CALQUENCE (acalabrutinib) is now available for adult patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia

MISSISSAUGA, ON, Jan. 8, 2020 /CNW/ - AstraZeneca Canada today announced that Health Canada has approved Calquence (acalabrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia (CLL), as monotherapy or in combination with obinutuzumab in the first-line setting, and as monotherapy for relapsed/refractory (r/r) disease.1

CLL is the most common type of leukemia in adults, accounting for 44 per cent of all cases in Canada.2 Morethan 2,200 people in Canada are diagnosed with the disease each year and more than 600 will die from it.3,4 Despite advancements in the treatment of CLL, there is still no cure for the disease and even after successful initial treatment, some patients may relapse, leaving them in need of further innovation.

"CLL is most often diagnosed when patients are more than 60 years old, at a time when they are already dealing with other health conditions related to aging and are trying to maintain the best quality of life," says Antonella Rizza, CEO of Lymphoma Canada. "Today's announcement offers Canadians living with CLL an important new option for this incurable but treatable disease."'

The Canadian approval was granted under Project Orbis, a new international health authority collaboration which provides a framework for simultaneous submission and review of oncology products among international partners.5Under this collaboration, Health Canada, the U.S. FDA, and the Australian Therapeutic Goods Administration (TGA) collectively reviewed the application for Calquence, making it the second treatment approved as part of the program and the first in hematology.

"In the last several years, we've been moving away from traditional chemotherapies to more targeted therapies for CLL." said Dr. Carolyn Owen, Alberta Health Services, Calgary. "Health Canada's approval of acalabrutinib provides a new effective and well tolerated treatment option for CLL patients and improves their treatment options."

The Health Canada approval of Calquence was based on positive interim data from two Phase III clinical trials, ELEVATE-TN and ASCEND.6,7The ELEVATE-TN trial evaluated the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. The ASCEND trial evaluated the efficacy of Calquence in previously treated patients with CLL.Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.1

About chronic lymphocytic leukemia (CLL)Chronic lymphocytic leukemia is the most common type of leukemia in adults, which begins in the bone marrow, and progresses slowly.8 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.9 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.9This could result in anaemia, infection and bleeding.9B-cell receptor signalling through BTK is one of the essential growth pathways for CLL. Many people with CLL do not have any symptoms upon diagnosis, and the disease is often found in blood tests for unrelated health problems.10

AboutCalquenceCalquence(acalabrutinib; previously known as ACP-196) is a selective inhibitor of Bruton's tyrosine kinase (BTK).1Calquencebinds covalently to BTK, thereby inhibiting its activity, and has demonstrated this with minimal interactions with other immune cells in pre-clinical studies.1,6,7In B cells, BTK signaling results in activation of pathways necessary for B cell proliferation, trafficking, chemotaxis and adhesion.1 The recommended dose ofCalquenceis one 100mg capsule taken orally twice daily (approximately 12 hours apart), until disease progression or unacceptable toxicity.1Calquencemay be taken with or without food.1

About AstraZenecaAstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at http://www.astrazeneca.ca.

References

SOURCE AstraZeneca Canada Inc.

For further information: AstraZeneca Corporate Communications, [emailprotected]; Hibaq Ali, Weber Shandwick Canada, [emailprotected] / tel: 416-642-7915

http://www.astrazeneca.ca

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New Treatment Approved in Canada for Most Common Type of Leukemia - Canada NewsWire

Bone Marrow Stem Cells Comments Off on New Treatment Approved in Canada for Most Common Type of Leukemia – Canada NewsWire | January 8th, 2020

(MENAFN - Fior Markets)

Spearheaded by researchers at Baylor College of Medicine divulges a contemporary mechanism that donates to adult bone conservation and restores and unfurls the possibility of advancing the therapeutic plan of action for enhancing bone healing.

Corresponding author Dr. Dongsu Park professor of molecular and human genetics said that adult bone repairs depend on the setting off of bone stem cells which yet remains deficiently distinguished. Bone stem cells have been discovered both in the bone marrow interior of the bone and also in the periosteum the exterior layer of the tissue that wraps the bone. Former studies have portrayed that these two communities of stem cell albeit they apportion various characteristics also have distinctive functions and particular regulatory processes.

Of the two periosteal steam cells are the minimalistcomprehended. It is known that they constitute a heterogeneous population ofcells that can bestow to bone density, molding and rupture restoration,however, scientists had not been able to discern between varied subtypes of thebone stem cell to scrutinize how their varied purposes are controlled.

In the present study Park and his colleagues advanced aprocedure to recognize varied subpopulations of periosteal stem cells expoundtheir benefaction to bone fracture restoration in animate mouse models andrecognize particular components that control their migration and multiplicationunder psychological circumstances.

The researchers found particular trademarks for periosteal stem cells in mouse models. The trademarks recognized a definite subset of stem cells that donates to long-lasting adult bone resurrection.

MENAFN07012020007010660ID1099519082

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Contemporary Bone Alleviates Mechanisms Have Prospective Therapeutic Applications - MENAFN.COM

Bone Marrow Stem Cells Comments Off on Contemporary Bone Alleviates Mechanisms Have Prospective Therapeutic Applications – MENAFN.COM | January 7th, 2020

SUZHOU, Chinaand SHANGHAI, Jan. 7, 2020 /PRNewswire/ -- Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell therapy company, today announced the initiation of an investigational study of GC027, the first product candidate developed using TruUCAR to treat relapsed or refractory (R/R) T-cell malignancies.

T-cell acute lymphoblastic leukemia or T-ALL is an aggressive form of ALL, which affects white blood cells and the bone marrows ability to generate healthy blood cells. About 15-20% of people with ALL have T-ALL. While T-ALL is treatable by chemotherapy and stem cell transplant, around 75% of patients will relapse within two years[1]. T-cell lymphoblastic lymphoma (T-LBL) is another devastating T-cell malignancies. For patients who develop R/R T-ALL or T-LBL, there are few options for treatment.

Autologus CAR-T therapies rely on patients' own T cells, which have been affected by prior therapies; thus, cell quality as well as efficacy remains questionable. Allogenic CAR-T therapies made of healthy donors' T cells would be characterized as being of consistently good quality with the potential to improve efficacy. Unlike autologous CAR-T cells, allogeneic CAR-T cells can be made as off-the-shelf product which means patients do not have to wait for lengthy production time. Furthermore, the cost of production can be significantly lower. Allogenic CAR-T therapies also provide a vital treatment option for patients with viral infections and/or other conditions prohibiting access to autologous cell therapies.

TruUCARbased GC027 is designed to meet the above unmet needs. Its cells are made of T cells from healthy donors, genetically edited and inserted with chimeric antigen receptor (CAR) ex vivo, which can specifically bind to and eliminate target T malignant cells. Different from industry leaders' off-the-shelf CAR-T design, Gracell's proprietary and patented TruUCAR technology requires no co-administration of anti-CD52, a cytotoxic agent for ablating cancerous cells while inducing long term immune depletion in the patient.Instead, GC027 utilizes CRISPRgenome editing strategy that is expected to avoid graft-versus-host disease (GvHD) as well as graft rejection caused by the patients' immune system.

The prudent preclinical studies provide substantial evidence to trigger GC027 moving into a non-IND(investigational new drug)clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of GC027 therapy in patients suffering from relapsed and refractory T lymphocyte malignancies.

TruUCAR is another technological breakthrough developed by Gracell following the recent announcement of FasTCAR technology and products. It enables producing off-the-shelf CAR-T cells from healthy MHC (major histocompatibility complex) mismatched donors with a large number of doses readily to be dispatched to patients in need.

"Launch of the investigational GC027 study as the first-of-its-kind therapy marks another significant milestone for Gracell," said Dr. William CAO, Founder and CEO of Gracell. "Once the concept is well-proved with solid evidence for safety and efficacy, we will immediately deploy development of a series of TruUCAR products for other medical unmet needs, including B cell malignancies."

About GC027

GC027 is an investigational, off-the-shelf CAR-T cell therapy for T cell malignancies, derived from healthy donors. The use of healthy donor's cells are preferential to a patient's own with potential to improve efficacy, reduce production time, and lower cost of goods.

