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AMC to use stem cell therapy in treating graft-versus-host disease – Korea Biomedical Review

By daniellenierenberg

Korean researchers have found a signal transduction system that modulates the treatment of mesenchymal stem cells and immune control functions, opening the way for treating graft-versus-host disease treatment.

Mesenchymal stem cells divide into various cells, have immunomodulatory functions, and are the primary cell sources for stem cell therapy.

Graft-versus-host disease is a fatal disease that leads to death after an allogeneic blood transfusion or bone marrow transplantation. Although there are many clinical trials underway worldwide to treat the symptom, there are no applicable treatments besides alleviating symptoms with high-dose steroids.

The team, led by Professor Shin Dong-myeong of the Department of Biomedical Sciences at Asan Medical Center, discovered that the CREB1 (CAMP responsive element binding protein 1) signaling system activates the treatment and immune control functions of mesenchymal stem cells.

The team administered a therapeutic agent made by upgrading mesenchymal stem cells to graft-versus-host disease mice, and found that it alleviated anorexia symptoms and reduced the weight loss rate by 30 percent while increasing the survival rate by 30 percent.

When developing a cell therapy product, researchers have to cultivate the stem cells in vitro. Thus it is very likely that it will impair stem cell functions due to free radicals generated in the cells. To prevent the deterioration of stem cell function, it is necessary to improve the stem cell function in vitro culture, prevent stem cell oxidation, and increase the antioxidant capacity of the cell itself.

Until now, there was a lack of specific evidence and understanding of how stem cells regulate glutathione, an indicator of antioxidant capacity. Therefore, it was difficult to prevent stem cell dysfunction and oxidation.

Professor Shin's team developed experimental techniques that can monitor and quantify glutathione in real-time and confirmed that the CREB1 signaling system regulated the amount and activity of glutathione.

By activating the CREB1 signaling system, the team found that the process also activated nuclear factor erythroid 2-related factor 2 (NRF2) protein, which maintains the antioxidant capacity of mesenchymal stem cells and the increase of both the expression levels of peroxiredoxin-1 (PRDX1) and glutamate-cysteine ligase modifier subunit (GCLM) protein, which synthesize glutathione and are antioxidant activity indicators.

As a result, the team confirmed that its method was effective in treating the graft-versus-host disease.

"Based on this study, we have secured a technological foundation to advance stem cell treatment by controlling the antioxidant capacity of stem cells," Professor Shin said.

If this technology makes a high-purity and high-quality stem cell treatment, the team expects that it will be a step toward developing a graft-versus-host disease treatment and overcoming various intractable diseases such as nervous system diseases and inflammatory diseases with high medical demand, Shin added.

The results of the study were published in the journal, Science Advances.

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UB investigators uncover cellular mechanism involved in Krabbe disease – UB Now: News and views for UB faculty and staff – University at Buffalo…

By daniellenierenberg

A group of UB researchers have published a paper that clarifies certain cellular mechanisms that could lead to improved outcomes in patients with globoid cell leukodystrophy, commonly known as Krabbe disease.

The paper, titled Macrophages Expressing GALC Improve Peripheral Krabbe Disease by a Mechanism Independent of Cross-Correction, was published May 5 in the journal Neuron.

The research was led by Lawrence Wrabetz and M. Laura Feltri. Wrabetz and Feltri head the Hunter James Kelly Research Institute and both are professors in the departments of Biochemistry and Neurology in the Jacobs School of Medicine and Biomedical Sciences at UB.

The institute is named for the son of former Buffalo Bills quarterback Jim Kelly. Hunter Kelly died at age 8 in 2005 from complications of Krabbe disease.

Krabbe disease is a progressive and fatal neurologic disorder that usually affects newborns and causes death before a child reaches the age of 2 or 3.

Traditionally, hematopoietic stem cell transplantation, also known as a bone marrow transplant, has improved the long-term survival and quality of life of patients with Krabbe disease, but it is not a cure.

It has long been assumed that the bone marrow transplant works by a process calledcross-correction, in which an enzyme called GALC is transferred from healthy cells to sick cells.

Using a new Krabbe disease animal model and patient samples, the UB researchers determinedthatin reality cross-correctiondoes not occur. Rather, the bone marrow transplant helps patients through a different mechanism.

The researchers first determined which cells are involved in Krabbe disease and by which mechanism. They discovered that both myelin-forming cells, or Schwann cells, and macrophages require the GALC enzyme, which is missing in Krabbe patients due to genetic mutation.

Schwann cells require GALC to prevent the formation of a toxic lipid called psychosine, which causes myelin destruction and damage to neurons. Macrophages require GALC to aid with the degradation of myelin debris produced by the disease.

The research showed that hematopoietic stem cell transplantation does not work bycross-correction, but by providing healthy macrophages with GALC.

According to Feltri, the data reveal that improvingcross-correctionwould be a way to makebone marrow transplants and other experimental therapies such as gene therapy more effective.

Bone marrow transplantation and other treatments for lysosomal storage disorders, such as enzyme replacement therapy, have historically had encouraging but limited therapeutic benefit, says study first author Nadav I. Weinstock, an MD-PhD student in the Jacobs School. Our work defined the precise cellular and mechanistic benefit of bone marrow transplantation in Krabbe disease, while also shedding light on previously unrecognized limitations of this approach.

Future studies, using genetically engineered bone marrow transplantation or other novelapproaches,may one day build on our findings and eventually bridge the gap for effectively treating patients with lysosomal disease, he continues.

UB investigators included Daesung Shin, research assistant professor at the Hunter James Kelly Research Institute; Nicholas Silvestri, clinical associate professor of neurology, Jacobs School; Narayan Dhimal, PhD student; Chelsey B. Reed, MD-PhD student; and undergraduate student Oliver Sampson.

Also participating in the research were Eric E. Irons, MD-PhD student, and Joseph T.Y. Lau, a distinguished faculty member from the Department of Molecular and Cellular Biology at Roswell Park Comprehensive Cancer Center.

The research was funded by multiple grants from the National Institutes of Health awarded to Weinstock, Shin, Wrabetz and Feltri, and also supported by Hunters Hope.

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Broad Foundation brings together stem cell scientists, engineers and physicians at University of Southern – Mirage News

By daniellenierenberg

Developing new stem cell therapies requires more than a solo biologist having a eureka moment alone in the lab. Real progress relies on collaborations between biologists, engineers and physicians. Thats why The Eli and Edythe Broad Foundation has continued its support of two strategic initiatives: innovation awards bringing together teams of engineers and scientists from USC and Caltech, and clinical research fellowships for physician-scientists.

Engineering new approaches: The Broad Innovation Awards

For the fifth consecutive year, the Broad Innovation Awards are providing critical funding to USC-affiliated faculty members pursuing multi-investigator research collaborations related to stem cells. For the first year, these collaborations are also drawing on the expertise of biomedical engineers from Caltech. Each award provides $200,000 of funding for a one-year project.

Were very excited to be joining our colleagues at USC in pioneering new approaches to advancing stem cell research, said Stephen L. Mayo, chair of the Division of Biology and Biological Engineering at Caltech. Were thankful to The Broad Foundation for supporting cross-town collaborations between scientists with different expertise but common goals.

With support from a Broad Innovation Award, Andy McMahon, the director of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC, is collaborating with Caltech biomedical engineer Long Cai to leverage a new technology for understanding chronic kidney disease. The technology, called seqFISH, provides information about genetic activity taking place in intact tissueenabling the study of the interactions between cells in their native environments.

Dr. Cais seqFISH technology will provide an unprecedented insight into the cellular interplay underlying chronic kidney disease caused by a maladaptive response to acute kidney injury, said McMahon, who is the W.M. Keck Provost and University Professor of Stem Cell Biology and Regenerative Medicine, and Biological Sciences, as well as the chair of the Department of Stem Cell Biology and Regenerative Medicine at USC. We aim to better understand this maladaptive responsewhich is more common in malesin order to find new targets for preventing the progression to chronic kidney disease.

A second Broad Innovation Award brings together USC Stem Cell scientist Rong Lu and Caltech synthetic biologist Michael Elowitz. Their team will study the spatial organization of blood-forming stem and progenitor cells, also called hematopoietic stem and progenitor cells (HSPCs), which reside in the bone marrow. By pinpointing the locations of specific HSPCs, the scientists may find clues to explain why certain HSPCs are so dominantreplenishing the majority of the bodys blood and immune cells after a disruption such as a bone marrow transplantation.

Spatial advantages may be the primary drivers of what we refer to as the clonal dominance of certain HSPCs, said Lu, a Richard N. Merkin Assistant Professor of Stem Cell Biology and Regenerative Medicine, Biomedical Engineering, Medicine, and Gerontology at USC. Understanding the spatial competition between HSPCs could help improve bone marrow transplantation and provide new insights into aging and the development of diseases such as leukemiawhich are associated with clonal dominance.

