Global Stem Cell Partnering Terms and Agreements 2021 Report – Featuring Regenetech, Stempeutics and Arthrex Among Others – ResearchAndMarkets.com -…

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Global Stem Cell Partnering Terms and Agreements 2021 Report - Featuring Regenetech, Stempeutics and Arthrex Among Others - ResearchAndMarkets.com -...

Lab-grown embryos prompt a question: Are they getting too real? – STAT – STAT

The stem cells were no more than a week old when scientists moved them from their slick-walled plastic wells into ones lined with a thin layer of human endometrial tissue. But in that time, the cells had multiplied and transformed, organizing themselves into semi-hollow spheres. Per the instructions of the chemical cocktail in which theyd been steeping, they were trying to turn into embryos.

Video cameras captured what happened next: The balls of cells rotated until they were cavity-side-up, before finally touching down and grabbing onto the endometrial layer, a cellular proxy for a human uterus. Days later, when the scientists dipped paper test strips into the wells, pink lines appeared. Their Petri dishes were pregnant.

These experiments clearly point out the fact that we are able to model in the dish the first touch between the embryo and the mother, stem cell biologist Nicolas Rivron told reporters at a press conference.

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On Thursday, Rivron and his colleagues at the Institute of Molecular Biotechnology of the Austrian Academy of Sciences in Vienna reported in Nature that theyve learned to efficiently manufacture realistic models of human embryos from stem cells. These so-called blastoids arent the first successful attempt to recapitulate the developmental stage that embryos reach between four and seven days post-fertilization when theyre a blastocyst made up of about a hundred cells and ready to implant into the walls of the uterus but they appear to be the most advanced yet.

These synthetic embryos were made by mixing induced pluripotent stem cells with a brew of biochemical signals capable of coaxing them into forming spherical structures that include the beginnings of three distinct cell lineages outer layers representing the future placenta and amniotic sac, and an inner clump of cells with the potential to develop into a fetus.

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This is a very, very close model of a real, complete human embryo, said Insoo Hyun, director of research ethics at the Harvard Medical School Center for Bioethics, who was not involved in the study. Its probably the closest Ive seen.

The field of synthetic embryology has exploded in recent years. A parade of increasingly lifelike models that mimic portions of an embryos journey to personhood promise to shed light on critical moments of human development while providing a more flexible and ethical alternative to the study of human embryos, which has been historically limited by regulations and the willingness of IVF donors.

As the science of synthetic embryology gets more sophisticated, the models become more useful. But each advance raises a new round of ethical questions about where embryo models end and embryos begin. If it divides, organizes, and develops like an embryo, does it matter how it was made? Should an embryo derived from stem cells get the same legal and ethical rights as one produced when sperm met egg?

At some point we have to ask, when does an embryo model become so good that it functionally becomes an embryo? said Hyun. And for me, that question starts to get raised here. Its not that the latest work on blastoids was unethical, he clarified. On the contrary, it met all the guidelines issued by the International Society for Stem Cell Research (ISSCR), which Hyun helped write. The latest version, issued in May, prohibits scientists from transferring blastoids, which contain all the cell types necessary for development, into a human or animal uterus. It was a really well-done paper, I thought it was kind of stunning actually, said Hyun. It just opens up these other questions.

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Already this year, five other groups around the world have independently reported methods for making blastoids, with varying degrees of efficiency and complexity. Two teams one at Monash University in Australia, one from the University of Texas Southwestern Medical Center in Dallas and Kunming Medical University in China published their results in Nature in March. Both teams also showed that their artificial structures formed similarly to real blastocysts. But both reported that only about 10% of the reprogrammed cells made the transition, and some of the structures contained cells not typically found in human blastocysts. Two other teams, one based in China and one based in the U.S. and the U.K., showed similar results while working with extended pluripotent stem cells. Another group, from the U.K., reported in Cell Stem Cell in June achieving much higher efficiencies between 30% and 80% of their stem cells expanded into blastoids. The Austrian groups blastoids were even more efficient, forming more than 70% of the time.

Its been a big year for blastoids, said Jianping Fu, a bioengineer at the University of Michigan whose lab created some of the earliest human embryo models from stem cells in 2017.

