The Science and How to Boost It – Healthline

By daniellenierenberg

The body is always in a state of change. In particular, the cells in your skin are constantly replacing themselves.

The skin does this through the process of regeneration and repair.

On a cellular level, the skin cells are constantly shedding, revealing fresh, newly grown skin cells underneath. This is why scars and blemishes may fade a bit with time.

Understanding the science behind your skins life cycle can help you to take care of your skin as it goes through the regeneration process. It can also help you boost your skins natural regeneration process and give you a fresh glow.

Heres what the skin care experts have to say about how to speed up skin regeneration.

According to 2015 research, skin regeneration refers to the complete replacement of damaged tissue with new tissue. Skin repair refers to the continued healing process of existing tissue. Skin regeneration isnt usually associated with scar tissue.

The research goes on to say that skin regeneration can happen in two ways:

Skin regeneration is a natural physical process that occurs on a cellular level.

The epidermis cells, or top layers of skin, continuously replace themselves, explains Laura Chacon-Garbato, a licensed esthetician and director of education at Herbalife. This process of renewal is the process of shedding the epidermis.

In other words, skin regeneration is a constant renewal of cells.

According to a 2010 review, the epidermis is maintained by stem cells in the lowest layer of the skin. These epidermal stem cells generate daughter cells that move upward toward the surface of the skin.

During this journey, cells that produce keratin undergo a series of biochemical and morphological changes that result in the formation of the various layers of the skin.

This gives skin a young, healthy glow, adds Jennifer Hurtikant, chief science officer at Prime Matter Labs.

The same study mentioned above estimated that the epidermis turns over every 40 to 56 days on average.

When were young, the process of exfoliation happens naturally, but as we age this process is altered and slows down, Chacon-Garbato says.

An older 2006 study notes that the usual 28-day turnover time for skin increases approximately 30 percent to 50 percent by age 80.

For people over 50 years old, Chacon-Garbato says, the process can take as long as 84 days.

The effects of the slowdown cause buildup and an excess of dead skin cells that can make the skin look tired, dull, and opaque, she says.

Throughout this process, several things occur on a cellular level.

First, new skin cells are formed deep in the epidermis.

Then, as the skin cells mature and die on the upper layer of the epidermis, they naturally fall away.

If you have a cut or burn, you may be left with a scar.

This is because fibroblasts in scar tissue form collagen differently than in regular tissue. As a result, its thicker and less flexible than regular skin tissue.

However, by improving skin regeneration, you may notice that scars gradually fade away as fresh, healthy skin tissue forms beneath them.

As you get older, skin regeneration slows down. This leaves an accumulation of dead skin cells on the upper layer of the skin.

By boosting the natural regeneration process, you can help the skin look fresh and feel elastic, even as you age.

Making healthy choices can help to keep the skin regeneration process functioning optimally.

Hurtikant suggests:

There are two types of aging, cellular or intrinsic aging and environmental or extrinsic aging.

Intrinsic aging is a genetically predetermined process that occurs naturally, but may increase with stress. Extrinsic aging is a result of outside factors, like where you live and your lifestyle habits.

Stress causes intrinsic aging and the environment causes extrinsic aging, Hurtikant says.

Chacon-Garbato recommends eating plenty of protein, such as:

Proteins are essential for tissue repair and the construction of new tissue, she says. Cells need protein to maintain their life, so the body uses protein to replace worn-out or dead skin cells.

In addition, favor foods that are high in antioxidants, like:

Including antioxidants in your diet may help improve the glow and luster of the skin.

Specific skin care products can also help improve the natural cell turnover process, hydrate the skin, and get rid of built-up dead skin cells. Look for ingredients like:

Use products with vitamin B3, Chacon-Garbato suggests. Its a necessary component of cell metabolism, also known as niacinamide, and is required for many skin processes that help maintain healthy-looking skin.

She also suggests using antioxidants such as vitamin C and E to prevent cellular damage from free radicals.

Try Swisse Beauty Skin Regeneration+, an oral supplement with ALA, and Musely FaceRx Anti-Aging Night Cream with tretinoin, hyaluronic acid, and niacinamide.

These natural remedies may help boost your skins health and promote the skin regeneration process:

A 2022 study found that several plant extracts, including papaya, showed antioxidant, and antiwrinkle effects. Extracts that used ethanol as a cosolvent showed greater effects.

A 2018 review found that jojoba, rosehip, and coconut oil may help with skin barrier repair, wound healing, antioxidant effects, and antiaging.

A 2010 study noted that orange peel extract could provide useful protection against or alleviation of UV damage.

You can look for natural skin care products that contain these ingredients.

Citrus can increase photosensitivity, or sensitivity to light. Use caution when applying citrus in any form to the skin by avoiding direct sun exposure and using sun protection. Never apply citrus oils directly to the skin.

If you want to exfoliate a little deeper, a dermatologist may be able to offer a more intensive skin resurfacing procedure to kick-start skin rejuvenation. Make sure you find a dermatologist who is board certified.

Chacon-Garbato suggests:

However, she notes, theres no one-size-fits-all for the skin, so its important to check with your dermatologist to help define the best approach for the results you want to achieve.

Want to know more? Get the FAQs below.

Aloe vera encourages cell diversity and helps keep the skin well hydrated and protected.

According to a 2020 study, it also boasts natural antioxidant and anti-inflammatory properties.

Aloe vera is an excellent ingredient to use daily because its well known for its revitalizing and calming properties, Chacon-Garbato says. Its also a hugely effective hydrator and helps to minimize skin dryness.

She notes that its been used for centuries for beauty because of its many benefits, including delivering moisture directly to the tissue and helping prevent water loss due to evaporation.

Hurtikant adds that while aloe vera is great for boosting regeneration, there are other ingredients to try too.

Trending ingredients for skin regeneration are derivatives of algae and mushrooms, and hyaluronic acid, she says.

There are plenty of skin care products that have been shown to improve the appearance of aging in the skin by speeding up the natural skin regeneration process.

One highly rated product is Musely FaceRx Anti-Aging Night Cream, which includes active ingredients such as tretinoin (Retin-A), niacinamide, and hyaluronic acid.

These three ingredients are all excellent for encouraging exfoliation. Keep an eye out for them on the ingredients list when youre looking for good creams to promote regeneration.

For most adults under 50 years old, the cycle lasts between 28 and 42 days. For adults over 50 years old, this may increase to up to 84 days, though the number varies.

The time it takes for your skin to complete the skin regeneration cycle depends on a range of factors, including:

There are a range of ways to improve skin regeneration.

Simple lifestyle changes like exercise and increased hydration can keep the process working properly.

Skin creams that include exfoliating ingredients can also help to get rid of excess dead skin.

Some procedures can also encourage faster growth of new skin cells to speed up the regeneration process.

Aging slows down the skin regeneration process, but it doesnt ever stop it completely.

However, because the process becomes much slower as we age, the skin can appear thicker, less flexible, and more wrinkled or textured.

This is because the slower the regeneration, the more dead skin cells remain on the face.

Skin regeneration is a natural cycle that occurs as the skin cells turn over. In other words, dead skin cells on the top layer of the epidermis fall away, revealing fresh, newly created cells beneath.

By supporting this cycle with a healthy lifestyle and skin care routine, you can encourage a lustrous glow even as you get older.

Just remember: while boosting skin regeneration is possible, its natural for the cycle to slow down as you age. A few wrinkles and some texture are nothing to be ashamed of.

You can even think of them as signs of wisdom and experience.

Meg is a freelance journalist and features writer who covers culture, entertainment, lifestyle and health. Her writing has appeared in Cosmopolitan, Shondaland, Healthline, HelloGiggles, Readers Digest, Apartment Therapy, and more. T: @wordsbyMeg W: megwalters.co.uk

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Skin Regeneration: The Science and How to Boost It - Healthline

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Revolutionary Jab that Could Repair Spinal Cord Injuries Developed by Scientists – Good News Network

By daniellenierenberg

The green colors are increased synapses resulting from a regeneration in nerve axons SWNS

A revolutionary treatment that could repair spinal cord injuries has been developed by scientists which regrew nerves in paralyzed mice within three months.

The medication triggers cells of long spindly parts of the severed nerves called axons to regenerative themselves.

Currently, spinal cord injury does not have any effective treatments that involves a repairing of what was damaged. Physical rehabilitation can help patients regain some mobility, and a number of electrical stimulation technologies can stimulate nerves and muscles to act as before, but never with the precision of the real thing.

This work shows a drug called TTK21 that is administered systemically once a week after a chronic spinal cord injury in animals can promote neuronal regrowth and an increase in synapses that are needed for neuronal transmission, said lead author Dr. Simone Di Giovanni, of Imperial College London.

This is important because chronic spinal cord injury is a condition without a cure where neuronal regrowth and repair fail.

Damage to the spinal cord interrupts the constant stream of electrical signals from the brain to the body. It can lead to paralysis below an injury.

The study published in the journal PLOS Biology showed TTK21 aided the regrowth of sensory and motor neurons when given to mice 12 weeks after severe injury.

It belongs to a group of therapies known as epigenetic activators which target damaged DNA.

In experiments, lab rodents with severe spinal cord injury lived in an enriched environment with opportunities to be physically activeas is encouraged in human patients.

Treatment lasted for 10 weeks. Several improvements were identified, the most noticeable being the sprouting of more axons in the spinal cord. Retraction of motor axons above the point of injury was also halted, and sensory axon growth increased.

SIMILAR: Movement in Paralyzed Arms is Restored by Zapping Spinal Cords With Electrical Stimulation

The next step will be to boost the effects even more and get regenerating axons to reconnect to the rest of the nervous system so animals can regain their ability to move with ease.

We are now exploring the combination of this drug with strategies that bridge the spinal cord gap such as biomaterials as possible avenues to improve disability in SCI patients, said Di Giovanni.

For decades, this has remained a major challenge. Our bodys central nervous system, which includes the brain and spinal cord, does not have any significant capacity to repair itself.

RELATED: First Time Someone With Cut Spinal Cord is Able to Walk Freely, Thanks to New Swiss Technology

In the U.S., an estimated 300,000 people and another 50,000 in the UK are living with a spinal cord injury.

Last year GNN reported that Yale had used stem cells to repair patients injured spinal cords, which could be another future avenue to repairing nerves and axons.

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Revolutionary Jab that Could Repair Spinal Cord Injuries Developed by Scientists - Good News Network

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WIN: A beauty box of dreams valued at R3000 – CapeTown ETC

By daniellenierenberg

WIN: A beauty box of dreams valued at R3000

Winters whispers are quickly reaching a crescendo, and that means giving your skin and glam routine a big, warm hug. Finding what products work for you can be a painstaking and expensive task. So, weve put together a fabulous Beauty Box full of goodies just for you.

With the help of expert local beauty Editor, Jade Smith, the Beauty Box has been curated with nothing short of the best products. It contains nine items that, together, are valued at R3 000.

Jade Smith is the beauty brain behind some of South Africas most adored magazines, including Woman&Home, and has over 20 years of experience in the industry. She started her career as a make-up artist and has worked on many international campaigns in London and Europe, including work for iconic brands like Tom Ford and Dove. Every product is personally tried and tested and selected by Jade and only the best makes it into the box.

In sharing a little warmth this winter, Cape {town} Etc is giving away three Beauty Boxes to three lucky winners. Get ready to glow all season long.

1. Afari Overnight Regenerating Cream 50ml

A luxurious overnight skin-repairing cream loaded with potent ingredients to help skin look renewed by morning. It helps to boost natural collagen production and speed up cell turnover for bouncier, smoother skin.

This brand is proudly South African, free from nasties, and cruelty-free.