Elowitz added: Thanks to the Broad Innovation Award and this exciting collaboration with Rong Lu, we will be able to bring a new, synthetic biology approach to record cell histories and read them out in individual cells within their native spatial context, providing new insights into fundamental questions in blood stem cell development.

A third Broad Innovation Award brings together three collaborators at USC: Michael Bonaguidi, an assistant professor of stem cell biology and regenerative medicine, biomedical engineering, and gerontology; Robert Chow, a professor of physiology and neuroscience, and biomedical engineering; and Jonathan Russin, an assistant professor of neurological surgery and associate surgical director for the USC Neurorestoration Center. Their project focuses on finding new approaches to treating epilepsy by studying neural cells called astroglia. These cells perform a variety of key functions that support the health of neurons in the brain, and they may also play a role in modulating epileptic seizures.

Although adults dont tend to generate many new brain cells, humans do produce a limited number of new astroglia, said Bonaguidi. We will examine these newborn astroglia at the single-cell level to better understand their role in epileptic patients, and to lay the groundwork for identifying new treatments.

The doctors are in: The Broad Clinical Research Fellowships

The Broad Clinical Research Fellowships are also entering their fifth consecutive year. These fellowships support stem cell research by physician-scientists and residents who intend to practice medicine in California.

These fellowships provide a very special opportunity for our medical residents to engage deeply in laboratory research, as a complement to their extensive training in patient care, said Laura Mosqueda, Dean of the Keck School of Medicine of USC. This valuable research experience gives them a much more complete perspective on how to meet the challenges of finding the best possible treatments for their patients.

A USC resident physician in general surgery, Kemp Anderson will spend his fellowship studying necrotizing enterocolitis, a very serious intestinal infection that affects nearly 10 percent of premature infants. Specifically, he will explore how a molecule involved in cellular communication, called farnesoid X receptor, or FXR, might contribute to this disease.

If FXR plays a role in compromising intestinal barrier function in these premature infants, then altering the activity of FXR could potentially yield treatment modalities for necrotizing enterocolitis, avoiding the morbidity and mortality associated with surgical intervention, said Anderson, who is performing the research under the mentorship of Christopher Gayer and Mark Frey at Childrens Hospital Los Angeles (CHLA). Im deeply appreciative of the benefactors and the selection committee for awarding me the Broad Clinical Fellowship, as it is allowing me devoted time to focus on this important project, and to become a more well-rounded physician through this academic pursuit.

Brittany Rocque, a resident physician in general surgery, will use her fellowship to seek better ways to predict, detect and diagnose immune rejection in patients who have undergone liver transplantation. Nearly 60 percent of pediatric patients and at least 15 percent of adult patients reject their liver transplants, and this can currently only be confirmed through an invasive surgical biopsy. Rocque is utilizing the technology Imaging Mass Cytometry to identify and analyze the types of immune cells involved in rejection.

My project has the potential to provide a noninvasive option to assess rejection in transplanted patients, and to expand our understanding of immune rejection, said Rocque, who is being co-mentored by Juliet Emamaullee and Shahab Asgharzadeh at CHLA. Im greatly looking forward to applying my passion for transplantation surgery in the context of basic science, and enhancing my appreciation for the nuances of research, thanks to the Broad Clinical Research Fellowship.

A hematology-oncology fellow who will be transitioning to a junior faculty position at USC next year, Caitlin ONeill will study a condition known as clonal hematopoiesis or CH, a phenomenon common in the aging population. CH involves genetic mutations that cause the expansion of a particular population of blood cells without leukemia or related malignancies. CH increases risks for certain health conditions including heart disease.

During her Broad Clinical Research Fellowship, ONeill will look at one mutation seen in patients with CH: a mutation to the gene called Tet methylcytosine dioxygenase 2, or TET2. ONeill will explore if this mutation promotes blood clots, inflammation and heart disease.

The goal is to inform therapies to prevent heart disease and leukemic progression in aging patients with CH, said ONeill, who is working with co-mentors Casey OConnell and Rong Lu at USC. Im very happy to be working on this project, with support from the Broad Clinical Research Fellowship, during my transition to becoming a faculty member at USC.

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Avrobio taps Magenta’s ADC in ongoing quest to improve gene therapy conditioning – FierceBiotech

By daniellenierenberg

Avrobio is working to make conditioning, a necessary step for some gene therapies, safer. But its not stopping at improving current approachesthe company is teaming up with Magenta Therapeutics to see whether an antibody-drug conjugate (ADC) can do the job.

Under the deal, the duo will test Magentas lead conditioning program, MGTA-117, alongside at least one of Avrobios gene therapies. Each company will hold onto the rights for their respective programs, but Avrobio will pick up the tab for clinical trials involving MGTA-117.

We believe targeted ADCs represent the next generation of medicines to prepare patients for gene therapy or transplant in a targeted, precise way This partnership will allow Magenta to validate our conditioning platform in lentiviral gene therapy applications, said Magenta CEO Jason Gardner, D.Phil., in a statement.

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Avrobios lead program is a gene therapy for Fabry disease dubbed AVR-RD-01. It is based on CD34+ stem cells that have been modified using a lentiviral vector to carry and express the gene that codes for the enzyme that is missing in Fabry disease. It is also working on treatments for Gaucher disease, Cystinosis and Pompe disease.

RELATED: Avrobio posts encouraging update for Fabry gene therapy phase 1, 2 trials

Patients undergoing lentiviral gene therapies must first take the chemotherapy drug busulfan in a process called conditioning, which helps the gene-modified stem cells take root in their bone marrow. Avrobio uses therapeutic drug monitoring to tailor busulfan dosing to each patient, to improve the odds of success for its gene therapies while tamping down on side effects. Some patients may be more susceptible to infection and bleeding after conditioning, and they may suffer side effects like nausea, hair loss and mouth sores.

MGTA-117 is made up of an anti-CD117 antibody linked to amanitin, a cell-killing toxin. It is designed to target only hematopoietic, or blood-forming, stem cells and progenitor cells. Animal studies suggest it could clear space in bone marrow for gene-modified stem cells to take root, Magenta said in the statement. The company plans to wrap IND-enabling studies for the antibody-drug conjugate this year.

The deal comes on the heels of a busulfan-focused one for Avrobio. The company joined forces with Saladex Biomedical on Monday to develop a rapid blood test that monitors how quickly patients metabolize the drug. The hope is to get results in minutes, rather than the hours that current methods take, so dosing can be adjusted quickly.

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Impact of Covid-19 Outbreak on Global Stem Cell Therapy Market Future Opportunities and Forecast Analysis 2020-2026 – Press Release – Digital Journal

By daniellenierenberg

"global Stem Cell Therapy market"

A new market study, titled Covid-19 Impact on Global Stem Cell Therapy Market Size, Status and Forecast 2020-2026 has been featured on WiseGuyReports.

The global Stem Cell Therapy market research offers a comprehensive overall market analysis focused on the latest findings. The introduction portion includes a brief overview of the industry, along with the product and service descriptions. This also includes the main applications for all end-user industries. The report also presents market prospects along with the forecast, with the study covering the period 2020-2026. The report includes an in-depth analysis of the major factors that could decide the market's trajectory in the coming years.

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

In the last several years, global stem cell therapy market developed fast at a average growth rate of 46.81%.

Competition Analysis

In the competitive analysis section of the report, leading as well as prominent players of the global Stem Cell Therapy market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.

The following players are covered in this report:

Osiris Therapeutics

NuVasive

Chiesi Pharmaceuticals

JCR Pharmaceutical

Pharmicell

Medi-post

Anterogen

Molmed

Takeda (TiGenix)

This report also analyses the impact of Coronavirus COVID-19 on the Stem Cell Therapy industry.

Regional and Country-level Analysis

The report offers an exhaustive geographical analysis of the global Stem Cell Therapy market, covering important regions, viz, North America, Europe, China, Japan, Southeast Asia, India and Central & South America. It also covers key countries (regions), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, UAE, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by each application segment in terms of revenue for the period 2015-2026.

Stem Cell Therapy Breakdown Data by Type

Autologous

Allogeneic

Stem Cell Therapy Breakdown Data by Application

Musculoskeletal Disorder

Wounds & Injuries

Cornea

Cardiovascular Diseases

Others

Request Free Sample Report athttps://www.wiseguyreports.com/sample-request/5252275-covid-19-impact-on-global-stem-cell-therapy

Table of Contents

1 Report Overview

2 Global Growth Trends by Regions

3 Competition Landscape by Key Players

4 Breakdown Data by Type (2015-2026)

5 Stem Cell Therapy Breakdown Data by Application (2015-2026)

6 North America

7 Europe

8 China

9 Japan

10 Southeast Asia

11 India

12 Central & South America

13 Key Players Profiles

14 Analyst's Viewpoints/Conclusions

NOTE: Our team is studying Covid-19 and its impact on various industry verticals and wherever required we will be considering Covid-19 footprints for a better analysis of markets and industries. Cordially get in touch for more details.

About Us:

Wise Guy Reports is part of the Wise Guy Research Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe.