About T-ALL

T lymphoblastic leukemia (T-ALL) is an aggressive form of T cell malignancies, with a diffuse invasion of bone marrow and peripheral blood. In 2015, ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide. T-ALL compromises about 15%-20% children and adults[1].Current standard therapies for T-ALL are chemotherapies and stem cell transplantation. A large portion of these patients will experience relapse within two years following treatment by conventional therapies.

About T-LBL

T lymphoblastic lymphoma (T-LBL) is an aggressive form of T cell malignancies, with rare lymphoproliferative neoplasm of mature T cells caused by infection with the retrovirus human T lymphotropic virus. T-LBL compromises about 2% of adult non-Hodgkin's lymphoma (NHL) and 30% of pediatric NHL patients[2]. Five-year overall survival is only 14% in adults.Although first-line treatment using cytotoxic combination chemotherapy can achieve 70% ORR, nearly 90% of patients relapse, often within months of completing chemotherapy.

About Gracell

Gracell Biotechnologies Co., Ltd. ("Gracell") is a clinical-stage biopharma company, committed to developing highly reliable and affordable cell gene therapies for cancer. Gracell is dedicated to resolving the remaining challenges in CAR-T, such as high production costs, lengthy manufacturing process, lack of off-the-shelf products, and inefficacy against solid tumors. Led by a group of world-class scientists, Gracell is advancing FasTCAR, TruUCAR (off-the-shelf CAR), Dual CAR and Enhanced CAR-T cell therapies for leukemia, lymphoma, myeloma, and solid tumors.

CONTACT:

[1]Pediatric hematologic Malignancies: T-cell acute lymphoblastic Leukemia, Hematology 2016

[2]Clinical Review: Adult T-cell Leukemia/lymphoma, Journal ofOncology Practice 2017

SOURCE Gracell

http://www.gracellbio.com

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Gracell Initiates Investigational Study of the Technological Breakthrough TruUCAR Therapy for Relapsed or Refractory T-cell Malignancies - PRNewswire

Bone Marrow Stem Cells Comments Off on Gracell Initiates Investigational Study of the Technological Breakthrough TruUCAR Therapy for Relapsed or Refractory T-cell Malignancies – PRNewswire | January 7th, 2020

Fourteen charities based in London have won a 1,000 festive boost thanks to nominations from the public.

The charities were nominated to win a share of 120,000 as part of specialist insurer Ecclesiasticals annual 12 days of giving Christmas campaign.

Anthony Nolan, which helps to save lives by matching individuals willing to donate their blood stem cells or bone marrow to people with blood cancer and blood disorders, and Shakespeare Schools Foundation, which helps thousands of young people from across the UK become better at teamwork, more confident and more ambitious (see notes for full list1), are among the local charities set to benefit from the money, following overwhelming public support in the area.

More than 120,000 people around the UK nominated a cause close to their heart, with over 5,000 charitable causes up and down the country receiving votes. The 120 winning charities were picked at random from those nominated.

The full list of the 120 charity winners is available to view online at http://www.ecclesiastical.com/12days

Thanking supporters in London, Mark Hews, group chief executive at Ecclesiastical, said: Here at Ecclesiastical, our core purpose is to contribute to the greater good of society, so charitable giving is at the heart of our business. We know that 1,000 can make a huge difference to the incredible work that charities do and were looking forward to seeing how this festive financial boost will change lives for the better.

Last year, Ecclesiastical launched its second Impact Report to celebrate some of the many good causes it has helped.

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London charities scoop share of 120000 festive financial boost - London Post

Bone Marrow Stem Cells Comments Off on London charities scoop share of 120000 festive financial boost – London Post | January 7th, 2020

NEW YORK, Jan. 7, 2020 /PRNewswire/ --

Report Includes: - An overview of recent advances in stem cell therapies and coverage of potential stem cells used for regenerative advanced therapies

Read the full report: https://www.reportlinker.com/p05835679/?utm_source=PRN

- Discussion on role of genomic and epigenomics manipulations in generating safe and effective treatment options - Identification of autologous and allogeneic cells and their usage in creating advanced therapy medical products (ATMPs) - Information on 3D cell culture and discussion on advances in gene editing and gene programming techniques such as CRIPSR/Cas9, TALEN, and ZINC fingers - Insights into commercial and regulatory landscape, and evaluation of challenges and opportunities for developing autologous and allogenic "off the shelf" solutions

Summary Stem cells are unique in their ability to divide and develop into different cell types that form tissues and organs in the body during development and growth.The stem cell's role is to repair impaired or depleted cells, tissues and organs in the body that are damaged by disease, injury, or normal wear and tear.

Stem cells are found in every organ, but are most abundant in bone marrow, where they help to restore the blood and immune system.

Stem cells may be derived from various sources, including - - Adult stem cells (ASCs): Derived from tissue after birth, these include bone marrow, brain, peripheral blood, skeletal muscle, skin, teeth, heat, gut, liver, ovarian epithelium and testis, as well as umbilical cord stem cells and blood. These cells are currently most widely used for cellbased therapies. Hematopoietic stem cells (HSCs), which are derived from bone marrow, can give rise to red blood cells, white blood cells and platelets, whereas mesenchymal stem cells (MSCs) are derived from the stroma and give rise to non-blood forming cells and tissues. - Human embryonic stem cells (hESCs): Derived from embryos, these include stems cell lines, aborted embryos or from miscarriages, unused in vitro fertilized embryos and cloned embryos. There are currently no clinically approved treatments for embryonic stem cells. - Inducible pluripotent stem cell (iPSCs): These are stem cells generated in the laboratory by reprogramming adult cells that have already differentiated into specific cells, such as liver cells. They are used either for research purposes (e.g., experimental medicine testing toxicity of new drugs) or are under research for potential future clinical use.

Read the full report: https://www.reportlinker.com/p05835679/?utm_source=PRN

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Highs and Lows of Stem Cell Therapies: Off- The-Shelf Solutions - P&T Community

Skin Stem Cells Comments Off on Highs and Lows of Stem Cell Therapies: Off- The-Shelf Solutions – P&T Community | January 7th, 2020

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The start of a new year is the perfect time to prioritize self-care and set health and wellness goals, so make 2020 your happiest yet with a new, enhanced version of you. Use this guide to find the doctors, therapists and practitioners that can help you look and feel your best.

When diet and exercise just wont provide the results youre looking for, visit Skiin Anti-Aging Lounge. They offer the only procedure that builds muscle. EMSCULPT has been proven safe and effective by the most reputable scientific methods. The procedure induces strong muscle contractions with Hifem (high-intensity electromagnetic) technology not achievable through voluntary contractions. This builds muscle and creates a sculpted, toned physique. Other services like CoolSculpting and Exilis also help clients reshape their bodies through nonsurgical, noninvasive methods. Skiin is the first and only CoolSculpting advanced education center in the nation. Another first: Exilis is the first and only device to combine radio frequency and ultrasound to tighten skin through heating and cooling.

Your face is the first place to show signs of aging, but there is a way to take back those years. Dr. John Yousif has received several awards for his research in facial aging. He has been practicing plastic and cosmetic surgery for over 30 years and has even pioneered new techniques like the Gortex Midface Lift and the Hyoid Suspension Neck Lift. At both Sier Medi-Spa and Ascension in Mequon, he offers surgical and nonsurgical procedures to reverse the signs of aging. All of the types of facelifts offered are long-lasting and natural looking, leaving clients feeling like a younger version of themselves.

RELATED Wonderful World of Weddings

Aqua, under the direction of Dr. Christopher Hussussian, is a full-service salon, spa and med spa offering a wide range of services in a luxurious setting on Pewaukee Lake. Whether you are hoping to change the way you look or feel or both Aqua has a solution to enhance your skin and hair for both body and face. New services for the new year include hair restoration for both men and women using PRP (platelet-rich plasma) with biotin and a new weight-loss program using the HCG hormone. They also offer advanced laser hair removal, Clear Lift skin tightening, ThermiVa and CoolSculpting, a popular nonsurgical fat cell reduction with lasting results. A consultation can help you decide what services would work best to achieve a healthier, happier version of yourself.