Explore more onwww.afari.co.zaor@afariskincare

2. SKOON Happy Flora Face Moisturiser 15ml

Join the good bacteria movement and re-balance your skins microbiome. Made with Swiss yoghurt and Quora Noni an active ingredient derived from plant stem cells that help to control bacteria.

This brand is proudly South African, free from nasties, and cruelty-free.

Explore more onwww.skoonskin.comor@skoonskin

3. Gatineau Defi Lift 3D Firming Neck & Dcollet Gel 15ml

A gel formula formulated to help tighten skin and visibly firm the delicate neck and dcollet area thanks to Plant Proteins, encapsulated Hyaluronic Acid and Fixlift technology.

Tip: Use gentle, upward strokes all the way up to the jawline using your hands or your favourite stone roller.

Explore more onwww.gatineau.comor@gatineau_sa

4. Rimmel WonderLuxe Volume Mascara in Black

This mascara promises to give lashes full-bodied volume without looking clumpy or weighing lashes down. It also includes Argan, Maracuja, Marula and Calmellia oils to nourish and protect lashes.

Ophthalmologist tested it, which means its safe for contact lens wearers too.

Explore more onwww.rimmellondon.com/en-zaor@rimmellondonsa

5. Berdoues Azur Riviera 10ml

It can be tricky to find your signature scent, which is why its best to test it first. This one is fresh and clean, perfect for both you and your partner, with marine and aquatic notes softened with Orange Blossom and Jasmine at the heart.

Explore more onwww.berdoues.comor@berdouesgrandscrussa

6. BIODERMA Photoderm AKN Mat Sunscreen Cream SPF 30

A mattifying sun protection fluid thats lighter than air and ideal for all skin types. Furthermore, it helps to prevent the appearance of blemishes while protecting against cellular damage, shielding against UVA and UVB, and free radicals.

Explore more onwww.bioderma.co.zaor@biodermasouthafrica

7. Litchi & Titch Mini Aromatherapy Serum

Made with essential oils and botanical extracts of the highest quality, this blend is made with calmness and serenity in mind. Neroli, Grapefruit and Chamomile are heroed, and the formula is suitable for all skin types.

Tip: Apply 5 to 7 drops of the serum and press onto the skin after misting or dampening skin slightly, then cup your hands over your nose and breathe in to set a calming mood.

This brand is proudly South African, free from nasties, and cruelty-free.

Explore more onwww.litchiandtitchnaturals.comor@litchiandtitchnaturals

8. NUXE rve de miel Face & Body Gel 100ml

An ultra-rich cleansing gel using natural active ingredients such as honey, coconut and sunflower. The formula is gentle, yet effective enough to be used on your face and body, and is especially suitable for dry and sensitive skin.

Tip: Thanks to the deliciously rich and creamy texture, it works wonderfully for shaving.

Explore more onwww.nuxe.comor@nuxe_sa

9. Skin Republic Wrinkle Smooth Complex Sheet Mask

A biodegradable sheet mask packed with Adenosine, Green Tea and Plant Stem Cells was chosen for their skin-firming and texture-smoothing powers.

Explore more onwww.theskinrepublic.co.zaor@skinrepublic

To enter, fill in your details and answer the question below:

*Winners will be announced Monday 15 May 2022.

*Hint: All entrants can expect some exciting news on Monday 15 May 2022.

Question: Which item in the Beauty Box are you most excited to try?

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WIN: A beauty box of dreams valued at R3000 - CapeTown ETC

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MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application f – PharmiWeb.com

By daniellenierenberg

DGAP-News: MorphoSys AG / Key word(s): Miscellaneous05.01.2021 / 08:00 The issuer is solely responsible for the content of this announcement.

Media Release

MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application for Tafasitamab

- The Swissmedic MAA seeks approval for tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

PLANEGG/MUNICH, Germany and MORGES, Switzerland - January 5, 2021 - MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted the marketing authorization application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. The MAA seeks approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The MAA will now enter the formal review process by Swissmedic.

The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food and Drug Administration's (FDA) modified Project Orbis, which provides a framework for concurrent submission and review of oncology drug applications among the FDA's international collaborators. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries.

"Currently about 40% of DLBCL patients do not respond to initial therapy or relapse thereafter leading to a high medical need for new, effective therapies," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review by Swissmedic is a pivotal step towards bringing tafasitamab in combination with lenalidomide to eligible patients in Switzerland."

"Tafasitamab in combination with lenalidomide may represent an important new targeted treatment option for patients with relapsed or refractory DLBCL," said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development, MorphoSys. "We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients with a high unmet medical need."

The Swissmedic application, submitted by Incyte in collaboration with MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL and data from the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. If approved, Incyte will hold the marketing authorization, and have exclusive commercialization rights for tafasitamab in Switzerland.

Incyte has exclusive commercialization rights for tafasitamab outside the United States.

About Diffuse Large B-cell Lymphoma (DLBCL)DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide[1], characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter[2]. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL[3],[4],[5].

About L-MINDThe L-MIND trial is a single arm, open-label, multicenter Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study's primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085

About RE-MINDRE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and the EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

About TafasitamabTafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

XmAb(R) is a registered trademark of Xencor, Inc.

About MorphoSysMorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya(R), developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at http://www.morphosys.com or http://www.morphosys-us.com.

Monjuvi(R) is a registered trademark of MorphoSys AG.

Tremfya(R) is a registered trademark of Janssen Biotech, Inc.

About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

MorphoSys Forward-looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Incyte Forward-looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when tafasitamab might be approved in Switzerland for the treatment of, and whether or when tafasitamab might provide a successful treatment option for, in combination with lenalidomide, certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and the L-MIND and RE-MIND clinical trial programs. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by European regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements. # # #

Contacts:

References[1] Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.[2] Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.[3] DRG Epidemiology data.[4] Kantar Market Research (TPP testing 2018).[5] Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

05.01.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at http://www.dgap.de

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MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application f - PharmiWeb.com

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Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine – BioSpace

By daniellenierenberg

MELBOURNE, Australia and BAAR, Switzerland, Nov. 29, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces it has entered into an agreement with Scintec Diagnostics GmbH (Scintec) to acquire TheraPharm GmbH (TheraPharm), a Swiss-German biotechnology company developing innovative diagnostic and therapeutic solutions in the field of hematology.

The acquisition of TheraPharm provides Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in relation to the use of Molecularly Targeted Radiation (MTR) in hematology and immunology. TheraPharm is developing antibody MTR technology against CD66, a cell surface target highly expressed by neutrophils (a type of white blood cell) and tumor-infiltrating lymphocytes. As such, the technology has potentially very broad applications in the diagnosis and treatment of hematologic diseases (e.g. blood cancers), lymphoproliferative disorders and immune-mediated diseases (e.g. lupus, and multiple sclerosis). Of particular interest is the demonstrated use of the technology to safely and effectively perform bone marrow conditioning (BMC) prior to bone marrow stem cell transplant.

Telix CEO, Dr. Christian Behrenbruch stated, Telix is committed to extending and improving the lives of patients with serious diseases. As such, the acquisition of TheraPharm and its MTR assets are uniquely aligned to Telixs mission and technical strengths in antibody engineering and radiochemistry. TheraPharms technology has a significant role to play in BMC and stem cell transplantation across a broad range of blood cancers and rare diseases. The current approach to BMC employs highly toxic drugs that have a poor morbidity and mortality profile, and for which many patients are ineligible. MTR offers an excellent safety profile that may greatly expand the number of patients able to undergo life prolonging stem cell transplantation while greatly reducing the hospitalisation burden and cost associated with such procedures.

TheraPharm co-founder and Managing Director, Dr. Klaus Bosslet added, Over the past 5 years, TheraPharm, in collaboration with Dr. Kim Orchard from the University of Southampton (UK), has made excellent progress developing 90Y-besilesomab for the treatment of hematologic cancers and several related conditions including multiple myeloma, leukemia and amyloidosis. This unique asset is a logical addition to Telixs portfolio, offering a potentially rapid development path to a first commercial indication for the treatment of patients with SALA, while at the same time having potentially broad applications for stem cell transplantation in patients with more common cancers of the blood, including multiple myeloma and leukemia. We look forward to joining the Telix team in order to expedite the development of products for this under-served field.

Full transaction details, including financial terms, can be found via the Telix website and ASX portal here.

About Hematopoietic Stem Cell Transplant (HSCT)

Bone marrow conditioning (BMC) followed by hematopoietic stem cell transplantation (HSCT) is presently performed to treat patients with hematologic malignancies (blood cancers), with the objective of extending patient survival or achieving cure. HSCT is also performed for a broad range of non-cancer conditions. HSCT is preferentially performed in countries of high income (Europe >30,000, Americas >20,000, worldwide >65,000 p.a., respectively) and is growing at around 5% annually.

About Systemic Amyloid Light-Chain Amyloidosis (SALA)

SALA is a rare, but serious protein deposition disease, caused by a protein known as amyloid that is produced by abnormal plasma cells residing in the bone marrow. As amyloid accumulates in the organs of the body, organ function will eventually deteriorate, ultimately causing organ failure. SALA has an estimated prevalence of 30,000 and 45,000 in United States and Europe, respectively and while a rare disease, SALA portends a very poor prognosis, with a median survival from diagnosis of ~11 months if untreated.

The current standard of care comprises of induction therapy (typically cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC, followed by HSCT. This approach is typically only accessible to a small proportion of patients (<20%) who are able to tolerate induction therapy and melphalan BMC.

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit http://www.telixpharma.com.

AboutTheraPharm GmbH

TheraPharm is a biotechnology company specialised in the research, development and manufacturing of monoclonal antibodies for targeted radiation of hematopoietic malignant and non-malignant diseases, lymphoproliferative diseases, conditioning for allogeneic stem cells as well as in diagnostics of inflammatory diseases and bone marrow metastases.

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Impact of COVID 19 on Orthopedic Regenerative Medicine Market Detailed Research Study 2020-2027 | Curasan, Inc., Carmell Therapeutics Corporation,…

By daniellenierenberg

Orthopedic Regenerative Medicine Market

Coherent Market Insights, 26-11-2020: The research report on the Orthopedic Regenerative Medicine Market is a deep analysis of the market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. Experts have studied the historical data and compared it with the changing market situations. The report covers all the necessary information required by new entrants as well as the existing players to gain deeper insight.

Furthermore, the statistical survey in the report focuses on product specifications, costs, production capacities, marketing channels, and market players. Upstream raw materials, downstream demand analysis, and a list of end-user industries have been studied systematically, along with the suppliers in this market. The product flow and distribution channel have also been presented in this research report.

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The segments and sub-section of Orthopedic Regenerative Medicine market are shown below:

By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

Some of the key players/Manufacturers involved in the Orthopedic Regenerative Medicine Market are Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

If opting for the Global version of Orthopedic Regenerative Medicine Market analysis is provided for major regions as follows:

North America (The US, Canada, and Mexico)

Europe (the UK, Germany, France, and Rest of Europe)

Asia Pacific (China, India, and Rest of Asia Pacific)

Latin America (Brazil and Rest of Latin America)

Middle East & Africa (Saudi Arabia, the UAE, South Africa, and Rest of Middle East & Africa)

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The Orthopedic Regenerative Medicine Market Report Consists of the Following Points:

The report consists of an overall prospect of the market that helps gain significant insights about the global market.

The market has been categorized based on types, applications, and regions. For an in-depth analysis and better understanding of the market, the key segments have been further categorized into sub-segments.

The factors responsible for the growth of the market have been mentioned. This data has been gathered from primary and secondary sources by industry professionals. This provides an in-depth understanding of key segments and their future prospects.