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Ph: +1-646-845-9349 (US)

Ph: +44 208 133 9349 (UK)

Media ContactCompany Name: Wiseguyreports.comContact Person: Norah TrentEmail: Send EmailPhone: +1 646 845 9349, +44 208 133 9349City: PuneState: MaharashtraCountry: IndiaWebsite: https://www.wiseguyreports.com

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Tyson Reveals What Helped Him Train For Exhibition Bouts | FIGHT SPORTS – FIGHT SPORTS

By daniellenierenberg

One of the most talked-about topics today happens to be Mike Tyson appearing in shape and ready to appear in a boxing ring again. The former heavyweight champion of the world is gearing up for charity exhibition bouts thanks to Kings MMA coach Rafael Cordeiro.

Tyson (50-6, 2NC) wants to help those who are going through a tough time, like drug addicts. Relating to their situation, The 53-year-old is looking to make a difference while staying in shape. How exactly did he quickly get into fighting shape?

You know what I had done? I had stem-cell research therapy, Tyson ended up stating to Shaquille ONeal on Instagram Live, via The Sun. I feel like a different person but I cant comprehend why I feel this way. Its really wild what scientists can do.

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. The process to carry it out is via bone marrow transplantation. Several athletes from all sports have undergone the treatment, including Hines Ward, Alex Rodriguez, Kobe Bryant, Tiger Woods, and Rafael Nadal. There are specific types of therapy treatments, but it is unknown what Tyson went through.

Tyson made his professional debut in 1985 and quickly climbed up the ranks in the boxing world. In his 28th fight, Tyson knocked out Trevor Berbick in the second round to win the WBC Heavyweight Title. He became the youngest world heavyweight champion of all time at 20. Following his last fight in 2005, he ballooned up to 325 pounds.

When Shaq talked about hurting himself while hanging and working out with his kids, Tyson helped explain why. With his new regiment, Tyson is lifting weights constantly and sparring multiple times a day.

Thats just because you havent done it for a while, Tyson went on to say. If you continue to do it consistently youll be back to normal. Its just like me, I havent boxed or hit the bag for 15 years it has been three days so far and I feel incredible.

It is unknown who Tyson will be facing in his return. He has been offered, however, $1 million to fight in Australia to face some of the top stars in rugby and Australian football.

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FDA Approves AstraZeneca’s Farxiga for Heart Failure in Adults with Reduced Ejection Fraction – PharmaLive

By daniellenierenberg

FDA Approves AstraZenecas Farxiga for Heart Failure in Adults with Reduced Ejection Fraction

The U.S. Food and Drug Administration (FDA) announced on Tuesday that it has approved dapagliflozin, also known under the brand name Farxiga, for the treatment of heart failure in adults with reduced ejection fraction. The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.

AstraZenecas Farxiga is now the first in its drug class of sodium-glucose co-transporter 2 (SGLT2) inhibitors to be approved to treat adults with the New York Heart Associations functional class II-IV heart failure with reduced ejection fraction. AstraZeneca was granted with the approval of Farxiga related to heart failure by the FDA.

In a clinical trial, Farxiga appeared to improve survival and reduce the need for hospitalization in adults with heart failure and reduced ejection fraction.

To determine the efficacy of the drug, researchers looked at the number of instances of cardiovascular death, hospitalization for heart failure and urgent heart failure visits. Some trial participants were given a once-daily dose of 10mg of Farxiga, while others were given a placebo. After approximately 18 months, those who were given Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits compared to their counterparts.

Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans, said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDAs Center for Drug Evaluation and Research. This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.

Farxiga can cause side effects including dehydration, urinary tract infections and genetical yeast infections. It can also potentially result in serious cases of necrotizing fasciitis of the perineum in people with diabetes and low blood sugar when combined with insulin.

On Tuesday, BioCardia, Inc. also announced positive preclinical datasupporting its new drug application for anti-inflammatory cell therapy for heart failure. BioCardias allogenic neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) therapy appeared to improve heart function in a study. NK1R+ MSC is being marketed under the name CardiALLO.

Alexanderstock23 / Shutterstock

Researchers looked at 26 animals treated with both low dose and high dose CardiALLO in their study. Echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow all notably improved in the animals.

In light of these positive data on our allogenic NK1R+ MSC therapy, we expect to meet our internal timeline to complete our submission to the FDA for our first indication for CardiALLO, and potentially receive IND acceptance by the end of the second quarter, said BioCardia Chief Scientific Officer Ian McNiece, PhD. The MSCs that were studied are subtypes of MSC that we have delivered previously in our co-sponsored trials, which we believe have enhanced potency over MSC generated from unselected bone marrow cells. We look forward to seeing additional data from this animal study that are currently being analyzed, including histology and pathology of the heart and lungs.

BioCardia also intends to submit an IND for the use of NK1R+ MSC delivered via intravenous infusion for the treatment of Acute Respiratory Distress Syndrome caused by COVID-19.

Approximately 6.5 million adults in the U.S. are living with heart failure, according to the Centers for Disease Control and Protection. In 2017, it was a contributing cause of death in one out of eight people.

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Laila Anderson on Couch2Cure event, importance of Be the Match registry – NBCSports.com

By daniellenierenberg

Laila Anderson continues to make an impact in the lives of others one year after she became part of the Blues run to the 2019 Stanley Cup title.

On Tuesday, Anderson, who has battled HLH, a disease that causes the body to make too many immune cells, took part in an all-day livestream event called Couch2Cure to benefit Be the Match. It served as not only a fundraiser, but also a call for people to become donors for patients seeking blood stem cell matches. She was joined by FOX play-by-play man Joe Buck and Blues PA announcer Tom Calhoun.

The event was a success, raising$1.45 million and resulting in 36,000 registries to the Be the Match program.

Laila spoke with NBC Sports Kathryn Tappen on Wednesday to talk about the Couch2Cure event, the importance of the Be the Match registry, and how shes doing one year after the Blues triumph.

MORE LAILA ANDERSON: Laila introduces Blues All-Stars with gusto Blues superfan enjoying life one year after bone marrow transplant Laila meets bone marrow donor Laila gets moment with Stanley Cup

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

British Columbia Premier John Horgan has offered the NHL a place to play if the league can find a way to resume the season.

Speaking at a COVID-19 media briefing Wednesday, Horgan said he has written a letter to both NHL Commissioner Gary Bettman and NHL Players Association head Donald Fehr to let them know B.C. is a place to potentially restart the NHL assuming the games would be played without audiences, but instead played for television.

The NHL suspended its season March 12 with 189 regular-season games left.

Dr. Bonnie Henry, British Columbias provincial health officer, was asked Monday about Vancouver hosting NHL games with no fans and said: These are the types of things that we need to think about.

Ontario Premier Doug Ford said Tuesday the Maple Leafs parent company, MLSE, has been in contact with the province about the possibility of Toronto serving as a hockey pod for teams as well. Alberta Premier Jason Kenney and Bettman spoke last month about Edmonton as another potential hub city.

Welcome to the PHT Morning Skate, a collection of links from around the hockey world. Have a link you want to submit? Email us atphtblog@nbcsports.com.

A really nice read about ex-Blackhawks president John McDonoughs friendship with 11-year-old Cammy Babiarz, who is unable to walk or talk because of Rett Syndrome a rare developmental disorder. [Midway Minute]

It didnt last very long, but at one point in time Michael Jordan was a minority owner of the Capitals. [ESPN]

Economies are beginning to open up again, so too are hockey rinks in the U.S. [The Hockey News]

Georges Laraque opens about his up and down relationship with his father. [Vice]

How the 2011-12 Kings became unlikely Stanley Cup champions. [The Score]

Comparing Brady Tkachuks early days in the NHL to that of Mark Stones. [Silver Seven Sens]

What if some of NHLs all-time best hadnt run into historic dynasties? [Sportsnet]

Looking ahead to whats expected to be an intriguing 2022 NHL draft class. [Stephen Ellis]

Finally, the Wild music video you were looking for:

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

After pulling the plug on the 2019-20 season in March, the KHL has decided there will be no champion and the Gagarin Cup will not be awarded for the first time in league history.

Due to this decision, the league has equally ranked the eight teams that advanced to the second round of the playoffs:Ak Bars Kazan,Barys Nur-Sultan,CSKA Moscow,Dynamo Moscow,Jokerit Helsinki,Salavat Yulaev Ufa,Sibir Novosibirsk, and SKA St. Petersburg.

From the KHL:

With the season incomplete, there is no way that a Gagarin Cup winner and other prize winners can be fairly chosen based on the results of the regular season. To announce a champion based on the regular season and one round of the playoffs would violate the sporting integrity of the competition.

The Russian Hockey Federation has drawn up a separate procedure to determine the Russian Champion for the 2019-20 season, and to award silver and bronze medals to the second and third-placed teams. This proposal will be submitted to the KHL Board of Directors for approval.