Serving the Lake Country area, Dr. Tom Stamas is helping people put their best face forward, one smile at a time. He specializes in smile design, a full dental restoration and reconstruction for those suffering from tooth damage or loss, or for those looking to fix crooked, worn or yellowed teeth. During your personalized consultation, Stamas and his team will help you select which treatments will bring your smile to life. Dental treatments like bridges, dental implants, crowns and state-of-the-art diagnostic tools are all available to restore the health, function and appearance of your smile. Youll feel good about the natural-looking results, and your self-esteem will get a boost too.

What if you could use undesired fat from your belly to get rid of the bags under your eyes? Sounds too good to be true, right? Anew Skin and Wellness has a procedure that is done right in the office with long lasting results. The nano-fat transfer removes a small amount of fat with micro liposuction. That fat is harvested for re-injection to the appropriate areas of the face, neck, earlobes, hands and thighs. It can also be used to plump thin lips, smooth cellulite and scars and restore skin elasticity. The nano-fat transfer is safe, effective, economical and helps clients look their best. The in-office procedure provides long-lasting results because the bodys stem cells can turn the aging skin into new, rejuvenated skin. Its the natural way to tighten and smooth skin, allowing you to turn back the clock without a surgical face- or neck-lift.

RELATED Where Should You Brunch this Weekend? We've Got 9 Suggestions

Dr. Arvind Ahuja has provided neurosurgical and endovascular care in southeastern Wisconsin for more than 20 years for brain, spine, artery and peripheral nerve conditions. Whether patients come to Neurosurgery and Endovascular Associates for neck and/or arm pain, back and/or leg pain or headache, the first step is always diagnostic testing to determine the cause of the pain, rather than just treating the symptoms. Often through treatments like medication, steroid injections, physical therapies and if need be surgery, patients achieve improved functioning and long-term relief. Ahujas specialized training in the nervous system is incredibly effective in treating spinal conditions, and his treatments give patients the opportunity to live a happier and morefunctional life.

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How These Practitioners Can Help with New Year, New You Goals - Milwaukee Magazine

Skin Stem Cells Comments Off on How These Practitioners Can Help with New Year, New You Goals – Milwaukee Magazine | January 7th, 2020

Welcome to Try Before You Buy, a monthly series where we talk about the pricey beauty products and in-office treatments that are getting major buzz and give our honest feedback. This month, our Senior Beauty & Fashion Editor, Pia Velasco, talks about theAugustinus Bader cream that has changed her skin.

As a beauty editor, Ive tried hundreds (and maybe even thousands) of skincare products since starting my career seven years ago. There have been creams that promise to give me skin as soft as babys bum, serums that pledge to erase all signs of dark spots, face masks that swear theyll make my skin so radiant that itll blind my enemiesand guess what, most of them fell through on their promises. As such, Ive become skeptical when a brand tells me that their product is life-changing and that there isnt anything like it on the market. So when I met Professor Augustinus Bader, the director of the Applied Stem Cell Biology and Cell Technology at the University of Leipzig in Germany, earlier this year and he and his team told me about his epigenetic skincare line that changes the skin to the point of altering DNA, I have to admit that I did mentally raise an eyebrow.

However, I had heard about epigenetic skincare before and was fascinated by the science behind it. Essentially, epigenetics refers to the naturally occurring biological modification process of the DNA thats influenced by the environment and lifestyle patterns. For example, if you have a healthy diet and exercise on the regular, your genetic coding will eventually change to be healthier, and youll be able to transfer those healthy genes onto your offspring. Epigenetic skincare is the same conceptif you train your skin cells to be healthy, your skins DNA will change. Needless to say,I was curious to try it, and when a fellow beauty editor friend told me that she stopped using all of her skincare products after trying the Augustinus Bader The Rich Cream, I went from being curious to being eager to try it.

A quick background on my skin. Ive always had acne-prone skin, and because of my medium skin tone, Im also very prone to hyperpigmentation. Most of the skincare products I use target my acne concerns, but I also go ham on texture-refining products in hopes that one day Ill achieve glass-like skin. Im used to looking at ingredients that target specific skincare concerns (salicylic acid for acne, retinol for anti-aging, vitamin C for brightening, etc.), and for the first time, I was using a product that claimed that it would address all my concerns at once. Because of the way epigenetic skincare works, instead of targeting just one skincare concern, the product tells skin cells to be healthy, which in turn helps skin be the best version of itself.I know it sounds too good to be true, and while it may not work for everybody, holy shit it worked wonders for me.

Courtesy of Augustinus Bader

I started testing out the cream the way I approach all my beauty testing, I did a test-drive on half my face. On the left side of my face, I continued to use the products that were already in my arsenal, and on the right side of my face, I used the Augustinus Bader cream and nothing else. After about two weeks I started seeing a shiftmy acne wasnt working up, my skin texture was a lot more smooth, and it just looked overall healthier. I quickly tossed my other products and switched over to using The Rich Creamevery day. After a while, my skin started balancing out and both looked and felt a whole lot better. Now, Im not saying this product is magicbut Im also not saying that its not.

Im currently testing a whole new array of skincare products for the upcoming HelloGiggles Beauty Crush Awards (stay tuned!), and so Ive had to sacrifice the left side of my face to test new products (I switch off between sides). As a result, my skin has started to shift back into its old ways, with a resurgence of blemishes, dark spots, and uneven texture as I test out new formulas. But the right side of my face is still in A+ condition.

Sure, this product is definitely on the pricier side, but its a product that I can say with full confidence that I would actually buy if I wasnt a beauty editor. (Full disclosure: I receive a lot of free products from beauty brands, and Ive only bought about a handful of products with my own money since working in the business.) For me, getting my ideal skin has always been a battle, and Im so happy to have finally found a product that works magic for me, which is why I was excited to learn that the brand recently launched a body cream as well.

Courtesy of Augustinus Bader

Its important to remember that body care requires skincare too, after all, we do have skin on our bodies. The Augustinus Bader body cream fulfills the basic requirement of moisturizing skin, but what makes this anti-aging body product stand out is that it uses its epigenetic technology to target and treat stretch marks and cellulite with continued use. Now, I havent used it long enough to speak to its long-term effects, but I can say that its fast-absorbing formula does make my skin feel baby soft and look way smoother than it did before. Also, Im typically very good about sharing my beauty products with others, but when my boyfriend asked if he could use this cream I may or may not have told him Id put a curse on his ancestors if he dared. Nothing gets in the way of me and my Augustinus Bader products.

Originally posted here:
The viral Augustinus Bader rich cream has completely changed my skin for the better - Yahoo Lifestyle

Skin Stem Cells Comments Off on The viral Augustinus Bader rich cream has completely changed my skin for the better – Yahoo Lifestyle | January 7th, 2020

LONDON--(BUSINESS WIRE)--Technavio has been monitoring the global amniotic membrane market since 2019 and the market is poised to grow by USD 1.48 billion during 2020-2024, progressing at a CAGR of more than 13% during the forecast period. Request a free sample report

Read the 145-page report with TOC on Amniotic Membrane Market Analysis Report by Geography (Asia, Europe, North America, and ROW), Type (Cryopreserved amniotic membrane and Dehydrated amniotic membrane), and the Segment Forecasts, 2020-2024.

https://www.technavio.com/report/amniotic-membrane-market-industry-analysis

The market is driven by the rising demand for biocompatible scaffolds. In addition, the rise in the development of new applications through research is anticipated to boost the growth of the amniotic membrane market.

The rising need for naturally derived materials in tissue scaffolding is increasing the demand for amniotic membranes. This is due to the specialized structure of amniotic membranes that exhibit high biological viability, making them ideal for creating bio-scaffolds. Moreover, the epithelial cells in amniotic membranes have the advantages of stem cells which provide a native environment of cell seeding. Bio-scaffolds are widely used in regenerative therapies for the treatment of bone, cartilage, skin, vascular tissues, and skeletal muscles. With growing geriatric population, the demand for such orthopaedic regenerative therapies is expected to increase significantly during the forecast period. This will have a positive impact on the demand for amniotic membranes.

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Major Five Amniotic Membrane Market Companies:

Celularity Inc.

Celularity Inc. operates its business through the Unified Business Segment. BIOVANCE is the key offering of the company. It offers a decellularized, dehydrated human amniotic membrane allograft that contains natural extracellular matrix (ECM) that helps in wound regeneration and tissue restoration.