In 2018, Fu and Rivron joined Hyun and several others in writing an editorial urging lawmakers to ban the use of stem-cell based synthetic embryos for reproductive purposes while preserving their use for some types of research. They encouraged regulators to treat embryo models in the same way many nations dealt with cloning in the late 1990s and early 2000s. We think that the intention of the research should be considered the key ethical criterion by regulators, rather than surrogate measures of the equivalence between the human embryo and a model, they wrote.

Hyun said he still stands by those recommendations, to a point, even if it makes the slippery-slope crowd nervous. The further along you get in modeling pregnancy, the harder it is to justify those experiments on the grounds that theres no other way to answer your research question, said Hyun. Scientists have been able to glean insights into the earliest stages of development by studying human embryos donated by families whove undergone IVF. Tissue from aborted fetuses has provided clues about later stages of pregnancy. But from the time an embryo implants until the time a person realizes theyre pregnant, scientists have virtually no way of knowing whats going on.

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Its a total black box, said Hyun. But it maxes out at about 28 days. And what most people dont realize is that means theres a natural limitation on how long you could justify an experiment with synthetic embryos. Once you traverse the black box of development, theres no need to keep going in the dish.

Although its not required by law or the latest ISSCR guidelines, which relaxed the long-held 14-day rule barring research on embryos older than two weeks, the Austrian researchers did not allow their artificial embryos to develop past 13 days. But Rivron said he does not expect any of the blastoids to have the ability to develop into a complete embryo, even if allowed the chance.

A few years ago, his team successfully grew blastocysts in the lab from mouse stem cells. Ever since, theyve been implanting the blastoids into the uteruses of living mice and crossing their fingers. But theyve never successfully made any mice pups. Rivron said hed expect the same thing for their human blastoids if they were implanted into a functioning uterus (an experiment the ISSCRs guidelines, as well as laws in a handful of countries, expressly forbid). After implantation on the uterus-in-a-dish, the blastoids didnt grow or organize as well as what youd expect from real embryos in a real womb, said Rivron. These are very nice models, but we are far from any potential of using them for reproduction.

So how does he expect scientists might use them instead? A logical application would be to use them for drug discovery and screening a process that would require large numbers of these embry(ish)os. Now that we have formed a reliable embryo model, we can uniquely understand the molecules at play, and I believe that these molecules will actually become tomorrows medicines to enhance fertility or to be used as contraceptives, said Rivron. His group is already working with collaborators to test an FDA-approved drug that prevented the innermost cells of the blastoid from forming. Because those cells instruct the outer cells to become sticky, disrupting them could offer a hormone-free way to prevent embryos from implanting.

Other as-yet-discovered drugs could possibly enhance the implantation process, thereby improving the odds of getting pregnant. Compared to creating a fully competent synthetic embryo, using existing models to find and develop drugs is achievable on a relatively short timescale, said Rivron. This is not something that requires 10 years.

Other scientists have other ideas. Fu said an obvious immediate application would be to use large numbers of blastoids to systematically figure out better recipes for the medium that IVF clinics use to culture embryos prior to implantation. There are a lot of unknowns in how culture medium conditions affect the growth and development of human embryos, including successful implantation, said Fu. Those are questions that can better be answered now.

To Martin Pera, a stem cell researcher at the Jackson Laboratory, an even more powerful application would be to use these models to better understand how organisms precisely alter the expression of genes in different types of cells during early development. Its a very dynamic time, epigenetically, said Pera.

Since the 1990s, some scientists have argued for the fetal origins of adult disease; that the intrauterine environment, especially during times of bodily stress, may predispose a developing fetus to worse health outcomes later in life. We need models to replicate that, and this is an important start, Pera said.

Science Writer

Megan Molteni is a science writer for STAT, covering genomic medicine, neuroscience, and reproductive tech.

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Lab-grown embryos prompt a question: Are they getting too real? - STAT - STAT

Acrivon Therapeutics Announces its Scientific Advisory Board with Renowned Oncology Thought Leaders – The Bakersfield Californian

WATERTOWN, Mass., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary, proteomics-based technologies driving a new era of precision-based medicine, today announced the establishment of its scientific advisory board.