The Gagarin Cup playoffs were halted in the conference semifinals after Jokerit and Barys pulled out due to the coronavirus pandemic. Originally, the KHL was planning for a one-week break to come up with a new format for the four remaining teams. They later chose to end the season completely.

Im sure that the league has taken a fair and balanced decision in this difficult situation, said KHL president Alexei Morozov. This was the only choice that respects our sporting principles. For the first time in history, the KHL season had to be interrupted and ultimately curtailed. That was a tough, but essential decision, dictated by the need to protect the health of the nation.

MORE: Bill Peters signs two-year deal to coach KHLs Avtomobilist

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

Brendan Leipsic of the Capitals has apologized for comments made on social media that were leaked online Wednesday. Panthers prospect Jack Rodewald was also in the Instagram group chat where remarks were made about the appearances of Meaghan Pearson, whose husband, Tanner, plays for the Canucks, Lauren Kyle, the girlfriend of Oilers forward Connor McDavid, and other women.

Yesterday my friends Instagram account was hacked and an individual circulated images that are representative of private conversations I was a part of, Leipsic wrote in an apology note posted on Twitter. I fully recognize how inappropriate and offensive these comments are and sincerely apologize to everyone for my actions. I am committed to learning from this and becoming a better person by taking time to determine how to move forward in an accountable, meaningful way. I am truly sorry.

The NHL released a statement of their own stating they will address this with the players involved.

The National Hockey League strongly condemns the misogynistic and reprehensible remarks made by players Brendan Leipsic and Jack Rodewald in a private group chat that has surfaced on social media. There is no place in our League for such statements, attitudes and behavior, no matter the forum. We will address this inexcusable conduct with the clubs and players involved.

Leipsic, who has played 61 games with the Capitals this season, is on his fifth team in five years since entering the NHL. His current team wrote in a statement,We are aware of the unacceptable and offensive comments made by Brendan Leipsic in a private conversation on social media. We will handle this matter internally.

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

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Laila Anderson on Couch2Cure event, importance of Be the Match registry - NBCSports.com

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Cell Therapy Manufacturing Market 2020 Coronavirus (Covid-19) Business Impact Size Will Escalate Rapidly in the Near Future 3w Market News Reports -…

By daniellenierenberg

The global Cell Therapy Manufacturing Market research report thoroughly explains each and every aspect related to the Cell Therapy Manufacturing Market, which facilitates the reports reader to study and evaluate the upcoming market trend and execute the analytical data to promote the business. The growth trend forecasted on account of thorough examination offers in-depth information regarding the global Cell Therapy Manufacturing Market. A pathway of development is offered by the market to the several connected networks of businesses under it, which include different firms, industries, organizations, vendors, distributors, and local manufacturers too. All the key Cell Therapy Manufacturing Market players compete with each other by offering better products and services at a reasonable price in order to grab significant share at the regional and global level market.

Cell therapy is one of the most promising healthcare procedure for restoration of damaged tissue. Cell therapies have huge potential for the wide range of disease treatment including tissue degradation, immune deficiency, metabolic disorders, and cancer. Cell therapy are categorized into two types allogeneic (cells from third party donor) and autologous (cells from ones own body). Cell therapy has gained significant traction in recent past and currently it under commercial development. Main objective of cell therapy is to re-establish the lost function of tissues and cells rather than to produce a new organ. Some cell therapies have been established and permitted for clinical trial. For instance, in 2013 a stage 2 clinical trial was completed for transplantation of bone marrow derived stem cells in affected knee by rheumatoid arthritis. The growth of this technique is also increased due to involvement of the government agencies. For instance, innovate U.K. 2014 report showed that government agreed to fund US$15.3 million in cell therapy manufacturing market.ription

Get a Sample Copy of this Report: https://www.coherentmarketinsights.com/insight/request-sample/1728

This report sample includesBrief Introduction to the research report.Table of Contents (Scope covered as a part of the study)Top players in the marketResearch framework (presentation)Research methodology adopted by Coherent Market Insights

The report incorporates an estimated impact of strict standards and regulations set by the government over the market in the upcoming years. The market report also comprises exhaustive research done using several analytical tools such as SWOT analysis to identify the market growth pattern.

Top Manufacturers in GlobalCell Therapy ManufacturingMarket Includes:Pharmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

Regions & Countries Mentioned In The Cell Therapy Manufacturing Market Report:

North America ( United States)

Europe ( Germany, France, UK)

Asia-Pacific ( China, Japan, India)

Latin America ( Brazil)

The Middle East & Africa

Key Highlights of the Table of Contents:

Cell Therapy Manufacturing Market Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global market, years considered, and study objectives. Furthermore, it tuches the segmentation study provided in the report on the basis of the type of product and applications.

Cell Therapy Manufacturing Market Executive Summary: This section emphasizes on the key studies, market growth rate,Competitive landscape, market drivers, trends, and issues.

Cell Therapy Manufacturing Market Production by Region: The report provides information related to import and export, production, revenue, and key players of all regional markets studied are covered in this section.

Cell Therapy Manufacturing Market Profile of Manufacturers: Analysis of each market player profiled is detailed in this section. This also provides SWOT analysis, products, production, value, capacity, and other vital factors of the individual player.

Buy This Complete A Business Report: https://www.coherentmarketinsights.com/insight/buy-now/1728

Table of Contents

Report Overview:It includes the Cell Therapy Manufacturing market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.

Executive Summary:This section of the report gives information about Cell Therapy Manufacturing market trends and shares, market size analysis by region and analysis of global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.

Profiles of International Players:Here, key players of the Cell Therapy Manufacturing market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.

Regional Study:All of the regions and countries analyzed in the Cell Therapy Manufacturing market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.

An Overview of the Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus. As authorities encourage social distancing and consumers stay indoors, several businesses are hit. However, coherent, coordinated, and credible policy responses are expected to offer the best chance at limiting the economic fallout.

National governments and international bodies are focused on adopting collaborative efforts to encourage financial institutions to meet the financial needs of customers and members affected by the coronavirus. However, there are some sectors that have remained unscathed from the impact of the pandemic and there are some that are hit the hardest.

We, at Coherent Market Insights, understand the economic impact on various sectors and markets. Using our holistic market research methodology, we are focused on aiding your business sustain and grow during COVID-19 pandemics. With deep expertise across various industries-no matter how large or small- and with a team of highly experienced and dedicated analysts, Coherent Market Insights will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.

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NHL offered place to play in British Columbia – NBCSports.com

By daniellenierenberg

British Columbia Premier John Horgan has offered the NHL a place to play if the league can find a way to resume the season.

Speaking at a COVID-19 media briefing Wednesday, Horgan said he has written a letter to both NHL Commissioner Gary Bettman and NHL Players Association head Donald Fehr to let them know B.C. is a place to potentially restart the NHL assuming the games would be played without audiences, but instead played for television.

The NHL suspended its season March 12 with 189 regular-season games left.

Dr. Bonnie Henry, British Columbias provincial health officer, was asked Monday about Vancouver hosting NHL games with no fans and said: These are the types of things that we need to think about.

Ontario Premier Doug Ford said Tuesday the Maple Leafs parent company, MLSE, has been in contact with the province about the possibility of Toronto serving as a hockey pod for teams as well. Alberta Premier Jason Kenney and Bettman spoke last month about Edmonton as another potential hub city.

Laila Anderson continues to make an impact in the lives of others one year after she became part of the Blues run to the 2019 Stanley Cup title.

On Tuesday, Anderson, who has battled HLH, a disease that causes the body to make too many immune cells, took part in an all-day livestream event called Couch2Cure to benefit Be the Match. It served as not only a fundraiser, but also a call for people to become donors for patients seeking blood stem cell matches. She was joined by FOX play-by-play man Joe Buck and Blues PA announcer Tom Calhoun.

The event was a success, raising$1.45 million and resulting in 36,000 registries to the Be the Match program.

Laila spoke with NBC Sports Kathryn Tappen on Wednesday to talk about the Couch2Cure event, the importance of the Be the Match registry, and how shes doing one year after the Blues triumph.

MORE LAILA ANDERSON: Laila introduces Blues All-Stars with gusto Blues superfan enjoying life one year after bone marrow transplant Laila meets bone marrow donor Laila gets moment with Stanley Cup

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

Welcome to the PHT Morning Skate, a collection of links from around the hockey world. Have a link you want to submit? Email us atphtblog@nbcsports.com.

A really nice read about ex-Blackhawks president John McDonoughs friendship with 11-year-old Cammy Babiarz, who is unable to walk or talk because of Rett Syndrome a rare developmental disorder. [Midway Minute]

It didnt last very long, but at one point in time Michael Jordan was a minority owner of the Capitals. [ESPN]

Economies are beginning to open up again, so too are hockey rinks in the U.S. [The Hockey News]

Georges Laraque opens about his up and down relationship with his father. [Vice]

How the 2011-12 Kings became unlikely Stanley Cup champions. [The Score]

Comparing Brady Tkachuks early days in the NHL to that of Mark Stones. [Silver Seven Sens]

What if some of NHLs all-time best hadnt run into historic dynasties? [Sportsnet]

Looking ahead to whats expected to be an intriguing 2022 NHL draft class. [Stephen Ellis]

Finally, the Wild music video you were looking for:

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

After pulling the plug on the 2019-20 season in March, the KHL has decided there will be no champion and the Gagarin Cup will not be awarded for the first time in league history.