The report analyses the latest developments and the profiles of the leading competitors in the market.

The Orthopedic Regenerative Medicine Market research report offers an eight-year forecast.

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Novartis bags Mesoblast’s stem cell therapy for ARDS, including in Covid-19, in a deal worth up to $1.2B+ – Endpoints News

By daniellenierenberg

Novartis has licensed a new stem cell therapy from Mesoblast, just weeks after the FDA rejected the Australian biotechs pitch for an approval on a separate indication.

The Swiss pharma announced Thursday afternoon it is partnering with Mesoblast $MESO to develop remestemcel-L for the treatment of acute respiratory distress syndrome, including ARDS related to Covid-19. As part of the deal, Novartis will shell out $25 million in upfront cash and take a $25 million stake in the biotech, while offering up to $1.255 billion in potential milestone payments.

Mesoblast investors embraced the news, sending shares up 11% on the Australian stock exchange Friday. The companys stock was also up roughly 17% on the Nasdaq before Fridays opening bell.

The milestone payments are split as such, per Mesoblast: $505 million will be available pre-commercialization, with an additional $750 million set aside for hitting certain sales targets and double-digit royalties.

Remestemcel-L, or Ryoncil, acts as an anti-inflammatory and consists of culture-expanded mesenchymal stem cells derived from a bone marrow donor. Currently, the drug is being evaluated in a Phase III study for Covid-19-related ARDS with 300 patients, and the first cut of data is expected in early 2021.

Should that outcome prove successful, Novartis will launch a Phase III in non-Covid ARDS after the deal closes. The companies highlighted Novartis ability to rapidly scale up cell-based therapies from the clinic to the commercial phase as a motivator for the collaboration.

The drug had been examined in a small compassionate use program for Covid-19 ARDS back in March, which included 12 patients requiring ventilators. Remestemcel-L treatment demonstrated an 83% survival rate in that program and was the basis for the ongoing Phase III.

Thursdays deal comes less than two months after the FDA issued a CRL for remestemcel-L in Mesoblasts pediatric acute graft-versus-host disease program. The rejection, which denied the company an accelerated approval, came after an ODAC adcomm in August voted 9 to 1 in favor of approval as panel members struggled to envision what a pivotal trial might look like.

During both the adcomm and in their CRL, regulators took issue with Mesoblasts study design given that the company submitted its application on the basis of one, single-arm and open-label trial. In the study, Remestemcel-L demonstrated a statistically significant benefit in its primary endpoint against the historical control rate.

But because many parents and pediatricians are reluctant to risk putting children into the placebo arm of a randomized study, Mesoblast argued that key opinion leaders said an additional study was not feasible. The veto came despite the FDA approving a similar drug Incyte and Novartis Jakafi based on one single-arm trial, something for which ODAC members chastised the FDA.

Earlier this week, Mesoblast met with the agency for its Type A meeting, and the company reported in its third quarter earnings that it does not expect the FDA to reverse its decision for accelerated approval. Mesoblast is still waiting to receive final meeting minutes to know whether thats indeed the case. The CRL set back potential approval in GvHD from 2021 to 2024, per analysts.

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Mibelle Biochemistry’s Ability to Introduce Breakthrough Active Ingredients for the Personal Care Market Lauded by Frost & Sullivan – PR Newswire…

By daniellenierenberg

The company's active ingredient product lines meet consumer expectations of quality, performance, and sustainability

LONDON, Nov. 18, 2020 /PRNewswire/ --Based on its recent analysis of the global personal care active ingredientsmarket, Frost & Sullivan recognizes Mibelle AG Biochemistry with the 2020 Global Company of the Year Award. It has successfully introduced several breakthrough sustainable active ingredients, whose efficacy is shttps://mma.prnewswire.com/media/1337466/Mibelle_Award.jpg upported by in-vivo and in-vitro study results. Mibelle is a pioneer with regards to using senolytics to delay skin aging in cosmetic applications, which has helped the company achieve a leading positioning in the market.

Photo - https://mma.prnewswire.com/media/1337466/Mibelle_Award.jpg

Click here to view the full multimedia release: https://best-practices.frost.com/mibelle-biochemistry/

"Demonstrating its expertise in recognizing the dynamic needs of the cosmetics industry, Mibelle launched the Alpine Rose Active line of products to fight skin aging,"said Prateeksha Kaul Research Analyst. "This line of products uses a natural senolytic agent extracted from the Alpine rose leaves in the Swiss Alps to eliminate senescent cells, which are the cells responsible for aging, without affecting the neighboring cells. This halts the skin's aging process while rejuvenating it and increasing its elasticity. This product also meets the rising demand for natural and sustainable products over harsh chemicals that are harmful to both the environment and the skin."

Similarly, in response to the growing interest in phytocannabinods, Mibelle introduced an encapsulated cannabidiol (CBD) product, the Lipobelle Pino C. Other players in the market have had limited success with CBD in spite of its potential benefits for the skin because it is not soluble in water. Mibelle addressed this limitation with the Lipobelle Pino C. By encapsulating the CBD into a nanoemulsion using hemp oil, Mibelle made it water-soluble and stable in cosmetic formulations. Its combination with an extract from Swiss stone pines also helps the product fight inflammation. Lipobelle Pino C exploits the anti-inflammatory and regenerating effects of CBD for cosmetic benefits such as easing facial tension, reducing inflammation, and regenerating tissue.

Mibelle has been a pioneer in utilizing interesting biochemical concepts for its active ingredients. In 2008, it gained a first-mover advantage with the launch of its active ingredient PhytoCellTec Malus Domestica, which involved the application of stem cells in cosmetics for the very first time. In 2019, Mibelle utilized its PhytoCellTec technology to launch the PhytoCellTec Goji, which stimulates the mesenchymal stem cell (MSC) culture with goji stem cells for enhancing face shape by preventing the skin from sagging. The success of this technology and other recent innovations has allowed the company to achieve a 15 percent growth rate annually.

"Mibelle works closely with certification bodies to analyze the ingredients, raw materials, and processes to obtain the required certifications for its products. It also collaborates with personal care product manufacturers to offer premium high-quality products that benefit the end user," noted Kaul. "With its ability to introduce breakthrough active ingredients, Mibelle AG Biochemistry has carved a niche for itself in the personal care industry. It has consistently adopted a holistic innovation approach that has enabled it to consistently develop novel concepts and ingredients."

Each year, Frost & Sullivan presents a Company of the Year award to the organization that demonstrates excellence in terms of growth strategy and implementation in its field. The award recognizes a high degree of innovation with products and technologies, and the resulting leadership in terms of customer value and market penetration.

Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

About Frost & Sullivan

For over five decades, Frost & Sullivan has become world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion.

Contact:

Harley GadomskiP: 12104778469E: [emailprotected]

About Mibelle AG Biochemistry

Mibelle Biochemistry designs and develops innovative, high-quality actives based on naturally derived compounds and profound scientific know-how. Inspired by nature - Realized by Science.

For more information on Mibelle Biochemistry, please visit http://www.mibellebiochemistry.com

Contact:

Esther Belser Mibelle Biochemistry, SwitzerlandHead of MarketingPhone: +41 62 836 13 47Email: [emailprotected]

http://www.frost.com

SOURCE Frost & Sullivan

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Mibelle Biochemistry's Ability to Introduce Breakthrough Active Ingredients for the Personal Care Market Lauded by Frost & Sullivan - PR Newswire...

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Mibelle Biochemistry announces: Mibelle Biochemistrys Ability to Introduce Breakthrough Active Ingredients for the Personal Care Market by Frost and…

By daniellenierenberg

18-Nov-2020

Ingredients | Marketing

The company's active ingredient product lines meet consumer expectations of quality, performance andsustainability

Based on its recent analysis of the global personal care active ingredients market, Frost & Sullivan recognises Mibelle AG Biochemistry with the 2020 Global Company of the Year Award.

It has successfully introduced several breakthrough sustainable active ingredients, whose efficacy is supported by in-vivo and in-vitro study results. Mibelle Biochemistry is a pioneer with regards to using senolytics to delay skin aging in cosmetic applications, which has helped the company achieve a leading positioning in the market.

"Demonstrating its expertise in recognising the dynamic needs of the cosmetics industry, Mibelle Biochemistry launched the Alpine Rose Active ingredient to fight skin aging," said Prateeksha Kaul Research Analyst.

"This ingredient contains a natural senolytic agent extracted from the Alpine rose leaves in the Swiss Alps to eliminate senescent cells, which are the cells responsible for ageing, without affecting the neighboring cells.

"This halts the skins aging process while rejuvenating it and increasing its elasticity. This active also meets the rising demand fornatural and sustainable products over harsh chemicals that are harmful to both the environment and the skin."

Similarly, in response to the growing interest in phytocannabinods, Mibelle Biochemistry introduced an encapsulated cannabidiol (CBD) ingredient, the Lipobelle Pino C. Other players in the market have had limited success with CBD in spite of its potential benefits for the skin because it is not soluble in water.

Mibelle addressed this limitation with the Lipobelle Pino C. By encapsulating the CBD into a nanoemulsion using hemp oil, Mibelle made it water-soluble and stable in cosmetic formulations.

Its combination with an extract from Swiss stone pines also helps the product fight inflammation. Lipobelle Pino C exploits the anti-inflammatory and regenerating effects of CBD for cosmetic benefits such as easing facial tension, reducing inflammation, and regenerating tissue.

Mibelle Biochemistry has been a pioneer in utilising interesting biochemical concepts for its active ingredients. In 2008, it gained a first-mover advantage with the launch of its active ingredient PhytoCellTec Malus Domestica, which involved the application of stem cells in cosmetics for the very first time.

In 2019, Mibelle utilised its PhytoCellTec technology to launch the PhytoCellTec Goji, which stimulates the mesenchymal stem cell (MSC) culture with goji stem cells for enhancing face shape by preventing the skin from sagging. The success of this technology and other recent innovations has allowed the company to achieve a 15 percent growth rate annually.

Each year, Frost & Sullivan presents a Company of the Year award to the organisation that demonstrates excellence in terms of growth strategy and implementation in its field.

The award recognises a high degree of innovation with products and technologies, and the resulting leadership in terms of customer value and marketpenetration.

Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

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Mibelle Biochemistry announces: Mibelle Biochemistrys Ability to Introduce Breakthrough Active Ingredients for the Personal Care Market by Frost and...

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La Prairies New Collection Is Inspired by a Platinum Meteor Shower that Lasted 200 Million Years – Surface Magazine

By daniellenierenberg

What is the value of time? La Prairie has been pondering that question for nearly a century, since founder Dr. Paul Niehans, who earned the sobriquet father of cellular therapy, began experimenting with remedies for longevity in 1931 at the Clinique La Prairie in Montreux, Switzerland.

Over the years, the heritage Swiss luxury house has lived at the forefront of beauty innovation, producing indulgent face creams and serums that introduce science into skincare and incorporate rarefied ingredients such as caviar, gold, and now platinum. The precious metal is the anchor of new the Platinum Rare Haute-Rejuvenation collection, the brands latest fountain-of-youth formula offered in a seven product range.

Housed in an assortment of sculptural, amethyst-shaded vessels with enhanced platinum accents, the velvety creams and elixirsperfumed with La Prairies signature scentshowcase a new science dubbed Haute-Rejuvenation. At the core of it is a cellular renewal process that smooths wrinkles, improves skin moisture, restores volume, and induces a vibrant glow. By invigorating epidermal stem cells, it in effectturns back time to more youthful skin.