Human Regenerative Technologies LLC

Human Regenerative Technologies LLC operates the business across segments such as Flowable and Membrane. HydraTek amniotic membrane products, is the key offering of the company. It includes thin and thick dehydrated amniotic membranes used in covering and protecting the recipient's tissue.

Integra LifeSciences Holdings Corp.

Integra LifeSciences Holdings Corp. operates its business across segments such as Codman Specialty Surgical, and Orthopedics and Tissue Technologies. The company offers a wide range of amniotic membrane products. Some of the key offerings include AmnioExcel Amniotic Allograft Membrane, BioDDryFlex Amniotic Tissue Membrane, BioDOptix Amniotic Extracellular Membrane, and Integra BioFix Amniotic Membrane Allograft.

Katena Products Inc.

Katena Products Inc. operates the business across segments such as Instruments, Biologics, Plugs, Lenses, Devices, and Blink Medical. Amniotic Membrane Surgical and Amniotic Membrane Clinic are some of the key offerings of the company.

MiMedx Group Inc.

MiMedx Group Inc. operates the business in the Regenerative biomaterial products and bioimplants segment. The company offers a wide range of amniotic membrane products. AmnioFix, EpiFix, and EpiBurn are the key offerings of the company.

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Global Extracorporeal Membrane Oxygenation Machines Market Global extracorporeal membrane oxygenation machines market by geography (Asia, Europe, North America, and ROW) and modality (veno-venous and arterio-venous; and veno-arterial).

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Global Amniotic Membrane Market 2020-2024 | Evolving Opportunities with Celularity Inc. and Human Regenerative Technologies LLC | Technavio - Business...

Skin Stem Cells Comments Off on Global Amniotic Membrane Market 2020-2024 | Evolving Opportunities with Celularity Inc. and Human Regenerative Technologies LLC | Technavio – Business… | January 7th, 2020

Every year, BioSpace analyzes the biotech industry, looking for the hot new biotech startups to watch. We then produce the NextGen Bio Class of, twenty companies ranked based on several categories, including Finance, Collaborations, Pipeline, and Innovation. The companies were typically launched no more than 18 months before the list was created.

We thought it would be insightful to look back at our previous lists to see where some of those companies are today. Heres a look at the top three companies from the Top 20 Life Science Startups to Watch in 2018.

#1. BlueRock Therapeutics. Founded in 2016, BlueRock was #1 on our list of companies to watch in 2018. With facilities in Ontario, Canada; Cambridge, Massachusetts; and New York, New York, BlueRock launched in December 2016 with a $225 million Series A financing led by Bayer AG and Versant Ventures. The company focuses on cell therapies to regenerate heart muscle in patients who have had a heart attack or chronic heart failure, as well as therapies for patients with Parkinsons disease.

In October 2017, BlueRock and Seattle-based Universal Cells entered into a collaboration and license deal to create induced pluripotent stem (iPS) cell lines that can be used in the manufacture of allogeneic cellular therapies. Shortly afterwards, the company established its corporate headquarters in Cambridge, and in April 2018, established a research-and-development hub in New York City, as well as formalizing a sponsored research collaboration with the Center for Stem Cell Biology at Memorial Sloan Kettering (MSK) Cancer Center. The collaboration focuses on translating Ketterings expertise in creating multiple types of authentic neural cells from stem cells to address diseases of the central and peripheral nervous system. BlueRock also received $1 million from the State of New York and Empire State Development under its economic development initiatives program.

In April 2019, BlueRock partnered with Editas Medicine (which was on BioSpaces NextGen Bio Class of 2015 list) to combine their genome editing and cell therapy technologies to focus on novel engineered cell medicines. Part of the deal was to collaborate on creating novel, allogeneic pluripotent cell lines using a combination of Editas CRISPR genome editing technology and BlueRocks iPSC platform.

And finally, in August 2019, Bayer AG acquired BlueRock for the remaining stake in the company for about $240 million in cash and an additional $360 million in pre-defined development milestones.

#2. Prelude Fertility. Prelude Fertility is a bit of an outlier from the typical BioSpace NextGen company, because it isnt quite a biopharma company. It is a life sciences company whose business model is aimed at in vitro fertilization and egg freezing. It was founded with a $200 million investment by entrepreneur Martin Varsavsky. The investment was in the largest in vitro fertilization clinic in the Southeast, Reproductive Biology Associates of Atlanta, and its affiliate, My Egg Bank, the largest frozen donor egg bank in the U.S.

Since then it has expanded in various parts of the country, including adding San Francisco-based Pacific Fertility Center (PFC) to its network in September 25, 2017; partnering with Houston Fertility Institute and acquiring Vivere Health; partnering with the Advanced Fertility Center of Chicago; and in October 2018, partnered with NYU Langone Health.

In March 2019, Prelude merged with Inception Fertility to establish the Prelude Network as the fastest-growing network of fertility clinics and largest provider of comprehensive fertility services in the U.S. Inception is acting as the parent company, with the Prelude Network, both having board representatives from the previous organizations.

#3. Relay Therapeutics. Ranking #3 on our list for 2018, Relay Therapeutics launched in September 2016 with a $57 million Series A financing led by Third Rock Ventures with participation form D.E. Shaw Research. On December 14, 2017, it closed on a Series B round worth $63 million, led by BVF Partners, with new investors GV (formerly Google Ventures), Casdin Capital, EcoR1 Capital and Section 32.

The company focuses on the relationship between protein motion and function. It merges computational power with structural biology, biophysics, chemistry and biology. In December 2018, the company completed a $400 million Series C financing. It was led by the SoftBank Vision fund and included additional new investors, Foresite Capital, Perceptive Advisors and Tavistock Group. Existing investors also participated.

The company announced at the time it planned to use the funds to accelerate the implementation of its long-term strategy, expanding its discovery efforts, advancing existing programs into the clinic and improving its platform.

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Where Are They Now? Top 3 Biotech Startups From NextGen Bio Class of 2018 - BioSpace

IPS Cell Therapy Comments Off on Where Are They Now? Top 3 Biotech Startups From NextGen Bio Class of 2018 – BioSpace | January 7th, 2020

In theglobalstem cells marketa sizeable proportion of companies are trying to garner investments from organizations based overseas. This is one of the strategies leveraged by them to grow their market share. Further, they are also forging partnerships with pharmaceutical organizations to up revenues.

In addition, companies in the global stem cells market are pouring money into expansion through multidisciplinary and multi-sector collaboration for large scale production of high quality pluripotent and differentiated cells. The market, at present, is characterized by a diverse product portfolio, which is expected to up competition, and eventually growth in the market.

Some of the key players operating in the global stem cells market are STEMCELL Technologies Inc., Astellas Pharma Inc., Cellular Engineering Technologies Inc., BioTime Inc., Takara Bio Inc., U.S. Stem Cell, Inc., BrainStorm Cell Therapeutics Inc., Cytori Therapeutics, Inc., Osiris Therapeutics, Inc., and Caladrius Biosciences, Inc.

Request PDF Sample of Stem Cells Market Report @https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=132

As per a report by Transparency Market Research, the global market for stem cells is expected to register a healthy CAGR of 13.8% during the period from 2017 to 2025 to become worth US$270.5 bn by 2025.

Depending upon the type of products, the global stem cell market can be divided into adult stem cells, human embryonic stem cells, induced pluripotent stem cells, etc. Of them, the segment of adult stem cells accounts for a leading share in the market. This is because of their ability to generate trillions of specialized cells which may lower the risks of rejection and repair tissue damage.

Depending upon geography, the key segments of the global stem cells market are North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. At present, North America dominates the market because of the substantial investments in the field, impressive economic growth, rising instances of target chronic diseases, and technological progress. As per the TMR report, the market in North America will likely retain its dominant share in the near future to become worth US$167.33 bn by 2025.

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Investments in Research Drives Market

Constant thrust on research to broaden the utility scope of associated products is at the forefront of driving growth in the global stem cells market. Such research projects have generated various possibilities of different clinical applications of these cells, to usher in new treatments for diseases.Since cellular therapies are considered the next major step in transforming healthcare, companies are expanding their cellular therapy portfolio to include a range of ailments such as Parkinsons disease, type 1 diabetes, spinal cord injury, Alzheimers disease, etc.