Due to this decision, the league has equally ranked the eight teams that advanced to the second round of the playoffs:Ak Bars Kazan,Barys Nur-Sultan,CSKA Moscow,Dynamo Moscow,Jokerit Helsinki,Salavat Yulaev Ufa,Sibir Novosibirsk, and SKA St. Petersburg.

From the KHL:

With the season incomplete, there is no way that a Gagarin Cup winner and other prize winners can be fairly chosen based on the results of the regular season. To announce a champion based on the regular season and one round of the playoffs would violate the sporting integrity of the competition.

The Russian Hockey Federation has drawn up a separate procedure to determine the Russian Champion for the 2019-20 season, and to award silver and bronze medals to the second and third-placed teams. This proposal will be submitted to the KHL Board of Directors for approval.

The Gagarin Cup playoffs were halted in the conference semifinals after Jokerit and Barys pulled out due to the coronavirus pandemic. Originally, the KHL was planning for a one-week break to come up with a new format for the four remaining teams. They later chose to end the season completely.

Im sure that the league has taken a fair and balanced decision in this difficult situation, said KHL president Alexei Morozov. This was the only choice that respects our sporting principles. For the first time in history, the KHL season had to be interrupted and ultimately curtailed. That was a tough, but essential decision, dictated by the need to protect the health of the nation.

MORE: Bill Peters signs two-year deal to coach KHLs Avtomobilist

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

Brendan Leipsic of the Capitals has apologized for comments made on social media that were leaked online Wednesday. Panthers prospect Jack Rodewald was also in the Instagram group chat where remarks were made about the appearances of Meaghan Pearson, whose husband, Tanner, plays for the Canucks, Lauren Kyle, the girlfriend of Oilers forward Connor McDavid, and other women.

Yesterday my friends Instagram account was hacked and an individual circulated images that are representative of private conversations I was a part of, Leipsic wrote in an apology note posted on Twitter. I fully recognize how inappropriate and offensive these comments are and sincerely apologize to everyone for my actions. I am committed to learning from this and becoming a better person by taking time to determine how to move forward in an accountable, meaningful way. I am truly sorry.

The NHL released a statement of their own stating they will address this with the players involved.

The National Hockey League strongly condemns the misogynistic and reprehensible remarks made by players Brendan Leipsic and Jack Rodewald in a private group chat that has surfaced on social media. There is no place in our League for such statements, attitudes and behavior, no matter the forum. We will address this inexcusable conduct with the clubs and players involved.

Leipsic, who has played 61 games with the Capitals this season, is on his fifth team in five years since entering the NHL. His current team wrote in a statement,We are aware of the unacceptable and offensive comments made by Brendan Leipsic in a private conversation on social media. We will handle this matter internally.

Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.

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11 Skincare Products To Try Now Injectables Are Off The Cards – British Vogue

By daniellenierenberg

Youve probably seen those before-and-after quarantine memes, the ones featuring faces or more specifically, lips that have undergone a drastic change in shape in the absence of access to an aesthetician. Exaggerated they might be, but it is true that lockdown has left an injectable-shaped hole in some of our lives, and whether youre into them or not, our newly facial-free (and less-than-active) lifestyles are wreaking a certain amount of havoc on our skin anyway. For those who have regular in-clinic treatments, lockdown can mean that lines start to show, full lips diminish, cheeks depress and sunken eye sockets and dark circles re-appear, says aesthetic doctor Dr Sophie Shotter, who has temporarily shuttered her clinic and returned to the NHS frontline to join the fight against Covid-19. And, while the issue might seem trivial in light of everything else going on in the world, it is possible to harness the power of intelligent skincare to help mimic the effects of filler and Botox in lieu of the real thing. Dr Shotter shares her tips here.

Filler is routinely administered to add volume to the skin, usually in the face, says Shotter, who explains that its made from hyaluronic acid, a molecule we should all be utilising in our skincare routines to help soften fine lines. One of the best serums for the job is SkinCeuticals HA Intensifier, which boosts hyaluronic acid levels in the skin, making it look and feel firm, plump and hydrated. Alternatively, try LOrals Revitalift Filler Hyaluronic Acid for a more affordable option.

To smooth skin, Shotter also recommends BioEffect EGF Serum, which boosts skin thickness and collagen levels in the skin, meaning fewer wrinkles and a healthy glow. And finally, look to SkinBetter Science AlphaRet Overnight Cream to reap the benefits of prescription strength vitamin A (otherwise known as retinol): Retinol is the ultimate age management molecule that increases collagen levels, she says.

If youve had Botox before, you will know that its a toxin injected where there are dynamic lines to relax them and remove creases within the skin, says Shotter. There are products that mimic its effects: Meder Skincare Myo-Fix Concentrate, is full of muscle-relaxing peptides that work to block the nerve communicating with the muscle. Although it might sound daunting, its totally safe to use, and Shotter recommends regular and sustained use for the best results. Another great product to use if you usually have Botox administered superficially to regulate oil production is Institut Esthederms Pure System Pore Refiner Concentrate it is silicone based so refines their appearance beautifully.

Used religiously, there are products that can help to lift and plump the lips, although, like all of the products listed here, they wont have effects on a par with the treatment itself. One of the best to try is Fillerinas Lip Volume Grade 3, which contains six different hyaluronic acid molecules of varying weights and sizes, to deeply hydrate lips and give a fuller effect with continual use. Shotter also recommends a brilliant lip balm. Medik8s Mutiny Squalane Lip Balm helps to nourish and heal the lips, drawing moisture to the area to give them a plumper, more hydrated look, she says, adding that its important to use SPF to protect them from collagen-depleting UV rays. Protecting the health of the lips will help them stay plump and full.

Filler is often strategically placed to fill the hollows under the eyes, to refresh and hydrate and to lift dark circles, says Shotter. A (plant-based) stem cell serum, like Dr Levy Intense Stem Cell Eye Booster Concentrate, will boost the thickness of the delicate under eye skin, plus it also contains retinol and antioxidants to smooth fine lines and brighten the area. MGC Dermas CBD Stem Cells and Peptides Eye Cream is a brilliant option too, thanks to firming peptides, hyaluronic acid and calming CBD.

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FDA Approves Tabrecta, the First Targeted Drug for Patients with Non-Small Cell Lung Cancer and MET exon 14 – Curetoday.com

By daniellenierenberg

Tabrecta (capmatinib) will treat patients with metastatic non-small cell lung cancer that has a mutation leading to MET exon 14 skipping. The drug is the first targeted option for patients with lung cancer and this type of mutation.

Tabrecta is the first therapy approved by the FDA specifically to treat NSCLC with mutations that lead to epithelial-mesenchymal transition (EMT), which is MET exon 14 skipping.

Tabrecta is approved for patients who are new to treatment and also those who have received previous therapies, regardless of prior treatment type.

Along with the drug approval, the FDA gave the green light to a companion diagnostic, the FoundationOne CDx assay, which can identify these mutations in patients.

In epithelialmesenchymal transition(EMT), the cells that line an organ lose their polarity and ability to adhere to other cells, giving them the ability to invade tissues and organs. MET exon 14 skipping means that a segment of RNA that should prompt the production of a specific protein stops sending those messages.

The spread of cancer consists of a sequential series of events and MET exon 14 skipping is recognized as a critical event in this process, the FDA stated in a press release about the approval. Mutations leading to MET exon 14 skipping are found in 3% to 4% of patients with lung cancer, the agency stated.

Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations with drugs being developed to target these specific groups, said Dr. Richard Pazdur, director of the FDAs Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDAs Center for Drug Evaluation and Research, in the release.

Taken orally, Tabrecta works by blocking a key protein that drives metastatic NSCLC in these patients. The FDA approved it based on the results of a clinical trial involving patients with NSCLC who had mutations leading to MET exon 14 skipping; their tumors did not express the proteins EGFR or ALK.

The evaluated study population included 28 patients who had never undergone treatment for NSCLC and 69 previously treated patients. The overall response rate (ORR; the percentage of participants who experienced a prespecified amount of tumor shrinkage) for the 28 participants was 68%, with 4% having a complete response and 64% having a partial response.

The ORR for the 69 participants was 41%, with all having a partial response. Of the responding participants who had never undergone treatment for NSCLC, 47% had a duration of response lasting 12 months or longer compared with 32.1% of the responding participants who had been previously treated.

Common side effects for patients taking Tabrecta included swelling of the legs, nausea, fatigue, vomiting, shortness of breath and decreased appetite.