We are delighted to have these distinguished thought leaders in oncology research and development join our scientific advisory board, said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and founder of Acrivon. Combined, they represent expertise across Acrivons key pillars of excellence including phospho-proteomics, predictive protein biomarkers, and oncology precision medicine. The caliber of this group, in addition to the high-quality investors who participated in our recent oversubscribed $100 million Series B financing, is a testament to the promise of our unique precision medicine platform.

George Demetri, M.D., professor at Harvard Medical School, co-director of the Ludwig Center, and senior vice president at the Dana-Farber Cancer Institute, added, I am very enthusiastic to help advance the potential benefit to patients from Acrivons pioneering proteomics-based precision medicine platform. The future of precision medicine lies in the ability to identify the right patients with complex cancers who can derive the maximal benefit from specific targeted therapies and rational combinations. Acrivons platform enables a unique approach to patient selection with the promise to be broadly applicable beyond the limitations of current tumor genome tests. We hope this will allow identification of direct mechanistic matching between the drug action with the primary drivers of malignancyin an individual patients tumor to predict treatment benefit with far less empiricism than current standards of care.

Scientific Advisory Board Members George Demetri, M.D., F.A.C.P., F.A.S.C.O., F.A.A.C.R. Dr. Demetri is co-director of the Ludwig Center at Harvard and professor of Medicine at Harvard Medical School and serves as senior vice president for experimental therapeutics at the Dana-Farber Cancer Institute (DFCI). Dr. Demetri was instrumental in the development of Gleevec (imatinib) as the first effective therapy for gastrointestinal stromal tumor (GIST) as a mutationally-driven solid tumor. His collaborative research efforts have contributed to worldwide regulatory approval of several other therapies, including sunitinib and regorafenib for GIST, as well as pazopanib, trabectedin, eribulin, and tazemetostat for other sarcomas. He is a member of the board of directors for Blueprint Medicines.

Dr. Demetri received his A.B. in Biochemistry at Harvard College and M.D. from Stanford Medical School. He completed his residency and chief residency at the University of Washington Hospitals in Seattle and his medical oncology fellowship at DFCI and Harvard Medical School. Dr. Demetri was the 2020 recipient of the David A. Karnofsky Memorial Award from the American Society of Clinical Oncology (ASCO).

Robert (Bob) Abraham, Ph.D. Dr. Abraham is executive vice president and head of cancer biology at Odyssey Therapeutics. Before that, he was most recently chief scientific officer at Vividion Therapeutics. Prior to Vividion, he was the senior vice president and world-wide head of the oncology R&D group at Pfizer. From 2005-2009, he was the head of oncology discovery research at Wyeth. During his tenure at Wyeth and Pfizer, Dr. Abraham contributed to the development of eight FDA-approved cancer drugs. Prior to joining industry, Dr. Abraham was a professor at the Sanford-Burnham-Prebys Medical Discovery Institute (SBPMDI) in La Jolla, CA, where he served as the director of the NCI-designated SBPMDI Cancer Research Center. Prior to SBPDMI, he was endowed chair in the Department of Pharmacology and Cancer Biology at the Duke University Medical Center. Prior to Duke University, Dr. Abraham held dual professorships in the departments of Immunology and Pharmacology at the Mayo Clinic in Rochester, MN. He maintains adjunct professor appointments at U.C. San Diego (Department of Pharmacology), and at the Sanford Burnham Prebys Institute.

Dr. Abraham began his career as an academic investigator, with enduring interests in cancer biology and immunology. His major research interests included characterization and functional analysis of the mammalian Target of Rapamycin (mTOR) signaling pathway, cancer metabolism, cellular signaling and DNA damage responses. Dr. Abraham has authored over 225 scientific publications, and his published work has been cited over 48,000 times. Dr. Abraham received his B.S. in Biology from Bucknell University and his Ph.D. in Pharmacology at the University of Pittsburgh, and he completed his postdoctoral training in Pharmacology and Immunology at the Mayo Clinic.

Timothy A. Yap, M.B.B.S., Ph.D., F.R.C.P. Dr. Yap is an associate professor in the departments for Investigational Cancer Therapeutics and Thoracic/Head and Neck Medical Oncology at the MD Anderson Cancer Center. He is also the medical director of the Institute for Applied Cancer Science, a drug discovery biopharmaceutical unit where drug discovery and clinical translation are seamlessly integrated. He is also an associate director of translational research at the Institute for Personalized Cancer Therapy, an integrated research and clinical trials program. Previously, Dr. Yap was a consultant medical oncologist at The Royal Marsden Hospital in London, UK and National Institute for Health Research BRC clinician scientist at The Institute of Cancer Research, London, UK.