The growing prevalence of chronic diseases and increasing investments of pharmaceutical and biopharmaceutical companies in stem cell research are the key driving factors for the stem cells therapeutics market. The growing number of stem cell donors, improved stem cell banking facilities, and increasing research and development are other crucial factors serving to propel the market, explains the lead analyst of the report.

This post was originally published on Food and Beverage Herald

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Stem Cells Market Segmentation and Analysis Report, 2025 - Food & Beverage Herald

Spinal Cord Stem Cells Comments Off on Stem Cells Market Segmentation and Analysis Report, 2025 – Food & Beverage Herald | January 7th, 2020

Funding to Support Ongoing Advancement of siFi2, Lead Candidate from Companys First-of-its-Kind Platform for Precisely Controlling Core Cell Migration Mechanisms

NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- MicroCures, a biopharmaceutical company developing novel therapeutics that harness the bodys innate regenerative mechanisms to accelerate tissue repair, today announced that it has been awarded a Phase 2 Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The two-year, $1.5 million award will support ongoing development of the companys lead product candidate, siFi2. siFi2, a small interfering RNA (siRNA) therapeutic that can be applied topically, is designed to enhance recovery after trauma. This Phase 2 grant continues the companys successful Phase 1 SBIR contract which demonstrated significantly improved repair of burn wounds following treatment with siFi2 in animal models.

MicroCures technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the bodys innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins (MRPs).

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures technology directs and enhances the bodys inherent healing processes through local, temporary modulation of cell motility. The companys lead drug candidate, siFi2, is a topical siRNA-based treatment designed to silence the activity of Fidgetin-Like 2 (FL2), a fundamental MRP, within an area of wounded tissue. In doing so, the therapy temporarily triggers accelerated movement of cells essential for repair into an injury area. Importantly, based on its topical administration, siFi2 can be applied early in the treatment process as a supplement to current standard of care.

We are grateful for NIHs continued support of our work through this multi-year Phase 2 SBIR grant. This non-dilutive financial support allows us to continue building a robust portfolio of preclinical data in animal models that demonstrate the therapeutic potential of siFi2 to significantly improve and accelerate healing of burn wounds, said David Sharp, Ph.D., co-founder and chief science officer of MicroCures. This funding will help advance our research as we work towards first-in-human clinical trial in 2020.

The initial Phase 1 SBIR grant from NIH funded preclinical research by MicroCures which demonstrated that treatment with siFi2 accelerated re-epithelization, improved collagen deposit and maturation, and improved quality of healing in a porcine full thickness burn model. Specific findings showed that following eight weeks of treatment, 39% of siFi2-treated wounds were closed as compared to only 11% for control subjects and 0% for placebo. Additionally, siFi2-treated subjects demonstrated a significantly improved rate of healing as measured by epithelial surface measurements as compared to placebo (p = 0.0106) and control (p = 0.0012).

About MicroCures

MicroCures develops biopharmaceuticals that harness innate cellular mechanisms within the body to accelerate and improve recovery after traumatic injury. MicroCures has developed a first-of-its-kind therapeutic platform that precisely controls the rate and direction of cell migration, offering the potential to deliver powerful therapeutic benefits for a variety of large and underserved medical applications.

MicroCures has developed a broad pipeline of novel therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. The companys lead therapeutic candidate, siFi2, targets excisional wound healing, a multi-billion dollar market inadequately served by current treatments. Additional applications for the companys cell migration accelerator technology include dermal burn repair, corneal burn repair, cavernous nerve regeneration, spinal cord regeneration, and cardiac tissue repair. Cell migration decelerator applications include combatting cancer metastases and fibrosis. The company protects its unique platform and proprietary therapeutic programs with a robust intellectual property portfolio including eight issued or allowed patents, as well as eight pending patent applications.

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For more information please visit: http://www.microcures.com

Disclaimer: The SBIR Grant (2R44AR070696-02A1) is supported by the NIHs National Institute of Arthritis and Musculoskeletal and Skin Diseases. The content of this press release is solely the responsibility of MicroCures and does not necessarily represent the official views of the NIH.

Contact:

Vida Strategic Partners (On behalf of MicroCures)

Stephanie Diaz (investors)415-675-7401sdiaz@vidasp.com

Tim Brons (media)415-675-7402tbrons@vidasp.com

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MicroCures Awarded $1.5M SBIR Grant To Support Development of Novel Therapeutic Platform for Accelerated Tissue Repair - Yahoo Finance

Cardiac Stem Cells Comments Off on MicroCures Awarded $1.5M SBIR Grant To Support Development of Novel Therapeutic Platform for Accelerated Tissue Repair – Yahoo Finance | January 7th, 2020

NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Chaim Lebovits, President and Chief Executive Officer, will provide a corporate overview at the 2020 Biotech Showcase, being held on January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California.

Mr. Lebovits will also present at the 3rd Annual Neuroscience Innovation Forum, taking place on January 12, 2020, at the Marines Memorial Club in San Francisco. Additionally, Ralph Kern M.D., MHSc, BrainStorms Chief Operating Officer and Chief Medical Officer, will participate on aRare & Orphan Diseases Panel.

Meetings

BrainStorms senior management will also be hosting institutional investor and partnering meetings at the 2020 Biotech Showcase conference (https://goo.gl/SGFm62). Please use the Investor contact information provided below to schedule a meeting.

About NurOwn

NurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at http://www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Cell Therapeutics to Present at the 2020 Biotech Showcase and 3rd Annual Neuroscience Innovation Forum at JPM Week - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BrainStorm Cell Therapeutics to Present at the 2020 Biotech Showcase and 3rd Annual Neuroscience Innovation Forum at JPM Week – Yahoo Finance | January 7th, 2020

Cynata Therapeutics (CYP) has received a research and development tax incentive refund of $1,891,795 for the 2018-2019 financial year.

This tax incentive refund increases the company's cash position which stood at $9.2 million at the end of the September quarter.

It also enables further resources to be invested towards Cynata's phase 2 clinical trial programs for the critical limb ischemia (CLI) (reduced blood flow) and osteoarthritis products.

This will be alongside the anticipated phase 2 trial for CYP-001 in graft-versus-host disease which will be conducted by Fujifilm.

CLI is an advanced stage of peripheral artery disease which is the narrowing of the arteries in the limbs, typically in the lower legs.

It results from severely impaired blood flow which can cause pain, tissue damage, and gangrene.

Around 25 per cent of CLI patients who are unable to undergo surgery to remove the affected area, often an amputation, will die within a year of diagnosis.

Cynata' Cymerus mesenchymal stem cells (MSCs) have been successfully tested in a mouse model of CLI.

Muscles on the ischaemic leg were injected with Cymerus MSCs or a control.

Over a four-week follow-up period, the return of blood flow was measured and in animals treated with Cymerus MSCs blood flow in the injured limb was significantly higher at every point compared to the control.

MSCs are an adult stem cell found in a wide range of human tissues including bone marrow, fat tissue and placenta.

They are multi-potent which means they can produce more than one type of cell, for example they can differentiate into cartilage cells, bone cells and fat cells.

MSCs have been shown to ease regeneration and effects on the immune system without relying on engraftment (when the transplanted cells start to grow and make healthy cells).

The research and development tax incentive is an important Australian Government program that encourages companies to engage in research and development benefiting Australia by providing a tax offset for eligible activities.

Cynata's share price is up a steady 4.82 per cent with shares trading for $1.20 apiece at 3:29 pm AEDT.

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Cynata Therapeutics (ASX:CYP) receives R&D tax incentive refund of more than $1.8M - The Market Herald

Bone Marrow Stem Cells Comments Off on Cynata Therapeutics (ASX:CYP) receives R&D tax incentive refund of more than $1.8M – The Market Herald | January 7th, 2020

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-604 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC). In the study, treatment with KEYTRUDA in combination with chemotherapy (etoposide plus cisplatin or carboplatin) resulted in a statistically significant improvement in PFS compared to chemotherapy alone (HR=0.75 [95% CI, 0.61-0.91]), which was observed at a prior interim analysis. At the final analysis of the study, there was also an improvement in overall survival (OS) for patients treated with KEYTRUDA in combination with chemotherapy compared to chemotherapy alone; however, these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.80 [95% CI, 0.64-0.98]). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.