Tabrecta may cause serious side effects including scarring or inflammation of the lungs. It may also cause damage to liver cells or harm a developing fetus or newborn baby. Patients may be more sensitive to sunlight when they take Tabrecta and should take precautions to cover their skin and use sunscreen.

Tabrecta was approved under theFDAs accelerated approval, breakthrough designation and priority review programs, which provide for a quicker review of drugs that treat serious or life-threatening diseases and represent a meaningful advantage over existing treatments.

Continued approval for this indication may be contingent upon verification of these results in confirmatory clinical trials.

Check back for what you need to know regarding this approval.

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FDA Approves Tabrecta, the First Targeted Drug for Patients with Non-Small Cell Lung Cancer and MET exon 14 - Curetoday.com

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Anglo African Oil & Gas mystified by sharp share price hike – Proactive Investors UK

By daniellenierenberg

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Researchers Convert Astrocytes to Neurons In Vivo to Treat… : Neurology Today – LWW Journals

By daniellenierenberg

Article In Brief

A mouse study shows that select transcription factors to the striatum can effectively and safely convert astrocytes to neurons to treat Huntington's disease.

Delivering two transcription factors to the striatum in a mouse model of Huntington's disease can safely convert astrocytes into neurons with high efficiency, according to a new study in the February 27 issue of Nature Communications.

The neurons grow to and wire up with their targets in the globus pallidus and substantia nigra, and remaining astrocytes proliferate to replace those that have been converted. The treatment extends the lifespan and improves the motor behavior of the mice.

What is exciting about this study is that the authors have clearly made cells that do what they are supposed to do, namely replace dying neurons in existing circuits, said Roger Barker, PhD, professor of clinical neuroscience and honorary consultant in neurology at the University of Cambridge and at Addenbrooke's Hospital, who was not involved in the work. I think the challenge of scaling up this strategy to the human Huntington's disease brain is pretty substantial, but nonetheless, this is an important discovery.

The new study, led by Gong Chen, PhD, builds on discoveries beginning in the mid-2000s showing that a small number of exogenously applied transcription factors could transform skin fibroblasts into stem cells, which could then be further converted to become virtually any cell type. That discovery was quickly followed by advances in direct reprogramming, in which one cell type is directly converted into another, skipping the stem cell intermediate.

Most of that work has taken place in vitro, and most attempts to use the strategy therapeutically have depended on transplantation of stem cells or newly converted cells.

We tried stem cell transplants to the mouse brain 10 years ago, but we couldn't find a lot of functional neurons, said Dr. Chen, professor at Guangdong-Hong Kong-Macau Institute of CNS Regeneration of Jinan University in Guangzhou, China.

It was also clear that anything you do in vitro, you eventually have to transplant, and that didn't seem to be a very promising technology, so I said, Let's try this in vivo, and put transcriptions factors directly into the mouse brain.

Dr. Chen initially tried introducing the transcription factor neurogenin 2, but the efficiency of conversion of astrocytes to neurons was very low, so he turned to the transcription factor NeuroD1, which Dr. Chen's group had previously shown could convert astrocytes into excitatory glutamatergic neurons.

In the current study, in order to generate GABAergic neurons, the team combined NeuroD1 with another transcription factor, D1x2, based on previous work showing its importance for generating GABAergic neurons.

The team packed the genes for the transcription factors into a recombinant adeno-associated virus vector (rAAV 2/5) and used an astrocyte-specific promoter to drive the transgene expression so that it preferentially expresses in astrocytes. They first injected the vector into the normal mouse striatum.

Surprisingly, this strategy worked very well at high efficiency, Dr. Chen said. After seven days, all transfected cells expressed astrocyte markers, indicating a high level of specificity in the vector. Of those cells, 81 percent co-expressed the two transcription factors. By 30 days, 73 percent of the cells expressing the transcription factors now expressed neuronal, rather than astrocytic markers, and were primarily GABAergic in character.

Next, Dr. Chen asked whether the remaining astrocytes could repopulate to replace those lost to conversion. Using immunostaining for astrocytes and neurons, as well as other techniques, the team found that the neuron/astrocyte ratio was unchanged, and that some remaining astrocytes could be found at different stages of cell division, suggesting the process facilitated astrocyte proliferation.

Dr. Chen then turned to the R6/2 mouse, the most common mouse model of Huntington's disease. He treated mice at 2 months of age, just as they began to show motor symptoms

As in the wild-type mice, astrocytes were converted to GABAergic neurons at high efficiency without altering the neuron/astrocyte ratio. The researchers observed similar results in a less-severe HD mouse model as well. Treated mice had only about half the degree of striatal atrophy as untreated mice. The converted neurons still contained aggregated huntingtin protein, but less than in native neurons, and similar to the reduced amount found in astrocytes in the mouse brain.

The real test of any cell therapy in neurodegenerative disease is whether the new cells can link into the existing circuits and provide functional benefit, feats that have been hard to achieve with transplanted fetal cells or stem cells.

Examining striatal slices from the treated mice, Dr. Chen found that the converted neurons displayed electrical properties largely identical to those of normal neurons, including resting potential, action potential threshold, firing amplitude, and firing frequency. They integrated into local circuits and behaved similarly to the native neurons around them. By tracking a marker contained in the AAV gene construct, they showed that converted neurons projected axons to the two basal ganglia targets of medium spiny neurons in the striatum, the globus pallidus and the substantia nigra.

Finally, Dr. Chen found that stride length and travel distance were both significantly improved in treated mice, though still falling below those of wild-type mice, and lifespan was significantly extended.

There were no hints of tumors in the mice, Dr. Chen noted. He suggested that in situ conversion is likely intrinsically safer in this regard than using stem cell-derived neurons, since a proliferative astrocyte is being converted into a non-proliferative neuron, with no residual pool of unconverted and potentially tumorigenic stem cells. We are actually reducing the tumor risk, he said.

Why the converted neurons developed appropriate neuronal connections is an important unanswered question, Dr. Chen said. He suggested there were two important factorsfirst, the astrocytes from which they arose are likely developmentally related to neighboring neurons, and thus may express similar position markers that help guide them to the right targets, just like the native neurons. Second, those remaining neurons may also provide guide tracks for the newly growing axons.

This conversion technique is not limited to Huntington's disease, he stressed, noting that his team last year published a paper showing promise in ischemic stroke, and work is underway to test its potential in Alzheimer's disease, Parkinson's disease, spinal cord injury, and ALS. He is also moving on to testing in non-human primates, setting the stage for eventual human trials.

I think eventually we will want to correct the Huntington's mutation as well, Dr. Chen said, for instance by using CRISPR, but he pointed out that while that strategy can repair diseased neurons, it cannot make new ones, like astrocyte-to-neuron conversion can.

This study is really elegantly done, commented Veronica Garcia, PhD, who has studied astrocytes derived from induced pluripotent stem cells from Huntington's disease patients as a postdoctoral scientist working with Clive Svendsen, PhD, in the Regenerative Medicine Institute at Cedars-Sinai Medical Center in Los Angeles.

The conversion efficiency is similar between wild-type and disease models, suggesting that the disease process is not interfering with the conversion, she said.

Astrocyte depletion does not seem to be a problem, at least in the short term, but Dr. Garcia noted there is a limit on the number of divisions astrocytes appear able to undergo, after which they lose the ability to proliferate. That may be a problem for chronic treatment, she suggested. Nonetheless, these results really look promising for therapeutic development.

The concept of trying to reprogram cells in situ to take on the phenotype of the cells that are lost is not new, commented Dr. Barker, but being able to do it with any degree of efficiency, to make enough cells to make a significant difference, has been problematic. For that reason, and because the cells grow to their target sites and make connections, these results are surprising.

A major hurdle for clinical trials, he noted, will be scaling up to the human striatum, which has approximately 100 times the volume of that in the mouse. Delivering the vector to such a large volume will be a significant challenge, he said, along with determining whether this approach will really work in a disease that affects many different brain structures such as in HD.

Dr. Chen is co-founder of NeuExcell Therapeutics Inc, which will develop clinical trials in the future. Drs. Barker and Garcia disclosed no conflicts.

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Researchers Convert Astrocytes to Neurons In Vivo to Treat... : Neurology Today - LWW Journals

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Temple University: Spinal Cord Injury and Optic Nerve Damage Repaired With Growth-Regulating Molecule – Gilmore Health News

By daniellenierenberg

Researchers at Temple University have made a discovery that raises hope of restored functions for people with spinal cord injuries and other related issues.

In a study published in Molecular Therapy, researchers said they were able to regenerate neurons in mice that had spinal cord injury and optic nerve damage. They succeeded in restoring lost functions in the animals with the aid of a molecule called Lin28.

Several thousands of people suffer permanent losses of motor function and sensation due to spinal cord injury and similar conditions every year. These are results of severe damage or separation of axons.

Humans can regenerate most of the tissues in their bodies when damaged. Axons, however, fall among key body components that they are unable to redevelop when damaged.