La Prairies Exclusive Cellular Complex is a life force for the skin. It uses biotechnological research to give new life and energy back to the very cells where beauty is born. It invigorates and nourishes epidermal stem cells to enable them to resume cellular renewal and functionality similar to that of young skin.

When we age, the skins natural rejuvenating capacity decreases, leading to the appearance of signs of aging, says Dr. Jacqueline Hill, the brands global director of strategic innovation. La Prairies Science of Haute-Rejuvenation seeks to specifically modulate and stimulate the skins natural network of interconnected rejuvenating processes to compensate for the age-related decrease of its performance.

Another pillar of the brands history is art. To celebrate the launch of Platinum RareHaute Rejuvenation, La Prairie commissioned the acclaimed British composer Max Richter and Japanese artist Nobuhiro Nakanishi to collaborate on an immersive installation set to debut at this years West Bund Art & Design in Shanghai (Nov. 12-15). Richter masterminded a score for Nakanishis layer drawing Echo of Time, a sculptural work with a sequential photography series of the Swiss Alps at twilight.

The duo was tasked to consider the essence of time and space, particularly a billion -year-long meteor shower responsible for bringing platinum to earth. For his contribution, Nakanishi traveled to Niederhorn peak in the Swiss Alps where he photographed a vibrant sunrise of blue, red, and purplethe colors that imbue Platinum Rares bottle design. The colors dyed the mountains and at the same time, the sky awakened and became amethyst, Nakanishi says of the scene. The mountainous scenery in Switzerland is the perfect place to illustrate the notion of timeless nature through the clearness of the water, the air, and the reflection of light created by nature itself.

Richters melodic composition begins with pulsating choral strings that give way to an individual acoustic figure meant to stimulate the feeling of entering a new landscape. It provokes a dynamic encounter with a new world and makes you feel alive, he says. To Richter, time is mysterious and doesnt always move at the same speed. This is the kind of thing a piece of music can trigger: it can stop time or speed it up, it can make time feel more intense.

Its a synergetic notion: Manipulating the effects of time is something La Prairie does best.

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La Prairies New Collection Is Inspired by a Platinum Meteor Shower that Lasted 200 Million Years - Surface Magazine

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Covid-19 Impact On Orthopedic Regenerative Medicine Market 2020 Future Development, Manufacturers, Trends, Share, Size And Forecast to 2027 |…

By daniellenierenberg

The report on Global Orthopedic Regenerative Medicine Market is a dependable point of reference heralding high accuracy business decisions on the basis of thorough research and observation by seasoned research professionals at CMI Research. The report on global Orthopedic Regenerative Medicine market evidently highlights the causal factors such as demand analysis, trend examination, and technological milestones besides manufacturing activities that have been systematically touched upon to instigate systematic growth projection.

This CMI Research report on global Orthopedic Regenerative Medicine market systematically studies and follows noteworthy progresses across growth trends, novel opportunities as well as drivers and restraints that impact growth prognosis.

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Which market players and aspiring new entrants may witness seamless entry?

Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

Predicting Scope: Global Orthopedic Regenerative Medicine Market, 2020-2027

Elaborate research proposes global Orthopedic Regenerative Medicine market is likely to experience an impressive growth through the forecast span, 2020-2027, ticking a robust CAGR of xx% USD. The Orthopedic Regenerative Medicine market is anticipated to demonstrate a whopping growth with impressive CAGR valuation. The Orthopedic Regenerative Medicine market is also likely to maintain the growth spurt showing signs of steady recovery.

For appropriate analysis of all the market relevant information as well emerging trends and historical developments in the Orthopedic Regenerative Medicine market, CMI Research has referred to various primary and secondary research practices and contributing factors.

Regional Overview: Global Orthopedic Regenerative Medicine Market

The report specifically sheds light upon note-worthy business discretion, popular trends investment probabilities aligning with budding opportunities as well as breakthrough developments in policies and monetary inclination echoing investor preferences in Orthopedic Regenerative Medicine space.

Competitive Landscape: Global Orthopedic Regenerative Medicine Market

Further in the report, readers are presented with minute details pertaining to significant company profiles, product development, on pricing, production and vital information on raw material and equipment developments also form crucial report contents in this CMI Research report.

Have Any Query? Ask Our Expert @: https://www.coherentmarketinsights.com/insight/request-customization/3566

Segmentation Based on Orthopedic Regenerative Medicine Market Types:

By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

Global Orthopedic Regenerative Medicine Market Size & Share, By Regions and Countries/Sub-regions:

Asia Pacific: China, Japan, India, and Rest of Asia Pacific

Europe: Germany, the UK, France, and Rest of Europe

North America: the US, Mexico, and Canada

Latin America: Brazil and Rest of Latin America

Middle East & Africa: GCC Countries and Rest of Middle East & Africa

The regional analysis segment is a highly comprehensive part of the report on the global Orthopedic Regenerative Medicine market. This section offers information on the sales growth in these regions on a country-level Orthopedic Regenerative Medicine market.

The historical and forecast information provided in the report span between2020 and 2027. The report provides detailed volume analysis and region-wise market size analysis of the market.

Report Investment, a Priority: Explains CMI Research

This report also helps market participants to organize R&D activities aligning with exact market requirements

The report resonates critical findings on decisive factors such as downstream needs and requirement specifications as well as upstream product and service development

The report aids in reader comprehension of the market based on dual parameters of value and volume.

This CMI Research initiated research output on Orthopedic Regenerative Medicine market is a ready-to-refer handbook of noteworthy cues for easy adoption by market players and stakeholders

CMI Research skillfully underpins a vivid segment analysis of the global Orthopedic Regenerative Medicine market, rendering appropriate inputs about the revenue generation capabilities of each segment.

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Thanks for reading our report. If you have any further questions, please contact us. Our team will provide you with the report tailored to your needs.

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Coherent Market Insightsis a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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Explainer: What is Crispr and why did it win the Nobel prize? – Chemistry World

By daniellenierenberg

Emmanuelle Charpentier and Jennifer Doudna have scooped the 2020 Nobel prize in chemistry for the development of a method for genome editing. Specifically, theyve been awarded the prize for their discovery of the CrisprCas9 genome editing technique that allows scientists to make precise alterations to the genetic code of living organisms. CrisprCas9 is a powerful tool that could revolutionise many aspects of our lives, from medical treatments to the way we produce food. Its also seen its fair share of controversy in recent years. Here, we take a deeper look at these genetic scissors and why theyve won the Nobel prize.

Since Charpentier and Doudna began investigating the CrisprCas9 system in 2011, the field has exploded. Due to the relative simplicity and affordability of Crispr systems, researchers around the world have been able to apply the tools to all manner of different problems. Today there are entire journals, conferences and companies dedicated to the technique.

The ability to cut any DNA molecule at a chosen site has huge potential from treating genetic illnesses to creating disease-resistant crops. Trials have even shown how Crispr-delivered genetic modifications can spread through populations of mosquitoes and stop malaria infections such gene-drives offer a way to eliminate the disease altogether. And in the face of the Covid-19 pandemic, researchers have found ways to use Crispr in rapid coronavirus diagnostic tests and have also proposed using it to attack the viruss genome.

As Claes Gustafsson, chair of the Nobel committee for chemistry, said at the award announcement, There is enormous power in this genetic tool, which affects us all.

Crispr technology has even been used to make more delicious beer.

The whole Crispr gene editing tool has been adapted from the immune system of bacteria. The term Crispr comes from clustered regularly interspaced short palindromic repeats, which refers to distinct genetic sequences found in the genomes of bacteria. Each Crispr sequence is transcribed into RNA sequences that will target the DNA of a virus. These sequences also include cas (Crispr-associated) genes that code for DNA-cutting Cas enzymes. Together, the guide RNA and Cas enzyme form a complex that hunts out viral DNA and chops it up.

In Crispr gene editing, scientists repurpose this system by designing a guide RNA sequence of around 20 nucleobases that matches up to a DNA sequence they wish to target in a cells genome. This RNA sequence is paired with the Cas9 enzyme that will cut the DNA strand at the targeted site. The whole DNA sequence coding for both these components of the Crispr-Cas9 tool can be delivered to the target cell via a plasmid.

The tool can therefore be used to edit a cells genome with incredible precision for example, it can cut out a dysfunctional gene associated with a hereditary illness. And if the healthy version of the gene is also delivered to the cell, the cells own repair system will then incorporate the healthy strands at the site where it has been cleaved.

In 2011, when investigating the bacteria Streptococcus pyogenes, Charpentier discovered a molecule called tracrRNA that forms a key part of the CrisprCas system in bacteria.

Meanwhile, Doudna had been investigated the function of the cas genes, and learned that the Cas proteins they code for are involved in cutting up DNA as part of the bacterial immune system against pathogenic viruses.

That year Charpentier teamed up with Doudna to investigate the system further. Together they revealed how the Cas9 protein, CrisprRNA and tracrRNA worked together to snip DNA strands into two parts. They then simplified the system by combining the CrisprRNA and tracrRNA into a single molecule guide RNA making it easier to use, and showed how this could be used to cut any DNA strand at a site of their choosing, opening the door to using the tool in all manner of genome editing experiments.

While previous tools for genetic editing existed before Crispr-Cas9, the new tools are much simpler and cheaper. This has led to the huge expansion of the field by making gene editing accessible for scientists all around the globe.

For years Crispr has been at the centre of a long-running patent dispute. Shortly after Doudna and Charpentiers discovery, Feng Zhangs team the Broad Institute in Cambridge, US, patented a way to use the technique in eukaryotic cells. There have been protracted court battles between Doudnas group at the University of California in Berkeley, US, and the Broad team over who holds the key piece of intellectual property. In the meantime, numerous groups and companies have been granted patents for many new Crispr-related technologies, meaning that as time goes on, the original patents at the centre of the dispute are becoming less relevant.

Another area of controversy surrounds the potential consequences of using genome editing tools at all. As the genome is so complex, we cant always know what will happen when we edit genes. Some genes have multiple and often unknown functions editing them to correct for one problem could end up creating new unforeseen ones. This is particularly important when it comes to editing germline cells (those that can be passed on to an organisms children), because the modified genes can be inherited by future generations.

As a relatively new technique, we also know that Crispr itself isnt perfect. Some studies have shown off-target cuts, where the tool has snipped DNA strands at additional locations to the desired site. This clearly can have harmful consequences, and so many researchers are looking into ways to improve the technique and make it more suitable for medical uses.

With these concerns in mind, scientists worldwide including Doudna and Charpentier have called for a moratorium on editing human germline cells, until we can know more about the consequences. Such calls intensified after the rogue Chinese scientist He Jiankui edited human embryos that were then brought to term in 2018. He is now serving a three year prison sentence for conducting the study.

Several clinical trials have already begun on Crispr-based therapies, with promising reports emerging this year. In February, the first study to look at a cancer treatment using Crispr-edited immune cells reported that the modified cells were safe, with no serious side-effects in the three patients studied. While the efficacy of the treatment on the cancers was minimal, it may help to inform future Crispr-based T-cell treatments.

One month later, a patient with hereditary blindness became the first person ever to have a CrisprCas9 therapy directly administered into their body. And in June, the Swiss gene-editing company Crispr Therapeutics announced that two patients with beta thalassaemia and one with sickle cell disease would no longer require blood transfusions after their bone marrow stem cells were edited using Crispr techniques.

Earlier this week, Doudna launched a new company, Scribe Therapeutics, to begin work on treatments for amyotrophic lateral sclerosis.

Other Crispr-based technologies are coming closer to commercial reality. For example, the US genome engineering company eGenesis is developing ways to use the technique to edit pigs genes so that their organs might be transplanted safely into humans. In the agricultural sector, many companies are working on ways to use Crispr to speed up the selection process for crops with desirable traits such as disease-resistance or improved flavour.