Results of KEYNOTE-604 demonstrated the potential of KEYTRUDA, in combination with chemotherapy, to improve outcomes for patients newly diagnosed with extensive stage small cell lung cancer, a highly aggressive malignancy, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. We sincerely thank the patients and investigators for their participation in this study and are committed to helping patients who face difficult-to-treat types of lung cancer.

In addition to KEYTRUDAs five current indications in lung cancer, Merck is continuing to study KEYTRUDA across multiple settings and stages of lung cancer through a broad clinical program, which is comprised of more than 10,000 patients enrolled or expected to be enrolled across 20 Merck-sponsored clinical studies.

About KEYNOTE-604

KEYNOTE-604 is a randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT03066778) investigating KEYTRUDA in combination with chemotherapy compared to chemotherapy alone in patients with newly diagnosed ES-SCLC. The dual primary endpoints were OS and PFS. Secondary endpoints included objective response rate (ORR), duration of response (DOR), safety and quality of life (QoL). The study enrolled 453 patients who were randomized to receive either:

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers. The five-year survival rate for patients diagnosed in the U.S. with any stage of SCLC is estimated to be 6%.

About KEYTRUDA (pembrolizumab) Injection, 100mg

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 1,000 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 patients 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 one 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.

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.

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).

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 hypophysitis, thyroid disorders, and type 1 diabetes mellitus. 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 hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 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; 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%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 34) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

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Merck's KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as...

Skin Stem Cells Comments Off on Merck’s KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as… | January 7th, 2020

In high school Aaron Sandoval became obsessed with Deadpool, Marvels comic character who has accelerated healing and regenerative powers.

Sandoval has turned in his superhero cape for a lab coat in medicine by working with reparative methods for the human body. And now, hes received a national award that will allow him to do that.

Sandoval, a 21-year-old UF biology senior, was selected for the Marshall Scholarship, which gives students in the U.S. a chance to pursue their graduate studies in the United Kingdom, all expenses paid. He is the second Marshall scholar in UFs history, following Steven Robinette in 2009.

Sandoval was one of 46 students chosen out of over 1,000 applicants across the U.S.

The Marshall Scholarship Program was created in 1953 to thank the U.S. for helping the U.K. after World War II under the Marshall Plan, which was the U.S.s way of helping European economies after the devastation of the war, according to the programs website.

It still hasnt really sunk in yet, Sandoval said. Im happy to have won it.

Sandoval said in his two years at the University of Cambridge and Kings College London hell study biochemistry and focus on the transfer of stem cells from the lab to the patients so they can understand what cells are being used to help them.

Sandoval has collaborated with UF faculty members like Malcolm Maden, a professor in UFs Cancer and Genetics Research Institute. Sandoval and Maden worked in a lab with an African spiny mouse, to figure out how stem cells repair parts of the human body like skin tissue.

In 2012, Maden and his research team discovered the African spiny mouses ability to regenerate skin scar free. Maden wrote one of Sandovals letters of recommendation for his application for the scholarship.

Sandoval said if the mouses regeneration of skin cells could be translated to humans, then a humans wounds could completely heal rather than scar.

Sandoval didnt have the opportunity to do research in high school and wanted to learn more at the university level, so he decided to take Madens lab.

Maden said Sandovals uniqueness stems from his intelligence, drive and ability to interact with different kinds of people.

Hes behaved like a dynamic scientist, not like an undergrad, he said. Completely amazing, totally unique guy.

Sandoval said he feels fortunate to have won the award and to have so many people who helped him get to this point.

I couldnt have done it without the support of family, friends, mentors, he said. It took a whole village to win this thing.

Contact Emma McAvoy at[emailprotected]. Follow her on Twitter@EmmaMcAvoy1.

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UF student chosen for the Marshall Scholarship, will pursue Masters degrees in United Kingdom - The Independent Florida Alligator

Skin Stem Cells Comments Off on UF student chosen for the Marshall Scholarship, will pursue Masters degrees in United Kingdom – The Independent Florida Alligator | January 6th, 2020

The latest lifestyle, fashion and travel trends

A high-end bio-beauty boom is in full bloom thanks to a host of revolutionary brands set on changing the face of modern skincare. These are the five to know...

Hailing from the Napa Valley, where founder April Gargiulo spent two years researching and developing her Holy Grail skincare products using the same meticulous approach her family took to their fine wine business, Vintners Daughter champions just two products that promise dramatic, multi-correctional results using some of the worlds most active organic and foraged botanicals. The original Active Botanical Serum (175) is hailed as the face oils to end all face oils and is built around the brands signature Phyto Radiance Infusion. This process starts with consciously grown whole plants such as calendula and super green alfalfa, known in ancient times as the foods of life, which undergo a methodical three-week long extraction to glean every last drop of their nutritional benefits. Just five drops using the brands 30-second Push/Press Method of application promises to deliver visible radiance, brightness and unparalleled nourishment particularly when used in conjunction with its preparatory Active Treatment Essence (210) (goop.com).

The undisputed Queen of Green, Tata Harper is a pioneer of the farm-to-face beauty movement with all-natural formulations handcrafted in the brands laboratory in Vermont and bottles stamped with a code to trace how fresh your product is and who it was made by. The beauty editors favourite is going one step further with the launch of its Supernaturals 2.0 line of six products boasting 155 ultramodern green ingredients from 46 countries and of course, no synthetic chemicals. The Elixir Vitae Serum (391) alone boasts 34 new radical engineered ingredients from 25 countries, including kelp polymers from France developed to target cellular ageing. Other highlights from the range include the Concentrated Brightening Serum (257), which contains 24 ingredients to hydrate, 17 to reduce wrinkles, 15 to brighten and 13 to even skin tone, and the Boosted Contouring Serum (257), designed to lift, firm and restore youthful elasticity with a combination of Edelweiss stem cells and skin revitalising pomegranate. (tataharperskincare.com)

The brainchild of cosmetologist Anna Buonocore and naturalist Jeanette Thottrup, Seed To Skin believes that effective skincare is threefold. Firstly, that wild ingredients foraged from the land and sea used in conjunction with those sourced from its organic Tuscan farm are among the most potent nature has to offer. Secondly, that just like feeding your body skin requires a healthy, balanced diet and formulas that neither starve nor overload with any one element. Finally, that the most effective absorption relies on a precise mix of perfectly-sized molecules to ensure each ingredient is delivered exactly where it needs to go. As a result, its award-winning product line is loaded with game changers try The AlcheMist Super Active Serum Spray (145) to feed your skin a nutrient-rich drink whenever it needs a boost, or the Black Magic Detoxifying Oxygen Therapy Mask (119) which contains activated charcoal and volcanic clay for a one-stop facial in a jar (libertylondon.com).

(Wildsmith )

Inspired by the arboretums progressive approach to cultivation at Hampshires Heckfield Place and named after its mastermind William Walker Wildsmith, this ethical crafted-in-England skincare brand is designed for those who desire natural products but demand clinical results. Exclusive to Harrods beauty halls, the hero additions to its product line-up include the Platinum Booster (175) a powerful skin-firming treatment powered by encapsulated oxygen and moss cell cultures and a reviving, collagen-boosting Copper Peptide Cream and Serum Duo (150) which delivers a luminous finish to your complexion and comes in a compostable mycelium box (wildsmithskin.com; harrods.com).

After turning to flower arranging as a weekly dose of mindfulness, beauty entrepreneur Kelly S Chung endeavoured to harness the healing power of nature or Flower Therapy, as she has coined it in another form; and Femmue was born. Fusing K-beauty innovation with a clean beauty ethos and the cellular energy of plants, the camellia flower is at the heart of the range and renowned for its antioxidant and restorative qualities. The Divine Camlia Facial Oil (100) is the purest form with 99.8 per cent camellia seed oil, while other must-try products in the line include the bestselling Flower Infused Fine Mask (40) formulated with camellia petals, geranium oil and cactus extract and the lavender-loaded Brilliant Cleansing Oil (73) (net-a-porter.com).