Read Also: University of Freiburg Identifies the Neurons Responsible for Rapid Eye Movements During Sleep

The new research by the Temple University scientists interestingly shows that Lin28 helps to mend axons. With the aid of the molecule, mice showed gains in sensation and recovery of motor function.

Our findings show that Lin28 is a major regulator of axon regeneration and a promising therapeutic target for central nervous injuries, said lead researcher Dr. Shuxin Li, MD, PhD.

The regenerative capacity of Lin28 was observed when it was expressed at levels higher than normal.

It was the first time scientists showed the potential of the molecule to help repair spinal cord injuries.

Axons are nerve fibers that project from neurons. They form networks that help to pass signals from the brain to different parts of the body. These long nerve fibers literally serve as communication cables.

The brain, for instance, depends on axons to be able to communicate with muscles. It is this interaction that enables movement in response to stimuli.

When axons are severed as a result of an injury or accident, sensation and motor function losses result. These changes last for the rest of a persons life since the structures do not regenerate.

In the current research, scientists decided to explore the ability of Lin28 to regrow neurons. They developed an interest in this because of how it determines whether or not stem cells differentiate.

The researchers developed a model involving over-expression of the focal molecule in certain tissues in mice. They put the animals in different groups containing those having a spinal cord injury or optic nerve damage after becoming adults.

Also, the team had a different group of mice with normal levels of Lin28 expression as well as spinal cord or optic nerve injuries. To examine tissue repair effects, the animals were injected with a viral vector that increases the expression of the molecule.

Expressions of Lin28 above normal levels promoted regeneration of axons in all the animals.

Lin28 injections led to axons extending up to 3 mm away from the point of severance or damage in animals with spinal cord injury. Axons grew again all along the whole length of the optic nerve tract.

The use of molecule injections proved to be the most effective means of restoring damaged axons.

When the researchers assessed the walking and sensory capabilities of the animals, they found that Lin28 therapy led to great improvements.

At the moment, there is no restorative treatment for people with injuries involving the spinal cord or optic nerve tracts, which link to the retina.

Li said the level of axon regeneration seen in the study could be highly significant in clinical terms. The professor of anatomy and cell biology revealed that one of his immediate plans was finding a means of making Lin28 helpful to human patients.

Read Also: UC Berkeley Researchers Restore Vision in Mice Through Gene Insertion

He and colleagues need to create a carrier (or vector) for the molecule that would improve its expression when injected. They need to find a means of precisely targeting damaged axons with the treatment.

The researchers also planned to learn more about the Lin28 signaling pathway. Li expressed a suspicion that the molecule possibly uses more than one pathway to promote repair.

To support growth, the molecule seems to work with several others that could potentially be combined with it for more effective therapy.

References

https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(20)30191-X

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Spinal Cord Trauma Treatment Market to Register CAGR 3.7% Growth in Revenue During the Forecast Period 2025 – Jewish Life News

By daniellenierenberg

Spinal Cord Trauma Treatment Market: Global Industry Analysis 2012 2016 and Forecast 2017 2025is the recent report of Persistence Market Research that throws light on the overall market scenario during the period of eight years, i.e. 2017-2025. According to this report, Globalspinal cord trauma treatment marketis expected to witness significant growth during the forecast period.

This growth is expected to be primarily driven by increasing incidence of spinal cord trauma, and increasing government support to reduce the burden of spinal cord injuries. Additionally, development of nerve cells growth therapy is expected to boost the market in near future.

What the report encloses for the readers:

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Company Profiles

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The global market for spinal cord trauma treatment is is estimated to be valued at US$ 2,276.3 Mn in terms of value by the end of 2017. The global spinal cord trauma treatment market is expected to expand at a CAGR of 3.7% over the forecast period to reach a value of US$ 3,036.2 Mn by 2025end.

Global Spinal Cord Trauma Treatment Market: Trends

Global Spinal Cord Trauma Treatment Market: Forecast by End User

On the basis of end user, the global spinal cord trauma treatment market is segmented into hospitals and trauma centers. Hospitals segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period.

Hospitals and trauma centers segments are expected to approximately similar attractive index. Hospitals segment accounted for 53.2% value share in 2017 and is projected to account for 52.5% share by 2025 end.

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Global Spinal Cord Trauma Treatment Market: Forecast by Injury Type

On the basis of injury type, the global spinal cord trauma treatment market is segmented into complete spinal cord injuries and partial spinal cord injuries.

Partial spinal cord trauma treatment segment is expected to show better growth than the completed spinal cord treatment segment due to higher growth in the incidence rate of partial spinal cord trauma than the complete spinal cord trauma. With US$ 1,870.3 Mn market value in 2025, this segment is likely to expand at CAGR 3.8% throughout the projected period.

Global Spinal Cord Trauma Treatment Market: Forecast by Treatment Type

On the basis of treatment type, the global spinal cord trauma treatment market is segmented into corticosteroid, surgery, and spinal traction segments.

Surgery segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period. Surgery segment is the most attractive segment, with attractiveness index of 2.6 over the forecast period.

Global Spinal Cord Trauma Treatment Market: Forecast by Region

This market is segmented into five regions such as North America, Latin America, Europe, APAC and MEA. Asia-Pacific account for the largest market share in the global spinal cord trauma treatment market.

Large patient population due to the high rate of road accidents and crime is making the Asia Pacific region most attractive market for spinal cord trauma treatment. On the other hand, MEA and Latin America is expected to be the least attractive market for spinal cord trauma treatment, with attractiveness index of 0.3 and 0.5 respectively over the forecast period.

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Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy | DNA RNA and Cells | News Channels -…

By daniellenierenberg

DetailsCategory: DNA RNA and CellsPublished on Wednesday, 06 May 2020 18:08Hits: 268

CARLSBAD, CA, USA I May 06, 2020 ILineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that updated results from a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were published online via the ARVOLearn platform as part of the 2020 Association for Research in Vision and Ophthalmology (ARVO) Meeting. The presentation entitled, Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results (Abstract # 3363764), was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. Dr. Riemanns presentation is available on the Media page of the Lineage website. Lineage will also host a live call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results of treatment with OpRegen. Interested parties can access the call on the Events and Presentations section of Lineages website.

This update is significant as it builds on our earlier reports of gains in visual acuity and provides a more comprehensive picture of treatment with OpRegen for dry AMD, with meaningful improvements in the progression of geographic atrophy, visual acuity, and reading speed observed in our first Cohort 4 patient and first Orbit SDS with thaw-and-inject formulation dosed patient, stated Brian M. Culley, Lineage CEO. As dry AMD is a slow and progressive disease, it takes many months to observe changes to retinal anatomy or visual acuity. With the benefit of longer follow-up, we now can report that some OpRegen treated patients are able to see better, have less growth in their area of GA, and are able to read faster, all of which represent significant enhancements to vision and quality of life metrics. In addition to these individual results, the pooled data continues to suggest a treatment effect in both visual acuity and GA progression. Notably, we also are reporting additional evidence that OpRegen cells remain present for at least 4 years and hope that longer follow-up periods will reinforce a growing body of evidence that OpRegen is well-tolerated and can provide sustained and clinically meaningful benefits with a single dose of RPE cells. Our near-term objective is to treat and monitor the final four patients in Cohort 4 of the current study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market.

As a principal investigator on the OpRegen clinical study, I am excited to present this most recent update, where all Cohort 4 patients treated with OpRegen had improved Best Corrected Visual Acuity up to one year or at their last visit, demonstrating a substantial treatment response, stated Christopher D. Riemann, M.D. The pooled Cohort 4 data demonstrate a significant, greater than 10-letter sustained visual acuity improvement over the entire followup period. Reading center assessments of GA also suggest a reduction in GA progression in the OpRegen treated eye when compared to fellow eye in Cohort 4. I am encouraged by the results observed in patients treated to date with OpRegen and I look forward to dosing patients in this study at CEI.

KOL Call Information and Webcast

Lineage will host a conference call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineages website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the Lineage Cell Therapeutics Call. A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through May 19, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6597936.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

SOURCE: Lineage Cell Therapeutics

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Mrieux Equity Partners and Korys Announce the Launch of OMX Europe Venture Fund, Dedicated to Venture Investment Within the Healthcare and Nutrition…

By daniellenierenberg

LYON, France & HALLE, Belgium--(BUSINESS WIRE)--Mrieux Equity Partners and Korys announce the launch of a new investment platform in Venture Capital to support innovative companies in the healthcare and nutrition sectors, in Europe and North America.

OMX Europe Venture Fund FPCI (OMX Europe) was launched with a significant financial commitment representing more than two thirds of the target size of the fund (EUR 90 million) with the support of Korys and Mrieux Dveloppement as sponsors and the contribution of new third party subscribers. The fund will benefit from the solid expertise and network of its sponsors and will be operated by a dedicated team covering direct investments in Venture Capital.

OMX [-miks] refers to a field of study in biology ending in -omics, such as genomics, proteomics, metabolomics or microbiomics. The promise of precision medicine and a biology-led industrial revolution hinge on the ability to reduce the complex interconnections of large, multi-omic data sets into useful products, services and information to enable a more personalized healthcare and nutrition.