At the fundamental level, researchers are working on ways to improve the system itself. By using alternative Cas proteins, some groups hope to make the tool more effective and easier to use in certain settings. Doudnas group recently reported on a CasX protein that is smaller than Cas9 and potentially easier to introduce into target cells.

Delivering DNA into cells and tissues is an important part of gene therapy, even more so for Crispr-Cas9 approaches because plasmids carrying this system are very large. This research paper describes a non-viral vector for delivering plasmid DNA carrying Crispr-Cas9 into tumour spheroids, which are good in vitro models for tissues but also challenging transfecting targets.

1 S J Zamolo, T Darbre and J-L Reymond, Transfecting tissue models with CRISPR/Cas9 plasmid DNA using peptide dendrimers, Chem. Commun., 2020, DOI: 10.1039/d0cc04750c

Regulating the function of Crispr-Cas9 is on the agenda for many researchers because the ability to restrict it in a spatial and temporal manner opens the door to precisely manipulating genomes and minimising any side effects. By introducing photolabile groups into the system, these researchers have shown how they can regulate Cas9 activity with light

2 Y Wang et al, Photocontrol of CRISPR/Cas9 function by site-specific chemical modification of guide RNA,Chem. Sci., 2020, DOI: 10.1039/d0sc04343e

It seems that Crispr-Cas systems arent just handy for gene editing. This paper describes how the Crispr-Cas system was used to assemble a multi-enzyme cascade containing five distinct enzymes. The team behind the work hope it could be the beginnings of a general method for building complex scaffolded biocatalytic pathways

3 S Lim et al, CRISPR/Cas-directed programmable assembly of multi-enzyme complexes, Chem. Commun., 2020, 56, 4950 (DOI: 10.1039/d0cc01174f)

And to round things off, here are some reviews on how Crispr-Cas9 works, the delivery processes for therapeutic nanoparticles and the physiological obstacles for those process

4 Y Xu, R Liu and Z Dai, Key considerations in designing CRISPR/Cas9-carrying nanoparticles for therapeutic genome editing, Nanoscale, 2020, DOI: 10.1039/d0nr05452f

5 Y Gong et al,Lipid and polymer mediated CRISPR/Cas9 gene editing, J. Mater. Chem. B, 2020,8, 4369 (DOI: 10.1039/d0tb00207k)

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Explainer: What is Crispr and why did it win the Nobel prize? - Chemistry World

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Covid-19 Impact on Global Orthopedic Regenerative Medicine Market Rapid Growth By 2019 2027 | Curasan, Inc., Carmell Therapeutics Corporation, Anika…

By daniellenierenberg

Latest released the research study on Global Orthopedic Regenerative Medicine Market, offers a detailed overview of the factors influencing the global business scope. Orthopedic Regenerative Medicine Market research report shows the latest market insights, current situation analysis with upcoming trends and breakdown of the products and services. The report provides key statistics on the market status, size, share, growth factors of the Orthopedic Regenerative Medicine. The study covers emerging players data, including: competitive landscape, sales, revenue and global market share of top manufacturers are Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

Definition:

Orthopedic Regenerative Medicine strategy sends messages to the customers or subscribers in predefined schedule. However, other forms of media can also be used in Orthopedic Regenerative Medicine. It is the most common form of marketing as multiple messages can be sent in low costs. Orthopedic Regenerative Medicine is used to achieve business objectives such as increasing sales, maintaining communications with customers while saving the business time. Moreover, the users can personalize each of the email messages and increase conversion rate.

Market Drivers

Market Trend

Opportunities

Challenges

Detailed Segmentation:

By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

Analyst at CMI have conducted special survey and have connected with opinion leaders and Industry experts from various region to minutely understand impact on growth as well as local reforms to fight the situation. A special chapter in the study presents Impact Analysis of COVID-19 on Global Orthopedic Regenerative Medicine Market along with tables and graphs related to various country and segments showcasing impact on growth trends.

o North America (United States, Canada, and Mexico)

o Europe (Germany, France, UK, Russia, and Italy)

o Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)

o South America (Brazil, Argentina, Colombia)

o Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Download PDF Brochure of Research Report @https://www.coherentmarketinsights.com/insight/request-pdf/3566

Strategic Points Covered in Table of Content of Global Orthopedic Regenerative Medicine Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Orthopedic Regenerative Medicine market

Chapter 2: Exclusive Summary the basic information of the Orthopedic Regenerative Medicine Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Orthopedic Regenerative Medicine

Chapter 4: Presenting the Orthopedic Regenerative Medicine Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying market size by Type, End User and Region 2014-2019

Chapter 6: Evaluating the leading manufacturers of the Orthopedic Regenerative Medicine market which consists of its Competitive Landscape, Peer Group Analysis

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries (2019-2027).

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Orthopedic Regenerative Medicine Market is a valuable source of guidance for individuals and companies in decision framework.

Data Sources & Methodology

The primary sources involves the industry experts from the Global Orthopedic Regenerative Medicine Market including the management organizations, processing organizations, analytics service providers of the industrys value chain. All primary sources were interviewed to gather and authenticate qualitative & quantitative information and determine the future prospects.

In the extensive primary research process undertaken for this study, the primary sources Postal Surveys, telephone, Online & Face-to-Face Survey were considered to obtain and verify both qualitative and quantitative aspects of this research study. When it comes to secondary sources Companys Annual reports, press Releases, Websites, Investor Presentation, Conference Call transcripts, Webinar, Journals, Regulators, National Customs and Industry Associations were given primary weight-age.

Get Discount on This Premium Report @https://www.coherentmarketinsights.com/insight/request-discount/3566

What benefits does CMI research study is going to provide?

Definitively, this report will give you an unmistakable perspective on every single reality of the market without a need to allude to some other research report or an information source. Our report will give all of you the realities about the past, present, and eventual fate of the concerned Market.

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Southeast Asia.

About Author:

Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having office at global financial capital in the U.S. Our client base includes players from across all business verticals in over 150 countries worldwide. We are uniquely positioned to help businesses around the globe deliver practical and lasting results through various recommendations about operational improvements, technologies, emerging market trends and new working methods.

Mr Raj ShahCoherent Market Insights 1001 4th Ave,#3200 Seattle, WA 98154, U.S.Phone +1-206-701-6702sales@coherentmarketinsights.com

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Covid-19 Impact on Global Orthopedic Regenerative Medicine Market Rapid Growth By 2019 2027 | Curasan, Inc., Carmell Therapeutics Corporation, Anika...

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The best anti-aging skin care products to use in your 40s – TODAY

By daniellenierenberg

For most of my life, Ive credited my good skin to two products: a gentle cleanser and a powerful sunscreen. But something happened when I hit my 40s I noticed my skin no longer glowed like it used to and it always seemed to look and feel dry. When I noticed a few sunspots on the top of my right cheek, I realized it was time to elevate my morning and evening beauty routines.

Fine lines, dryness, sunspots and a loss of firmness are all things women begin to deal with in their 40s, says Dr. Mona Gohara, associate clinical professor of dermatology at Yale School of Medicine. Plummeting estrogen levels directly affect collagen production, skin thickness and hydration, so its important to develop an anti-aging skin care program, and stick with that program, during this decade.

With so many anti-aging products on the market boasting ingredients youd never thought youd put on your face (acids! oils!), it can be hard to figure out where to start.

So we reached out to top dermatologists across the country to help simplify the process. Everyone we spoke to listed sunscreen as the most important topical to keep forty-something skin looking great, followed by the appropriate cleanser, anti-ager, moisturizer and exfoliator.

Below, you'll find a quick guide to what youll need when it comes to choosing the right ingredients for your face, because as Gohara stressed, At this age, prevention not just correction should still be your goal.

When shopping for a sunscreen in your 40s, experts note you should be looking for the words zinc oxide, titanium dioxide and iron oxide on the label.

Zinc oxide and titanium dioxide protect against both UVA and UVB rays, while iron oxide guards against skin-damaging blue light from computer and cell phone screens, notes Gohara. Look for an SPF of 30 or higher and slather on half a teaspoon on your face daily, including your ears and neck, before applying makeup. If you drive, be sure to protect your hands, as UVA rays can penetrate glass, resulting in sunspots.

EltaMD UV Facial Broad-Spectrum SPF 30+, despite having zinc oxide, doesnt leave your skin with a whiteish tint. It's also formulated with hyaluronic acid, which can help keep your skin hydrated and firm.

Supergoop! Unseen Sunscreen SPF 40 is oil-free, goes on clear and works as a makeup primer to control shine. The vegan formula should be applied as the last step in your skin care regimen before you apply makeup, at least 15 minutes before you step out into the sun.

Gohara recommends keeping this brush-on SPF powder in your glove compartment. With SPF 50, the water-resistant formula provides both protection and sheer tinted coverage.

In your 40s, derms recommend using a cleanser containing ceramides, glycerin, and vitamin E.

Ceramides are lipids that help retain moisture, glycerin is a humectant that pulls water from the deepest layers of the skin, while vitamin E also adds moisture, says Dr. Martha Viera, volunteer faculty at the University of Miami Department of Dermatology. Before cleansing, wash your hands thoroughly to avoid dirt or bacteria from touching your skin, and splash your face with lukewarm water prior to application to activate the cleansing ingredients. Start and end your day by washing with a quarter-sized amount of cleanser, applying it in a circular motion over your face and neck.

Viera likes La Roche-Posay Toleriane Hydrating Gentle Cleanser because its designed to balance the skins pH levels, protecting the skins sensitive barrier. It is formulated to cleanse the skin without stripping it of moisture thanks to ingredients such as glycerin and niacinamide.

Bioderma Sensibio Foaming Gel has a soothing gel-cream texture that turns to foam when activated. The gentle formula works to remove makeup while also hydrating the skin.

Dove White Beauty Bar with Deep Moisture is great for sensitive skin as it combines cleansing ingredients with a dose of moisturizing cream. It is suitable for sensitive skin and gentle enough to use on both your face and body.

Youll need two anti-aging products in your 40s: a morning serum that contains moisture-drawing hyaluronic acid and antioxidants, and a night serum that includes peptides and retinol (retinol should be applied at night as it can make your skin sensitive to the sun).

Be sure to layer your anti-ager under your moisturizer and consider a serum which, thanks to their small molecular makeup, absorbs quickly and deeply, says Dr. Arisa Ortiz, director of laser and cosmetic dermatology at the University of California at San Diego. Antioxidants like vitamin C, E, B5, and resveratrol attach themselves to free radicals, preventing the free radicals from latching onto and damaging healthy skin cells, while retinoids and peptides exfoliate dead skin while stimulating collagen and softening lines.

Obagi Professional-C Serum contains ascorbic acid, a vitamin C derivative that softens the look of pigmentation and encourages collagen growth. It can be applied to the face, neck and chest in the mornings and followed with sunscreen.

Dr. Ortiz likes Rodan + Fields Intensive Renewing Serum because its lightweight, absorbs easily and has the highest levels of vitamin A for a nonprescription product. The serums are held in small capsules that you can open to smooth all over your skin.

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This dermatologist-approved pick is suitable for normal, sensitive and dry skin. The formula works to not only visibly brighten the skin but also reduce the appearance of fine lines and wrinkles.

To tackle dry skin in your 40s, Gohora recommends looking for ingredients that help boost and maintain moisture, including niacinamide, ceramides, glycerin and hyaluronic acid.