Dr. Yaps primary research focuses on development of targeted agents and their acceleration through biomarker-driven clinical trials. His main interests include targeting of the DNA damage response as well as the development of novel immunotherapeutics, and past and currenthe is and/or has been a principal investigator for multiple clinical trials evaluating novel strategies for targeting the DNA damage response in cancer. Dr. Yap obtained his B.Sc. degree in Immunology and Infectious Diseases at Imperial College London, UK, and subsequently went on to attain his medical degree from Imperial College London, UK. He has a Ph.D. in Molecular Pharmacology from the Division of Cancer Therapeutics at the Institute of Cancer Research, London, UK.

David Berman, M.D., Ph.D. Dr. Berman is a professor and chair of the department of Pathology and Molecular Medicine at Queen's University in Kingston, Ontario. He is board certified in Anatomic Pathology and practices urologic surgical pathology at Kingston Health Sciences Centre while also running a biomarker discovery laboratory focused on urologic cancers. Dr. Berman earned his M.D. and Ph.D. (Genetics and Development) degrees from the University of Texas, Southwestern Medical Center. He completed residency training and a postdoctoral research fellowship at Johns Hopkins where he established his independent research laboratory, which moved to Canada in 2012. The Berman laboratory focuses on basic, translational, and clinical aspects of prostate and bladder cancer. His research has helped identify bladder cancer stem cells and druggable targets in embryonic signaling pathways, and it has helped improve surgical pathology practice.

Dr. Berman was director of the Queens Cancer Research Institute from 2015-2021 and has served on research advisory committees for the Canadian Cancer Society (ACOR), the Canadian Cancer Trials Group, and Bladder Cancer Canada. He currently leads a translational research effort for the Canadian Bladder Cancer Research Network.

Jesper Olsen, Ph.D. Dr. Olsen is an academic co-founder and head of phosphoproteomics at Acrivon Therapeutics, Inc. He is a professor in quantitative proteomics at the University of Copenhagen and vice director of the Novo Nordisk Foundation Center for Protein Research. Dr. Olsen is a pioneer in mass spectrometry based phosphoproteomics and its applications to decipher cell-signaling networks at a systems-wide scale, and his research interest is developing and applying phosphoproteomics technologies for comprehensive kinase drug profilings with clinical actionability. Dr. Olsen is the most cited phosphoproteomics expert world-wide and among top 0.1% in protein sciences.

Dr. Olsen received his M.Sc. in Analytical Chemistry at the University of Southern Denmark and his Ph.D. in Biochemistry and Molecular Biology at the same place under the supervision of Prof. Matthias Mann. Dr. Olsen completed his post-doctoral training in proteomics and cell signaling at the Max Planck Institute for Biochemistry in Munich. He is based in Copenhagen since 2009, where he joined the newly established Center for Protein Research, initially as group leader and since 2014 as vice director.

About Acrivon Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature companion diagnostics that can be used to identify patients most likely to benefit from Acrivons medicines. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The companys pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Lilly which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the companys website at https://acrivon.com for more information.

Acrivon Contacts: Alexandra Santos asantos@wheelhouselsa.com

Aljanae Reynolds areynolds@wheelhouselsa.com

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Acrivon Therapeutics Announces its Scientific Advisory Board with Renowned Oncology Thought Leaders - The Bakersfield Californian

Be The Match BioTherapies and Vineti collaborate to develop innovative, integrated supply chain management solutions for cell and gene therapies -…

MINNEAPOLIS and SAN FRANCISCO, Dec. 08, 2021 (GLOBE NEWSWIRE) -- Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies (CGTs), and Vineti, the provider of the leading digital enterprise platform for cell and gene therapy supply chains, today announced a collaboration to develop joint solutions that simplify and scale supply chain management of cell and gene therapies.