The crisis caused by COVID-19 has raised significant public and government awareness around the importance of biology, for a better understanding of infectious diseases but also for providing adequate solutions in the field of prevention, diagnostic and therapeutic intervention. The OMX Europe investment fund focuses on entrepreneurs and life science companies driving breakthroughs in this field at international level, ultimately contributing to a better and cost-effective healthcare while also addressing global challenges.

A number of investments have already been completed by the fund:

OMX Europe will be managed by Mrieux Equity Partners in Europe, with the operational support of Korys Life Science team as a key advisor to the fund. Mrieux Equity Partners currently employs four FTEs dedicated to venture investment and plans to expand its team over the coming months. To add additional geographic and sector expertise a strategic partnership was recently established with a team of senior business executives who have co-invested on several venture deals in the United States with Mrieux Equity Partners over the last ten years. The US-based OMX Ventures investment team, composed of Craig Asher, Nick Haft and Dan Fero, with the support of Paul Conley, operating as Senior Advisor to the fund, will bring an outstanding track record and deep experience in the life science sector.

The American OMX Ventures team have established OMX Ventures Fund I (OMX US) in the US to support innovative companies, with a similar investment strategy to that of the OMX Europe fund and a privileged right of co-investment with OMX Europe. Targeting at least USD 100 million, OMX US has recently completed an initial closing and secured over two thirds of the funding for OMX Ventures Fund I.

We are honored to welcome Korys as a sponsor and key advisor to the fund. Together with Mrieux Dveloppements sponsorship, privileged access to the experience and industrial network of Korys will bring real additional value to our portfolio of fast growing companies, said Valrie Calenda, Partner at Mrieux Equity Partners.

Our collaboration with Mrieux Equity Partners is based on an entrepreneurial history spanning several generations, common values and the shared ambition to dedicate significant, long-term resources within the healthcare and nutrition sectors. We look forward to a successful partnership, said Christoph Waer from Korys.

Thanks to significant support from Mrieux Dveloppement, Korys and the contribution of our business partners in North America, we are increasing our investment capacity in the life science sector, at a time when understanding and mastering biology is more important than ever, added Franois Valencony, President of Mrieux Equity Partners.

About Mrieux Equity Partners - http://www.merieux-partners.com

Mrieux Equity Partners is a management company registered with the Autorit des Marchs Financiers (AMF) since June 2018 that is dedicated to growth equity and venture capital investments. Mrieux Equity Partners currently operates with an international team of 20 employees and regional partners based in Europe and North America. With over EUR 650 million under management, Mrieux Equity Partners actively supports entrepreneurs and industrial companies whose products and services bring differentiated and innovative solutions in the healthcare and nutrition sectors by providing privileged access to its expertise and the industrial, scientific and commercial network of Institut Mrieux, in compliance with the current regulations.

About Korys - http://www.korys.be

Korys is the investment company of the Colruyt family. Today, it has more than EUR 4.5 billion of assets under management. Besides holding a significant participation in the Colruyt Group, a leading retail company in Belgium and France, it actively manages participations in privately held companies and in private equity funds. Korys has also set up proprietary funds to manage its portfolio of listed investments. Across its activities, Korys investment decisions are taken with a long-term perspective and on basis of strict economic (Profit), social (People) and ecological (Planet) criteria. Korys aims to create sustainable value in three major ecosystems: Life Sciences, Energy Transition and Conscious Consumer. To do this, Korys can count on a motivated team of 30 professionals based in Belgium and Luxembourg.

This press release is not a marketing communication in the European Union member states or non-member states. This press release is not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of securities made in the United States will be made by means of a prospectus that may be obtained from the issuer and will contain detailed information about the company and management, as well as financial statements.

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FDA Approves AstraZeneca’s Farxiga for Heart Failure in Adults with Reduced Ejection Fraction – BioSpace

By daniellenierenberg

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The U.S. Food and Drug Administration (FDA) announced on Tuesday that it has approved dapagliflozin, also known under the brand name Farxiga, for the treatment of heart failure in adults with reduced ejection fraction. The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.

AstraZenecas Farxiga is now the first in its drug class of sodium-glucose co-transporter 2 (SGLT2) inhibitors to be approved to treat adults with the New York Heart Associations functional class II-IV heart failure with reduced ejection fraction. AstraZeneca was granted with the approval of Farxiga related to heart failure by the FDA.

In a clinical trial, Farxiga appeared to improve survival and reduce the need for hospitalization in adults with heart failure and reduced ejection fraction.

To determine the efficacy of the drug, researchers looked at the number of instances of cardiovascular death, hospitalization for heart failure and urgent heart failure visits. Some trial participants were given a once-daily dose of 10mg of Farxiga, while others were given a placebo. After approximately 18 months, those who were given Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits compared to their counterparts.

Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans, said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDAs Center for Drug Evaluation and Research. This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.

Farxiga can cause side effects including dehydration, urinary tract infections and genetical yeast infections. It can also potentially result in serious cases of necrotizing fasciitis of the perineum in people with diabetes and low blood sugar when combined with insulin.

On Tuesday, BioCardia, Inc. also announced positive preclinical data supporting its new drug application for anti-inflammatory cell therapy for heart failure. BioCardias allogenic neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) therapy appeared to improve heart function in a study. NK1R+ MSC is being marketed under the name CardiALLO.

Researchers looked at 26 animals treated with both low dose and high dose CardiALLO in their study. Echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow all notably improved in the animals.

In light of these positive data on our allogenic NK1R+ MSC therapy, we expect to meet our internal timeline to complete our submission to the FDA for our first indication for CardiALLO, and potentially receive IND acceptance by the end of the second quarter, said BioCardia Chief Scientific Officer Ian McNiece, PhD. The MSCs that were studied are subtypes of MSC that we have delivered previously in our co-sponsored trials, which we believe have enhanced potency over MSC generated from unselected bone marrow cells. We look forward to seeing additional data from this animal study that are currently being analyzed, including histology and pathology of the heart and lungs.

BioCardia also intends to submit an IND for the use of NK1R+ MSC delivered via intravenous infusion for the treatment of Acute Respiratory Distress Syndrome caused by COVID-19.

Approximately 6.5 million adults in the U.S. are living with heart failure, according to the Centers for Disease Control and Protection. In 2017, it was a contributing cause of death in one out of eight people.

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Merck to Present New Data from its Broad Oncology Portfolio and Pipeline at the ASCO20 Virtual Scientific Program – Business Wire

By daniellenierenberg

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its oncology program will be presented at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program from May 29-31. More than 80 abstracts in nearly 20 types of solid tumors and blood cancers have been accepted across Mercks broad cancer portfolio and investigational pipeline, including KEYTRUDA, Mercks anti-PD-1 therapy; LENVIMA (in collaboration with Eisai); LYNPARZA (in collaboration with AstraZeneca); and MK-6482 (formerly PT2977), an investigational, oral hypoxia-inducible factor-2 alpha (HIF-2) inhibitor.

Despite the challenges we all face due to the COVID-19 pandemic, Merck remains fully committed to supporting the cancer community and to advancing important scientific research from our clinical program, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. The data to be presented at this years ASCO demonstrate how our deep and diverse oncology portfolio continues to show meaningful outcomes for patients in new tumor types and stages of disease, while long-term survival data for KEYTRUDA in non-small cell lung cancer, renal cell carcinoma and melanoma further support its important role in these types of cancer.

Key abstracts including late-breakers, oral sessions, and select poster discussions and posters to be presented at ASCO include:

Merck Investor Event

Merck will hold a virtual investor event in conjunction with the ASCO20 Virtual Scientific Program on Tuesday, June 2 at 2 p.m. ET. Details will be provided at a date closer to the event at http://investors.merck.com/home/default.aspx.

Details on Abstracts Listed Above, Additional Presentations and Key Abstracts with Mercks Collaboration Partners

KEYTRUDA

Breast Cancer

Bladder Cancer

Classical Hodgkin Lymphoma

Colorectal Cancer

Lung Cancer

Renal Cell Carcinoma

Prostate Cancer

Melanoma

Ovarian Cancer

Head and Neck Cancer

KEYTRUDA plus LENVIMA (in collaboration with Eisai)

Hepatocellular Carcinoma

Renal Cell Carcinoma

Endometrial Cancer

LYNPARZA (in collaboration with AstraZeneca)

Ovarian Cancer

MK-6482

Renal Cell Carcinoma

About KEYTRUDA (pembrolizumab) Injection, 100 mg

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

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

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

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

Head and Neck Squamous Cell Cancer

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

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

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

Classical Hodgkin Lymphoma

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

Primary Mediastinal Large B-Cell Lymphoma

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

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High (MSI-H) Cancer

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

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

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).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. 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 trial.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

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

Other Immune-Mediated Adverse Reactions

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

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

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

Infusion-Related Reactions

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

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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

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

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

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