To be most effective, apply your moisturizer after your anti-aging serum. Dot your cheeks, forehead, chin and nose, and then rub in a circular upward motion both morning and night, notes Dr. Paul Jarrod Frank, clinical assistant professor of dermatology at The Icahn School of Medicine at Mount Sinai Hospital and author of "The Pro-Aging Playbook."

This moisturizer comes in a soothing light gel-cream formula and uses hyaluronic acid to fortify the lipid barrier to prevent dryness. It can be applied twice daily after a serum is applied to the skin.

Pause Collagen Boosting Moisturizer contains skin-conditioning fatty acids and B vitamins that work to promote healthy skin. The formula features the brand's "Pause Complex," which combines vitamins, antioxidants and peptides that help boost collagen production.

Dr. Frank likes Caudalie Vinoperfect Brightening Moisturizer, a lightweight gel that contains niacinamide and hyaluronic acid for a boost of hydration. It can be applied in the mornings to the face and neck in order to brighten and moisturize the skin.

Acids in exfoliators help remove layers of dead skin cells to promote cell turnover, clear pores and reduce pigmentation. Look for words such as glycolic, lactic, mandelic or salicylic acid on the label.

Apply a dime-sized amount of facial exfoliator two to three times a week at night, Jarrod told us. Just dont overdo it too much exfoliation can rob skin of the fatty acids that protect the skin barrier.

This treatment addresses skin care concerns by exfoliating, purifying and smoothing the skin. Depending on your skin type, it can be used up to three times a week to improve the appearance of your complexion.

Dr. Frank likes Drunk Elephant T.L.C. Sukari Babyfacial, which has an eye-popping 25% glycolic and lactic acid blend to smooth and brighten skin. Since the formula uses clean ingredients, it is fragrance-free and won't leave the skin feeling irritated.

A derivative of salicylic acid can be found in Lancme Renergie Lift Multi-Action Ultra Milk Peel, a leave-on exfoliator that you apply after cleansing and before your moisturizer. The milky consistency feels smooth on the skin and should be applied with a cotton round.

Dermalogica Daily Microfoliant contains salicylic acid and foams up into a paste when activated with water. The formula can be applied daily to the skin to slough off dead skin cells and even out your complexion.

Although it is a bit of a splurge, this daily serum uses rich ingredients such as mandelic and lactic acid to unclog pores, even skin texture, reduce the appearance of fine lines and more. It can be applied to the face and neck to reveal brighter skin over time.

Bonus products: Our experts noted theres no harm incorporating a neck or eye cream into your routine in your 40s.

Look for targeted ingredients in a neck cream, such as tetrapeptides to promote collagen formation, antioxidant algae extract to protect against free radicals, glucosamine to stimulate hyaluronic acid and improve hydration while decreasing wrinkles, and omega-3 fatty acids to add moisture.

Apply a dime-size amount in the morning and evening, working your way up the neck to the jawline until the product is evenly distributed and absorbed, notes Gohara. Neck creams tend to be thicker than traditional moisturizers, so allow more time for them to absorb and be sure to follow up with a sunscreen in the morning.

Viera likes Revision Nectifirm Advanced, which uses peptides to smooth dry skin. Other ingredients such as lingonberry extract work with the skin's natural microbiome to provide soothing results.

Prai Ageless Throat & Dcolletage Creme has shea butter and hyaluronic acid to plump lines and effectively smooth the skin. For best results, the brand recommends applying the moisturizer twice daily to target areas.

Suzanne Somers Organics Neck Firming Crme contains tetrapeptides to support collagen and elastin growth. The formula is packed with skin-boosting ingredients such as hyaluronic acid and Swiss apple stem cells that help to combat signs of aging.

This cream can be applied twice daily in upward motions to hydrate and revitalize the skin. The formula is quick-absorbing, so it won't leave the skin feeling oily or greasy.

Look for ingredients like caffeine to reduce puffiness and dark circles, niacinamide and hyaluronic acid to plump fine lines, and arginine, growth factors, and retinol to boost collagen production.

Apply a pea-sized amount twice daily by gently patting the cream on with your ring finger, Viera said. Be sure to use any eye products containing retinoids at night to avoid sun sensitivity.

Dr. Viera likes Neocutis Lumire Illuminating Eye Cream, a lightweight cream that contains antioxidants to protect against environmental damage. In addition to its protective qualities, it can also be used to reduce the appearance of puffiness and dark circles.

RoC Retinol Correxion Eye Cream uses a derivative of vitamin A to accelerate the removal of dead skin cells, leaving you with visibly brighter skin. It targets concerns such as crow's feet, under-eye wrinkles, deep wrinkles and fine lines.

Skinbetter Science Interfuse Eye Treatment Cream contains caffeine to reduce puffiness and vitamin C to brighten the under-eye area. It is packed with humectants to help lock in moisture and promote healthy skin.

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The best anti-aging skin care products to use in your 40s - TODAY

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Why Silicon Valley Execs Are Investing Billions to Stay Young – Robb Report

By daniellenierenberg

Entrepreneur Dave Aspreys end-of-life plans are quite simple, really, even if some of his ambitions sound laughably optimistic to most of us.I want to die at a time and by a method of my own choosing, and keep doing awesome things until that day, he tells me. I dont think its outrageous to believe Ill make it to 180 years old. And if I run out of energy, itll just be because I did too much cool shit for my own good.

Asprey is strolling across his lush property in British Columbia, holding up his phone and pointing out the specimens in this years garden as we chat over Zoom in the midst of the global pandemic. Hes protecting his skin from the sun with a goofy Outdoor Research hat and wearing a long string of beads that he says are each over a hundred years old, from cultures around the world.

Asprey, 48, is the founder of the Bulletproof wellness empire and a vocal champion of the movement to extend human life expectancy beyond 100 years. Hes made millions by experimenting on his own body and packaging his home-brewed discoveries into books, a podcast, consulting services and consumer products (you may have even tried his butter-laced coffee). Asprey, who was a web-security executive before he became the Bulletproof Executive, is just one of a cadre of tech elite who have begun directing their attentionand truckloads of moneytoward the problem of life extension. Jeff Bezos, Peter Thiel, Sergey Brin, Larry Ellisonname a Silicon Valley A-lister and he or she is likely funding longevity research, experimenting with anti-aging interventions or both. These are the masters of the universe who see no reason they cant take the tech industrys optimization obsession and apply it to the ultimate challenge: conquering death itself.

And their efforts appear to be paying off: Thanks to a recent explosion of advances in longevity medicine, Aspreys vision of living healthfully into his second century might not be so crazy. In fact, for people in middle age right now, a handful of therapies in clinical trials have the potential, for the first time in human history, to radically transform what old age looks like. If the life extensionists are right, a person whos 40 today might reasonably expect to still be downhill skiing, running a 10K or playing singles tennis at 100.

Dave AspreyDave Asprey

If you do anti-aging right, Asprey insists, youll have a level of resilience and energy to fight what comes your way. If you get Covid-19, youre less likely to become very sick. The idea is that at a cellular level, youre making yourself very hard to kill.

The most extreme of the controversial interventions Asprey has undergone involved having stem cells extracted from his own bone marrow and fat and then injected into hundreds of locations on his body. Into every joint, between every vertebra and into my cerebrospinal fluid, face and sex organs, he tells me cheerfully. For what I spent on that, I could have bought a really nicely appointed Tesla.

He trots up a flight of stairs to his home office, which sits above a million-dollar lab filled with health gadgets, such as a cryochamber, a hypoxic trainer and an AI-enabled stationary bike. For a wealthy person, investing in your body should be a major part of your Im rich strategy, he explains. Personally, I think you should be spending at least 2 to 3 percent of your net worth on health and longevity. Get a personal chef who can cook you the right food. Its not that hard.

It might be an exaggeration to say BioViva CEO Liz Parrish believes death is optional, but for her, Aspreys goal of living to 180 shows a distinct lack of ambition. If you can reach homeostasis in the body, Parrish says, where its regenerating itself just a little bit faster than its degrading, then what do you die of? An accident or natural disaster, probably. Theres no expiration date at 90 or 100 years old.

Tall, blond and fit, Parrish cuts a strikingly youthful figure at 49one that might convince you to order whatever shes having. But, like Asprey, she has received criticism from the longevity research community for becoming patient zero in her own experimental drug trial, aimed at halting aging at the cellular level. In 2015, Parrish underwent telomerase and follistatin gene therapies in Bogota, Colombia. The procedures involved receiving around a hundred injections of a cocktail of genes and a virus modified to deliver those new genes into her bodys cells. The objective was to prevent age-related muscle loss and lengthen her telomeres: the caps at the end of our chromosomes. Scientists have identified their unraveling as not only a marker of aging but also a potential cause of age-related decline.

Liz ParrishLiz Parrish

Parrish told the media about her clandestine experiment and has published periodic updates on her condition in the five years since, and she reports that she has indeed increased her muscle mass and lengthened her telomeres. Parrishs punk-rock approach stems from her conviction that the medical-research communityboth the Food and Drug Administration (FDA) and researchers who arent business-mindedis moving too slowly, with too much red tape, when it comes to advancing aging therapeutics. But gene therapy is a relatively new area of medicine that brings with it a host of new risks, including cancer, severe immune reactions and infections caused by the viral vector used to deliver the drug.

Parrish downplays such worries. There may be risks, she tells Robb Report. But the known risk is that youre 100 percent likely to die. So you have to decide for yourself if the potential benefit outweighs that.

Humans have always aspired to find the fountain of youth, so people might be skeptical about the fact that anti-aging technologies are working now, says British investor and businessman Jim Mellon. But the fact is that this is finally happening, and we need to seize the moment. Mellon cofounded Juvenescence, a three-year-old pharmaceutical company thats investing in multiple technologies simultaneously to increase the odds of bringing winning products to market.

Mellon, 63, has made his fortune betting on well-timed investment opportunities, and he predicts that a new stock-market mania for life extension is just around the corner. This is like the internet dial-up phase of longevity biotech, he enthuses. If youd invested in the internet in the very early days, youd be one of the richest people on the planet. Were at that stage now, so the opportunity for investors is huge. According to a report by Bank of America Merrill Lynch, hes not wrong: The market for technologies to increase human life span is projected to grow sixfold to $610 billion in just the next five years.

When I talk to Mellon in the late spring, hes sequestered on the rugged coast of the Isle of Man, a tiny spit of land in the Irish Sea. Despite being what he describes as imprisoned there for 15 weeksand countingduring the Covid-19 shutdown, hes jovial and chatty and wants to make it clear that his interest in life extension is much more than financial. Working to extend life is an ethical cause, he says. If we can help people to live healthfully until the end of life, well transform the world completely. Well reduce a huge amount of pressure on failing health-care systems, and well have to reimagine pension and life insurance. This should be the number-one tick in anyones investment portfolio.

If youd like to get on board with this social-impact view of longevity, it helps to understand the trajectory of aging today. In Americas most affluent neighborhoods, the average life span is about 88 years. (Meanwhile, in this countrys poorest, it hovers around a meager 66 because of a raft of inequalities, such as diet, stress, smoking, pollution and health care.) For most people, health starts gradually diminishing in the last 15 years of life with the onset of chronic conditions, including arthritis, neurodegeneration and diabetes. If we could eliminate such diseases of aging, experts say, the US could save an estimated $7.1 trillion in health-care costs over the next 50 years. (Quite where all these sprightly centenarians might live on this already densely populated planet remains to be seen.)

Jim MellonEric Verdin

One of Mellons bets is on a class of drugs called senolytics, which destroy senescent cells: the so-called zombie cells that, for complex reasons, stop dividing as we age. Senescent cells harm the body by secreting compounds that cause inflammation in surrounding tissues. Many age-related conditionsarthritis, diabetes, Alzheimers, cancerhave an inflammatory component, and studies suggest that a buildup of senescent cells is a large part of the problem.