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Super Naturals: the high-tech natural beauty brands changing the face of modern skincare - Evening Standard

Skin Stem Cells Comments Off on Super Naturals: the high-tech natural beauty brands changing the face of modern skincare – Evening Standard | January 6th, 2020

Technavio has been monitoring the global amniotic membrane market since 2019 and the market is poised to grow by USD 1.48 billion during 2020-2024, progressing at a CAGR of more than 13% during the forecast period. Request a free sample report

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200106005080/en/

Technavio has announced its latest market research report titled global amniotic membrane market 2020-2024 (Graphic: Business Wire)

Read the 145-page report with TOC on "Amniotic Membrane Market Analysis Report by Geography (Asia, Europe, North America, and ROW), Type (Cryopreserved amniotic membrane and Dehydrated amniotic membrane), and the Segment Forecasts, 2020-2024".

https://www.technavio.com/report/amniotic-membrane-market-industry-analysis

The market is driven by the rising demand for biocompatible scaffolds. In addition, the rise in the development of new applications through research is anticipated to boost the growth of the amniotic membrane market.

The rising need for naturally derived materials in tissue scaffolding is increasing the demand for amniotic membranes. This is due to the specialized structure of amniotic membranes that exhibit high biological viability, making them ideal for creating bio-scaffolds. Moreover, the epithelial cells in amniotic membranes have the advantages of stem cells which provide a native environment of cell seeding. Bio-scaffolds are widely used in regenerative therapies for the treatment of bone, cartilage, skin, vascular tissues, and skeletal muscles. With growing geriatric population, the demand for such orthopaedic regenerative therapies is expected to increase significantly during the forecast period. This will have a positive impact on the demand for amniotic membranes.

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Major Five Amniotic Membrane Market Companies:

Celularity Inc.

Celularity Inc. operates its business through the Unified Business Segment. BIOVANCE is the key offering of the company. It offers a decellularized, dehydrated human amniotic membrane allograft that contains natural extracellular matrix (ECM) that helps in wound regeneration and tissue restoration.

Human Regenerative Technologies LLC

Human Regenerative Technologies LLC operates the business across segments such as Flowable and Membrane. HydraTek amniotic membrane products, is the key offering of the company. It includes thin and thick dehydrated amniotic membranes used in covering and protecting the recipient's tissue.

Integra LifeSciences Holdings Corp.

Integra LifeSciences Holdings Corp. operates its business across segments such as Codman Specialty Surgical, and Orthopedics and Tissue Technologies. The company offers a wide range of amniotic membrane products. Some of the key offerings include AmnioExcel Amniotic Allograft Membrane, BioDDryFlex Amniotic Tissue Membrane, BioDOptix Amniotic Extracellular Membrane, and Integra BioFix Amniotic Membrane Allograft.

Katena Products Inc.

Katena Products Inc. operates the business across segments such as Instruments, Biologics, Plugs, Lenses, Devices, and Blink Medical. Amniotic Membrane Surgical and Amniotic Membrane Clinic are some of the key offerings of the company.

Story continues

MiMedx Group Inc.

MiMedx Group Inc. operates the business in the Regenerative biomaterial products and bioimplants segment. The company offers a wide range of amniotic membrane products. AmnioFix, EpiFix, and EpiBurn are the key offerings of the company.

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Amniotic Membrane Type Outlook (Revenue, USD Billion, 2020 - 2024)

Amniotic Membrane Regional Outlook (Revenue, USD Billion, 2020 - 2024)

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more. Request a free sample report

Related Reports on Healthcare include:

Global Extracorporeal Membrane Oxygenation Machines Market Global extracorporeal membrane oxygenation machines market by geography (Asia, Europe, North America, and ROW) and modality (veno-venous and arterio-venous; and veno-arterial).

Global Duchenne Muscular Dystrophy (DMD) Therapeutics Market Global Duchenne muscular dystrophy (DMD) therapeutics market by type (biologics and small molecules) and geography (Asia, Europe, North America, and ROW).

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Global Amniotic Membrane Market 2020-2024 | Evolving Opportunities with Celularity Inc. and Human Regenerative Technologies LLC | Technavio - Yahoo...

Skin Stem Cells Comments Off on Global Amniotic Membrane Market 2020-2024 | Evolving Opportunities with Celularity Inc. and Human Regenerative Technologies LLC | Technavio – Yahoo… | January 6th, 2020

Being jam-packed with various essential nutrients like folate, Vitamin A, beta carotene, etc., carrot and ginger can offer you both health and beauty benefits. These kitchen companions can help diabetics to control their blood sugar level and have many more medicinal uses. These vegetables are known to treat ailments like cough and cold, nausea, anxiety, etc. From strengthening your immune system to protecting your against cancer and boosting collagen production, carrot ginger juice can do it all for you. Below, we give you more than one reason to add this juice to your daily diet.

Being a rich source of vitamin A, carrot ginger juice helps in strengthening your immune response. This nutrient is required to form white blood cells in the bone marrow stem cells. Notably, WBC is a significant component of your bodys defence system. So, it is advised to drink this juice on a daily basis. You can add oranges in the juice to make it a bit tasty.

For a healthy skin texture and tone, vitamin C and E are needed. Carrot ginger juice is a rich source of both nutrients. Your skin requires collagen for better elasticity, texture, and strength. Vitamin C helps in the synthesis of this protein and holds the body together. Even if you have a skin wound, you can have this drink and get rid of the problem soon. On the other hand, vitamin E protects your skin from the harmful effects of UV rays.

Carrot ginger juice is a detox drink that is jam-packed with vitamin C, a nutrient that is already linked to providing protection against cancer. The juice contains a compound called gingerol, that can potentially reduce your risk of developing breast, ovarian, and stomach cancers. This is what research published in the European Journal of Pharmacology reveals.

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Want to Rev up Your Immunity And Improve Skin Health? Consume Carrot Ginger Juice - India.com

Skin Stem Cells Comments Off on Want to Rev up Your Immunity And Improve Skin Health? Consume Carrot Ginger Juice – India.com | January 5th, 2020

3 January 2020

Victoria Beckham aims to "create a brand of the future" with Victoria Beckham Beauty.

Victoria Beckham

The former Spice Girl launched her eponymous beauty brand last year, later expanding her label to include skincare, and the 45-year-old fashion designer says her intention was to create products that are sustainable and not made from toxic formulas, whilst being "inclusive" for all skin tones.

The mother-of-four told the February issue of Harper's Bazaar UK: "I've been obsessed with make-up and skincare and wellness for longer than I can remember.

"But I couldn't find what I wanted - clean beauty.

"What is that, even? It's a real grey area.

"I wanted to create a brand of the future - focusing on what's in the formulas but then also sustainability.

"The other thing that was key was making sure it was very inclusive - whether it's make-up or skincare, this is for every skin type and tone, and for both women and men."

In November, Victoria - who has Brooklyn, 20, Romeo, 17, Cruz, 14 and Harper, eight, with retired soccer star husband David Beckham - released her Cell Rejuvenating Priming Moisturiser in collaboration with Professor Augustinus Bader, the German stem-cell scientist behind The Cream, which was named as one of 2019's most popular skincare products.

Bader's product features a patented Trigger Factor Complex that works to jumpstart your skin's repair and renewal functions to heal skin faster and in turn, improve the appearance of fine lines and wrinkles, and as a fan of the cream herself, Victoria was thrilled to work with the scientist.

She said: "It's been a dream to develop, with Augustinus, a priming moisturiser that works to improve the health of my skin and gives me that fresh, natural glow that I love."

The priming moisturiser is a hybrid product that combines primer with moisturiser, and is inspired by Victoria's own skincare routine.

Victoria's product implements Bader's Trigger Factor Complex technology, as well as the lipids, vitamins, and amino acids found in his original cream, but with the added benefit of also smoothing skin so it's prepped for make-up application.

Bader explained: "It's the first priming moisturiser of its kind to care for your skin cells while also preparing your skin for makeup application."

The cream has a lightweight texture that can be work alone to give skin a radiant finish or under make-up, which according to Victoria, "will enhance your products."

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Victoria Beckham wants her beauty line to be 'brand of the future' - FemaleFirst.co.uk

Skin Stem Cells Comments Off on Victoria Beckham wants her beauty line to be ‘brand of the future’ – FemaleFirst.co.uk | January 5th, 2020

Its not easy to choose the right skin creams! There are so many new products on the market, beckoning us to buy them. With fancy campaigns and big budgets, who knows which ones are the best?