A number of biotech start-ups are devel- oping drugs that target cell senescence, but the furthest along is Unity Biotechnology, a company in South San Francisco that has three drugs in clinical trials to address aging conditions, starting with osteoar- thritis of the knee. Unity raised more than $200 million from such big names as Thiel and Bezos, who chipped in through their investment firms, before going public in 2018. Since then, Mellon has also bought a small stake.

The holy grail of senolytics will be the development of a preventive therapy to wipe out senescent cells in the body before they cause conditions of aging, theoretically extending life span. In June, a team from Sloan Kettering published new breakthrough research showing that CAR T cellstypically used for precision cancer therapycan also be used to target and kill senescent cells. Prescription senolytics for anti-aging therapy are still years away, but unsurprisingly, theres an audience of longevity enthusiasts who want to access such anti-aging miracles yesterdayand no shortage of FDA-unapproved ways to chase after them. For instance, after a few studies examined the senolytic effects of a chemotherapy drug called dasatinib, the website FightAging.org published a step-by-step guide to senolytic self-experimentation using chemotherapeutics.

It doesnt take a Ph.D. in biochemistry to guess that taking off-label chemo drugs might come with harmful side effects, but that hasnt stopped a zealous group of body-hackers from trying it themselves and chronicling their efforts online. The internet is littered with novice longevity adviceand sketchy anti-aging companies eager to separate the hopeful and desperate from their money, like the company that charges $8,000 for transfusions of plasma from the blood of teenagers and early-twentysomethings (yes, just like Gavin Belson on HBOs Silicon Valley). Many of these are at best ineffective and at worst deadly, since the same cellular systems that fuel growth in young people might cause cancer when tipped into overdrive. Imagine the tragic irony of paying tens of thousands for a therapy that promises to help you live longer but actually causes the cancer that kills you.

Adobe

Beyond the obvious red flags of repurposed chemo drugs and the bloodletting of teens, it can be difficult for a layperson to separate the world-changing longevity breakthroughs from the terrible ideas. Enter one of the worlds leading experts on longevity to help make sense of things.

Eric Verdin, 63, is president and CEO of the Buck Institute, a globally renowned center for aging research just outside San Francisco in Marin County. Verdin is bullish on the promise of living healthfully to at least 100. Today. But 180? Dont count on it. My prediction, based on everything we know today, is that getting to 120 is about the best we can do for the foreseeable future. Ill bet my house were not going to see anyone live to 180 for another 200 years, if ever, he says. But making everyone a healthy centenarian, this is something we can do today. And thats something to be excited about.

Verdins own lab at the Buck Institute studies the aging immune system and how its affected by lifestyle factors, such as nutrition and exercise. Informed by this research, Verdin follows a time-restricted diet in which he eats all of his meals in an eight-to-nine-hour window (similar to the Buchinger Wilhelmi process) and gets plenty of exercise mountain biking in Marins steep hills. The good news is that over 90 percent of what causes diseases of aging is environmental, and that means its within your control, he says.

But he emphasizes that responsible management of your health comes with limits, like avoiding experimental therapies. A group of people have decided to try some expensive and dangerous interventions, but there is zero evidence that any of these are going to help them live longer, he says. The problem, according to Verdin, is that the results of aging interventions in mouse trials can look very promising but rarely translate to success in humans. Theres a huge delta between the health of a stressed lab mouse and an optimally healthy mouse, Verdin says. So when you treat lab mice with longevity therapeutics, you see an outsized result that doesnt at all guarantee the same result in humans.

On the other hand, Verdin tells Robb Report, there are definitely new protocols worth getting excited about. Take, for instance, rapalogs, a class of drugs that interact with a protein called mTOR, which serves as a linchpin for multiple critical biological processes, including cell growth and metabolism. Rapalog drugs tamp down mTOR, possibly preventing age-related diseases such as diabetes, stroke and some cancers. The drug rapamycin, the most heavily studied formula, was approved in the US in 1999 to help prevent organ-transplant rejection. Last year the medical journal Aging published a rapturous opinion piece by oncologist Mikhail Blagosklonny in which he made the case that rapamycinin small or intermittent dosesis effective as a preventive treatment to ward off diseases of aging, and that, in the elderly, not taking rapamycin may be even more dangerous than smoking.

Eric VerdinJim Hughes Photography

Later this year, a biotech firm called resTORbio, which was spun out of the Swiss-based Big Pharma company Novartis in 2017, is expected to seek FDA approval for its rapalog RTB101, which clinical trials have shown to slow age-related decline of the immune system and improve immune response in elderly people by more than 20 percent, a key factor in protecting vulnerable aging populations from disease. (It is currently in trials on elderly patients with Covid-19.) This is the furthest-along program of anything in the aging field, Joan Mannick, cofounder and chief medical officer of resTORbio, told MIT Technology Review last year. If health authorities approve this drug well have a product for people to prevent age-related diseases. Not just in our lifetime, but in, you know, a few years.

One of the many effects of rapamycin is that it mimics the mechanisms of calorie restriction. As Verdins lab and others have shown, fasting provides a number of anti-aging benefits, including insulin regulation, reduced inflammation and, to put it colloquially, clearing out the gunky by-products of metabolismpart of the reason Twitter CEO Jack Dorsey and other tech titans eat just a few meals per week. For lesser mortals, fasting is extremely hard to commit to and not much fun, hence the huge interest in calorie-restriction mimetics like rapamycin, which provide all the benefits without the downer not-eating part.

Of all the calorie-restriction mimetics, the one sparking the most excitement among longevity researchers is already on the market: metformin, a decades-old diabetes drug. Metformin became a part of the Silicon Valley health regimen several years ago after an epidemiological study showed that Type 2 diabetics who took the drug lived longer than non-diabetics who didnt. Just about everyone in the longevity industry takes metformin, Verdin tells me. He takes it himself, and nearly everybody I interviewed is taking or has taken it, too.

In April, Nir Barzilai, the renowned endocrinologist who spearheaded research on the anti-aging properties of metformin, announced in an opinion piece he co-authored in the journal Cell Metabolism that his lab is launching a large clinical trial to investigate the anti-aging effects of the drug on non-diabetic populations. Barzilais goal is to prove to the FDA that aging itselfrather than conditions associated with it, like Alzheimers and arthritiscan be targeted as a disease. If Barzilai is successful and the FDA approves aging as a treatment indication, the process of bringing longevity therapies to market would accelerate rapidly.

Just as the FDA was able to move faster to bring Covid-19 therapies to market this year, we will reach a tipping point when public opinion pushes the FDA to approve aging as an indication, and the longevity-research field will make leaps as a result, Mellon says. He has contributed funding to Barzilais metformin research, which he believes will be instrumental in proving that there are compounds that can extend human life across the board.

The fact of the matter is that the US has the best regulatory system for new drug development in the world, Mellon says. Were in the first era ever when humans can be bioengineered to live longer. And in 10 years, well have solutions that are even better than today. Just wait, its coming.

Liz Parrish

Jim Mellon

Diet:Vegetarian.Mindfulness practice:Nightly meditation.

Exercise regimen:30 minutes of cardio and 10 minutes of weights,five days a week.

Anti-aging Rx:Regenerative gene therapies. Im certain most peoplewill take them in the next couple decades.

180th-birthday wish:Solving another critical issue.

Sleep routine:7.5 hours plus a 30-minute nap; in bed by 9 p.m.

Vitamins/supplements/ prescription meds:Vitamins D and B12, metformin.

Exercise regimen:Walk or run minimum 10,000 steps a day;weights three times week.

Anti-aging Rx:Green tea.

100th-birthday wish:Another 25 years.

Dave Asprey

Jim Hughes Photography

180th-birthday wish:Either a cruise to Mars or a 1970 Mustang Fastback,which by then will be 210 years old!

Sleep Routine:Avoid: coffee after 2 p.m., heavy workouts after 6 p.m.,alcohol during the week and heavy eating in the evening.

Vitamins/supplements:Vitamin D, omega fatty acids, NMN, citrus bioflavonoidcomplex, fiber supplement, prebiotic supplement.

Diet:Fasting-mimicking diet once every four to six months;roughly 16:8 intermittent fasting at other times.

Mindfulness practice:Daily meditation.

Anti-aging Rx:I love cooking and eating, so I do not restrict foodon the weekend. Happiness with friends and family is thesurest path to longevity.

100th-birthday wish:A bike tour across the US, from coast to coast.

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Why Silicon Valley Execs Are Investing Billions to Stay Young - Robb Report

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Poseida Therapeutics sets terms for upcoming IPO, aims to raise $150M for cancer treatments – The San Diego Union-Tribune

By daniellenierenberg

Poseida Therapeutics, which is developing targeted treatments for blood-based and other cancers, set the terms for its initial public stock offering expected this week, where it is seeking to raise $150 million.

The San Diego-based company has one drug advancing to Phase 2 clinical trials for multiple myeloma, a type of cancer that develops in certain cells in the bone marrow.

The company expects to file for investigational new drug authorization with the U.S. Food and Drug Administration for its myeloma treatment later this year.

It also is developing other cancer therapies, including treatments for solid tumors and prostate cancer.

Poseida Therapeutics looks to become the third San Diego life science company to go public in the past two months, joining Progenity and Avidity Biosciences. Its stock offering highlights that investor appetite for new biotech companies remains strong in the midst of stock market turbulence from the coronavirus pandemic.

At the end of March, the company employed 149 workers, including 86 with advanced college degrees.

Since its inception, the company has raised $334 million from life sciences institutional investors who support its drug development efforts, including $75 million from Swiss pharmaceutical giant Novartis.

Poseida set the price for its initial public stock offering at $14 to $16 per share. It plans to trade under the ticker symbol PSTX on the Nasdaq exchange. If its shares get out at the midpoint of that range, Poseida Therapeutics would achieve a market value of $890 million.

Founded in 2015, Poseida Therapeutics is making its own version of what are called CAR T cells immune cells genetically engineered to fight cancers. It is developing CAR T cell treatments made from cancer patients own cells.

The process produces stem cell memory T cells. These T cells stick around, both replenishing their population and creating more differentiated group of T cells to attack cancers. They can potentially resume activity if the cancer recurs. This persistence makes it possible to produce the activity needed to eradicate tumors, which up to this point has been beyond the reach of this type of therapy.

The company has its roots in Transposagen Biopharmaceuticals, which founder Eric Ostertag ran for 13 years. Poseida was spun out to pursue gene engineering technologies.

Other members of the companys management teams have worked in executive roles at San Diego biotech firms including Amylin Pharmaceuticals, Halozyme Therapeutics and Mirati Therapeutics.

In addition to Novartis, additional investors include Adage Capital, Aisling Capital, Boxer Capital, Fidelity, Longitude Capital, Malin Corp., Millennium Capital, Pentwater Capital, Perceptive Advisors, Schonfeld and Vivo Capital.

Bank of America Securities, Piper Sandler and William Blair are joint underwriters on the initial public stock offering.

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Poseida Therapeutics sets terms for upcoming IPO, aims to raise $150M for cancer treatments - The San Diego Union-Tribune

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FDA Approves Merck’s KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -…

By daniellenierenberg

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) compared with chemotherapy, the current standard of care. In the study, treatment with KEYTRUDA also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months [95% CI, 5.4-32.4] versus 8.2 months [95% CI, 6.1-10.2]).

Todays approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed KEYTRUDA monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

This approval was granted less than one month following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program. This review also was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. For this application, a modified Project Orbis was undertaken, and the FDA is collaborating with the Australian Therapeutic Goods Administration, Health Canada and Swissmedic on their ongoing review of the application.

Patients with unresectable or metastatic MSI-H colorectal cancer have historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options, said Luis A. Diaz, M.D., head of the division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. In patients who were treated with KEYTRUDA and responded (n=67) in the KEYNOTE-177 trial, 43% of patients experienced a duration of response lasting two years or longer. This approval helps address the unmet need to provide a new monotherapy treatment option for patients.

Data Supporting the Approval

The approval was based on data from KEYNOTE-177 (NCT02563002), a multi-center, randomized, open-label, active-controlled trial that enrolled 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. Microsatellite instability (MSI) or mismatch repair (MMR) tumor status was determined locally using polymerase chain reaction or immunohistochemistry, respectively. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible.

Patients were randomized 1:1 to receive KEYTRUDA 200 mg intravenously every three weeks or investigators choice of the following chemotherapy regimens given intravenously every two weeks:

Treatment with KEYTRUDA or chemotherapy continued until Response Evaluation Criteria in Solid Tumors (RECIST) v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. Patients treated with KEYTRUDA without disease progression could be treated for up to 24 months. Assessment of tumor status was performed every nine weeks. Patients randomized to chemotherapy were offered KEYTRUDA at the time of disease progression. The main efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, and overall survival (OS). Additional efficacy outcome measures were objective response rate (ORR) and duration of response (DOR).

Patients were enrolled and randomized to KEYTRUDA (n=153) or chemotherapy (n=154). The baseline characteristics of these 307 patients were: median age of 63 years (range, 24 to 93), 47% age 65 or older; 50% male; 75% White and 16% Asian; 52% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, and 48% had an ECOG PS of 1; and 27% received prior adjuvant or neoadjuvant chemotherapy. Among the 154 patients randomized to receive chemotherapy, 143 received chemotherapy per the protocol. Of these 143 patients, 56% received mFOLFOX6, 44% received FOLFIRI, 70% received bevacizumab plus mFOLFOX6 or FOLFIRI, and 11% received cetuximab plus mFOLFOX6 or FOLFIRI. The median follow-up time was 27.6 months (range, 0.2 to 48.3 months).

In this study, KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) and showed a median PFS of 16.5 months (95% CI, 5.4-32.4) compared with 8.2 months (95% CI, 6.1-10.2) for patients treated with chemotherapy. For PFS, in the KEYTRUDA arm, there were 82 patients (54%) with an event versus 113 patients (73%) in the chemotherapy arm. At the time of the PFS analysis, the OS data were not mature (66% of the required number of events for the OS final analysis). For patients treated with KEYTRUDA, the ORR was 44% (95% CI, 35.8-52.0), with a complete response rate of 11% and a partial response rate of 33%, and for patients treated with chemotherapy, the ORR was 33% (95% CI, 25.8-41.1), with a complete response rate of 4% and a partial response rate of 29%. Median DOR was not reached (range, 2.3+ to 41.4+) with KEYTRUDA versus 10.6 months (range, 2.8 to 37.5+) with chemotherapy. Based on 67 patients with a response in the KEYTRUDA arm and 51 patients with a response in the chemotherapy arm, 75% in the KEYTRUDA arm had a duration of response greater than or equal to 12 months versus 37% in the chemotherapy arm, and 43% in the KEYTRUDA arm had a duration of response greater than or equal to 24 months versus 18% in the chemotherapy arm.

Among the 153 patients with MSI-H or dMMR colorectal cancer treated with KEYTRUDA, the median duration of exposure to KEYTRUDA was 11.1 months (range, 1 day to 30.6 months). Adverse reactions occurring in patients with MSI-H or dMMR colorectal cancer were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer treated with KEYTRUDA as a single agent.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High (TMB-H)

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

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FDA Approves Merck's KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -...

categoriaCardiac Stem Cells commentoComments Off on FDA Approves Merck’s KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -… dataJune 29th, 2020
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The Latest Technological Innovations in Orthopedic Surgery 2020 Technology – IMC Grupo

By daniellenierenberg

Technology across the world is improving and innovatingwith time. Over the years, man-managed labor has almost finished from themarket and more and more technological and scientific gadgets are taking placemaking human labor more effective, efficient, and precise.

Medical science has also taken a lot of advantage fromthis scientific advancement therefore, we can say that doctors are making fulluse of science and technology and the world of medicine has evolved quiterapidly.

Orthopedic hospitalshave also seena remarkable transformation over time and the days when a regular orthopedicclinic only comprised of a few tools and a bad. The launch of innovativetechnologies, biologics, and hybrid items into the orthopedic industry isincreasingly growing.

Any of these emerging inventions gain regulatory approvalby showing significant equivalence to the US System of the Food and DrugAdministration (FDA) 510(k).

Surgeons play a key role in the implementation ofemerging technology to patients and will play a leading role in supportinghealthy, efficient, adequate, and cost-effective treatment, particularly forsurgical procedures. Surgeons will track and record the health results andadverse effects of their patients utilizing modern technologies and ensure thatthe new technology works as expected.

Ortho-biologics utilizes the regenerative ability ofcells in the human body. Ortho-biologics are created from compounds naturallypresent in the body which are used to facilitate the recovery of fracturedbones which injured joints, ligaments, and tendons.

These involve bone graft, growth factors, stem cells,platelet-infused plasma, autologous blood, and autologous controlled serum. Themesenchymal stem cells (MSCs) contained in the bone marrow has been shown to besuccessful in the production of the appropriate tissues.

Result in Orthopedic Procedures

Recent advances in this area, including growth factor andstem cell therapies, may contribute to faster recovery. One breakthrough isdrug-free bone grafts, which may be used to cure conditions such as orthopedicsurgery. Clinical trials have demonstrated that growth factors can improve thehealing cycle.

Stem cells will continually self-regenerate and transforminto either form of cell, providing an unmatched source of regenerativemedicine technology. Definitions of musculoskeletal procedures utilizing stemcells are listed below.

Biotechnology firms began utilizing orthopedic stemcells. For starters, BioTime works on stem cell therapies for age-relateddegenerative diseases, IntelliCell BioSciences on adipose-derived stem cellsfor orthopedic conditions, and Bio-Tissues on Ortho-biological treatments forcartilage defects.

Orthopedic procedures using robots are less intrusive anddeliver reproducible accuracy, resulting in shorter hospital stays and quickerrecovery times. The Swiss clinic, La Source, recorded a decline in averagehospitalization from 10 to 6 days with the usage of surgical robots.Nevertheless, this technology is also costly to develop, so solid,evidence-based trials are required to prove that robotic technology contributesto improved outcomes.

The Da Vinci Surgical Method became the first U.S. Food andDrug Administration (FDA)-an authorized robotic surgery program in 2000. Morebusinesses are investing in this technology to enhance navigation duringservice or to receive 3-D scans that aid in the design of custom joints.

Organizations that are interested, in robotics areinclined towards the following technological masterpieces:

Several modern surgical techniques are enhancing theresults. These involve motion-preservation methods, minimally intrusive surgery,tissue-guided surgery, and cement-free joint repair.

Motion recovery strategies require partial or completedisk removal and the usage of active stability systems and interspinous spacersthat do not impair versatility.

Minimally intrusive procedures involve the use ofendoscopes, tubular retractors, and computer-aided guidance devices, allowingan incision of just 2 cm instead of 12 cm in conventional therapies. Minimallyinvasive treatments are gaining popularity in joint and hip replacement and spinalsurgery.

Smart devices provide built-in sensors to offer real-timetracking and post-operative evaluation details to surgeons for better patientsafety across the clinical process. Such implants have the ability to minimizeperiprosthetic infection, which is an increasing orthopedic issue.Sensor-enabled innovations also presented health care professionals with arange of innovative, cost-effective goods.

Companies working in this field include:

3-D orthopedic printing is gaining traction in themanufacture of personalized braces, surgical equipment, and orthotics from arange of materials. 3-D printing technology cuts operating times, saves energy,increases the long-term reliability of the implant, and enhances the healtheffects of surgical procedures. 3-D printing technologies of orthopedics areinclusive of:

Companies investing in 3-D Orthopedic Printing

Medical science has taken a huge turn with the introduction of technology. The orthopedic industry has also transformed to a huge extent making sure that the specialists and surgeons are able to treat and operate on their patients without any hassle. Almost all the orthopedic hospitals are equipped with high-end gadgets and tools to assist the doctor.

Even though the technology has evolved greatly since thefield of medicine was invented, it is important to understand that this is justa beginning and there are many more things to come in the future.

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The Latest Technological Innovations in Orthopedic Surgery 2020 Technology - IMC Grupo

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Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 – JD Supra

By daniellenierenberg

Updated: May 25, 2018:

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Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 - JD Supra

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‘A key pillar of the future’: Givaudan tips growth for ingredients developed with green biotech – CosmeticsDesign-Asia.com

By daniellenierenberg

Mathais Fleury, Givaudans global category manager of biotech actives, told CosmeticsDesign-Asia that leveraging on green biotechnology would allow companies to find solutions to consumers desire for products that are natural, sustainable and high-performing.

Green Biotech truly is a key pillar of the future. Consumers are looking for more naturality while protecting nature a difficult challenge, made possible by biotech along with a high level of innovation, said Fleury.

Most recently, the Swiss company collaborated with South Korean biotech company BIO-FD&C to tackle two frustrating beauty concerns by leveraging on green biotechnology.

It recently unveiled two actives, K-phyto [SC] Camellia and K-phyto [PP] GHK, which were developed to address dry scalp and oily skin respectively.

This exclusive partnership with Bio FD&C leverages the untapped power of plants through stem cell cultures and unique phytopeptides. It allows our experts to offer innovative natural and reliable solutions for hair and skin care issues such as dry scalp and oily skin, while protecting our planet, said Fleury.

K-phyto [SC] Camellia is an ingredient obtained from camellia phytoplacenta cells culture.

According to the company, the active can increase the scalp moisture content by 13.8%. This reinforces the epidermal cohesion of the scalp keratinocytes and reduces dry flakes and dandruff down by 33.6%.

It also was observed soothe the scalp by being able to reduce erythema down 6.6%.

According to Givaudan, having botanical claims with popular ingredients such as camellia, more commonly known as Tsubaki in the region, can drive hair care product launches by 70% in APAC.

The second ingredient, K-phyto [PP] GHK, is a molecule that combines botanicals and peptides to act on the mechanisms of sebum production.

Clinical studies have shown facial sebum production reduction by 35.5% in two weeks and 67.5% in one month.

Oily skin is a major claim requested by the market, specifically in APAC. Clinical results with the phytopeptide we've chosen to bring to market are outstanding and we definitely believe this could be a game changer, said Fluery.

The Swiss firm believes that the two actives showed a lot of promise for the global market.

Our partner was already doing a very good job in its local market, but we want to leverage our access to different places over the world to highlight its expertise and know-how. This collaboration is a real opportunity to bring innovative ingredients to consumers globally, and that's why we'll offer these products to our partners all over the world, said Fleury.

Additionally, these ingredients are aligned with the ideals of clean beauty, one of the most talked-about trends in the beauty market right now.

The two technologies that we've identified in Bio FD&C portfolio are a perfect answer to this need of clean beauty combined with performance, said Fluery.

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'A key pillar of the future': Givaudan tips growth for ingredients developed with green biotech - CosmeticsDesign-Asia.com

categoriaSkin Stem Cells commentoComments Off on ‘A key pillar of the future’: Givaudan tips growth for ingredients developed with green biotech – CosmeticsDesign-Asia.com dataApril 28th, 2020
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