While we like to think we actually getbetterwith age, we totally understand that there might be some pesky skin changes you want to address as the years pass. Its difficult to pinpoint exactlywhen to startincorporating anti-aging products into your routine, so we chatted with one of our favorite celebrity experts, Nicole Baca, who createdOverdoseto get the scoop on the best approach to wrinkle creams.

Not only is Baca an award-winning leading independent skincare specialist in the U.S, who produced the top-selling product Overdose,but she is also a well-known advisor and specialist in elite Hollywood circles, and in todays current market, that means everything!

While different age groups require different routines, the best anti-aging product issunblock, which Baca recommends be applied to the face daily as young as possible! In individuals with dry skin,a daily moisturizer,serum, andeye creamshould be started in the early 20s, says Baca.

If the individual has oily skin, traditional anti-aging products can start in their 30s, but most likely they will be using aretinol product to combat acne breakouts, so they are already using preventative measures.

When comparing products, opt for ones with retinol,hyaluronic acid,plant-based stem cells,resveratrol, andglycolic acid. Exfoliation is essential! Baca says.

Armed with that info, we set out to research and find the right anti-aging creams that fight wrinkles. Our list (of course) includes J.Nicoles Overdose.

Ready to find the best wrinkle cream for you? Read on to learn more about our top picks.

Body Merry Retinol Surge Moisturizer $22.98 SHOP NOW

Wildly Popular Aretinol creamcanmakeyourskin appear more youthfulover time, and this is our favorite one at a budget-friendly price. Wed expect to pay more for resultsthislegit, but this steal fromBody Merry truly works to improve aging skin.

TheRetinol Surge Moisturizer addresses wrinkles and uneven skin tone, providing the kind of results youd expect from a professional product.

ELEMIS Pro-Collagen Marine Cream $120.47-$96.00 (20% off) SHOP NOW

Feels Amazing This silky, moisturizing cream not only feels amazing on your skin, but it contains a mix of powerful ingredients like Mediterranean algae, gingko biloba, chlorella, mimosa, and rose that work to visibly reduce fine lines and wrinkles in just 14 days. Fewer linesandplump skin? Yes, please!

OVERDOSE Bio-Hybrid Technology $95.00 SHOP NOW

Skin Care Essentials J.Nicole uses patent-pending formula to combine seven separate skin care products into one easy to use formula. Their unique serum utilizes the high oleic acid found within specially-bred hybrid sunflowers, delivering a super-saturated boost of skin care essentials deep into your skin without any irritation. Simply apply once a day after cleansing for instantly clearer, brighter, and youthful skin.

Rodial Dragons Blood Hyaluronic Night Cream $72.00-$58.50 (19% off) SHOP NOW

Potent Ingredients Rodials Dragons Blood Hyaluronic Night Cream offers potent ingredients in a light, buttery cream that smells divine. This anti-aging cream contains time-released retinol, penetrating deep into the skin as you sleep to help reduce lines and wrinkles. It also contains hyaluronic acid to pump long-lasting hydration into the deepest layers of the skin.

Olay Regenerist Micro-Sculpting Cream $20.03 SHOP NOW

Fast-Acting Formula Give this anti-wrinkle cream by Olay a spin for line-free skin. The fast-action formula starts reducing wrinkles instantly with a blend of hyaluronic acid, vitamin B, and amino-peptides, so if youre in a rush to reduce age marks on a budget, Olay has found the way.

RoC Retinol Correxion Deep Wrinkle Anti-Aging Retinol Night Cream $16.79 SHOP NOW

Works While You Sleep Theres hardly a list of wrinkle creams without mention of RoCs Retinol Correxion products. Our favorite drugstore buy, this night cream uses a retinol-packed formula to improve skin while you sleep! Youll see a reduction incrows feet, under-eye wrinkles, and deep lines with 12 weeks of use.

Derma-E Anti-Wrinkle Renewal Skin Cream $11.96SHOP NOW

Vegan and Cruelty-Free Experience anti-aging benefits around the clock with this cream from Derma-E that can be used day or night. A rich mix of vitamin A (aka retinol), vitamin E, allantoin, panthenol, and nourishing oils works together to soften skin and reduce the look of wrinkles.

Neutrogena Anti-Wrinkle Deep Wrinkle Daily Moisturizer$21.99-$13.47 (39% off) SHOP NOW

Contains Sunscreen When using a retinol, you shouldalwaysbe usingan SPF, too. (Which, TBH, you should be wearing anyway.) This daily moisturizer from Neutrogena containsboth!

Its also formulated withhyaluronic acid,which plumps up skinand helps it retain moisture.

The Inkey List Bakuchiol Moisturizer $9.99 SHOP NOW

Retinol Alternative If you havent yet heard of Bakuchiol, youll want to try this buzzy skincareingredient ASAP! Itsthe gentler, plant-derived alternative to retinol, and provides similar anti-aging effects without any of the irritation or sensitivity to the sun.

Plus, unlike regular retinol,its a safe pick for pregnant or breastfeeding moms, too.You cant beat the value ofThe Inkey Lists under-$10version.

Skinmedica Dermal Repair Cream $103.20 SHOP NOW

Skincare Staple A staple from one of Vielbigs recommended brands, this all-encompassing hydrating treatment deserves a spot in your skincare regimen ASAP. Formulated with hyaluronic acid, vitamin C, and other wrinkle-fighting ingredients, this cream effectively penetrates the skin to turn back the clock and provide you witha more youthful appearance.

SkinCeuticals A.G.E. Interrupter Mature Skin Treatment $157.75 SHOP NOW

A Best-Seller This best-selling anti-aging cream from SkinCeuticals slows the loss of elasticity in your skin and keeps your collagen levels up. Formulated with 30% concentration of Pro-Xylane, 4% blueberry extract, and 0.2% phytosphingosine, this anti-wrinkle treatment helps restore the loss of visible skin firmness.

Obagi Hydrate Luxe $74.00 SHOP NOW

Expert-Approved A favorite brand recommended byour skincare expert, this moisture-rich cream from Dr. Obagi is life-changing. It features nourishing shea butter, along with peptides designed to capture moisture andsupport cell-repair processes.

Dr. Dennis Gross C+ Collagen Deep Cream $72.00 SHOP NOW

Deeply-Penetrating When it comes to youthful-looking skin, collagen is one of your besties. Implement Dr. Dennis Grosss deeply penetrating cream into your skin care routine to postpone age spots and wrinkles.

The potent, vitamin C-infused formula also features sunflower, rice bran, and camellia japonica seed oils that work to increase moisture retention.

DHC CoQ10 Quick Gel Brightening Moisture $61.26 SHOP NOW

Absorbs Quickly How did we live without this anti-aging wonder cream from DHC? Bursting with age-defying coenzyme Q10, this antioxidant-rich gel cream absorbs quickly to deliver potent ingredients in a flash. It promotes elasticity while vitamin C and daisy extract help brighten for a more luminous complexion.

This cream tones, brightens, and moisturizes in one step, making itperfect to wear with or without makeup.

IMAGE Skincare Ageless Total Overnight Retinol Masque $72.00$-60.39 (16% off) SHOP NOW

Retinol-Infused Goodness We love using this retinol-infused goodness from IMAGE Skincare as a night cream around threetimes per week. Simply slather it on before bed, and itll continuously release marine collagen microspheres and retinol into the skin to lock in moisture while you sleep. Youll wake up looking fresh and young!

Dr. Barbara Sturm Anti-Aging Body Cream $95.00 SHOP NOW

For Your Whole Body While we know your facial anti-aging cream is top of mind, dont forget about the rest of your skin! We live for Dr. Barbara Sturms Anti-Aging Body Cream. Its on the pricier side, but the serious results make it worth the splurge.

It contains a slew of nourishing ingredients, including olive oil, lactic acid, vitamin C, and vitamin B-5, to improve the appearance of fine lines and wrinkles on your body.

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We asked beauty expert Nicole Baca for advice on the best skincare treatments on the market - Globe Stats

Skin Stem Cells Comments Off on We asked beauty expert Nicole Baca for advice on the best skincare treatments on the market – Globe Stats | January 5th, 2020