The non-exclusive collaboration will bring together industry leaders in workflow and logistics solutions -- Be The Match BioTherapies cellular therapy supply chain management services and Vinetis Personalized Therapy Management (PTM) platform. The collaboration will enable the Be The Match BioTherapies Cell Therapy Supply Chain Managers and Logistics Coordinators to utilize the PTM platform on behalf of shared biopharmaceutical clients with greater efficiency and simplicity.

The organizations leverage complementary strengths in starting material collection, cell therapy supply chain and managed logistics, Chain of Identity (COI) and Chain of Custody (COC), and enterprise-grade digital solutions for end-to-end value chain management. The collaboration will provide unique integrated solutions for these mission-critical components of CGT operations, and will simplify workflows, speed time to treatment, and provide the flexibility that CGT development requires.

This is a message to the industry that both parties are committed to improving our clients experience, and to improving outcomes for patients by building a combined solution that eliminates unnecessary complexity, said Amy Ronneberg, CEO of the National Marrow Donor Program (NMDP)/Be The Match and Be The Match BioTherapies.

By combining each teams core expertise, the organizations aim to create innovative solutions that blend Be The Match BioTherapies best in class cell therapy supply chain services with Vinetis proven expertise in advanced therapy management and enterprise grade digital technology to deliver next-generation therapy management, automated traceability, and digitized compliance for CGTs.

Were very honored to partner with Be The Match BioTherapies, said Amy DuRoss, CEO and Co-founder of Vineti. Both organizations share a focus on driving transformative outcomes for patients that wouldnt be possible without cell and gene therapies. Well be able to offer a solution that reduces timelines to the clinic, while allowing CGT developers to simplify and scale operations with best-in-case expertise, services, and digital tools.

The Be The Match BioTherapies-Vineti solution will be available from both organizations Business Development teams. This news follows the recent Be The Match BioTherapies webinar on scalable and efficient cell collection networks as well as Vinetis recent partnership announcement with Autolomous.

About Be The Match BioTherapies

Be The Match BioTherapiesis the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of theNational Marrow Donor Program/Be The Match, and a research partnership with theCIBMTR(Center for International Blood and Marrow Transplant Research), the organization designs solutions that advance the development of cell and gene therapies across the globe.

Be The Match BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from theBe The Match Registry, the worlds most diverse registry of more than 22 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection, and transplant centers worldwide, the organization develops, onboards, trains, and manages expansive collection networks to advance cell therapies. Be The Match BioTherapies uses a proven infrastructure consisting of regulatory compliance and managed logistics experts and cell therapy supply chain case managers to transport and deliver regulatory-compliant life-saving therapies across the globe successfully. Through the CIBMTR, Be The Match BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.

For more information, visitwww.BeTheMatchBioTherapies.comor follow Be The Match BioTherapies onLinkedInor Twitter.

About Vineti

Vineti offers the first commercial, configurable cloud-based platform to expand patient access to life-saving cell and gene therapies. Vineti was co-founded by GE and the Mayo Clinic to solve the key challenges that patients, medical providers, biopharmaceutical companies, and regulators face in the delivery and commercialization of individualized therapies. Now a fully independent company, Vineti offers a digital platform of record to integrate logistics, supply chain management, manufacturing, and clinical data for personalized therapies. The Vineti Personalized Therapy Management(PTM) platform aligns and orchestrates the advanced therapy process and improves product performance overall, supporting the full continuum of patient-specific therapies, including personalized cancer vaccines and autologous and allogeneic cell and gene therapies. Vineti is currently serving patients, healthcare providers, and researchers in hundreds of leading medical centers and manufacturing centers world-wide on behalf of a growing number of biopharmaceutical partners. The World Economic Forum has honored Vineti as a World Economic Forum Technology Pioneer. Vineti is headquartered in San Francisco, California, with teams based in the Washington, D.C. area and Yerevan, Armenia. For more information, please visithttp://vineti.com.

Contact Information:

Bonnie Quintanilla, Clarity Quest (for Be The Match BioTherapies) bonnie@clarityqst.com

Dan Budwick, 1AB Media (for Vineti) dan@1abmedia.com

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Be The Match BioTherapies and Vineti collaborate to develop innovative, integrated supply chain management solutions for cell and gene therapies -...

Surgical Sutures Market to Grow by 5.6% as Application Increases in Knotless and Electronic Products Manufacturing – BioSpace

Surgical Sutures Market Value to Reach US$ 6.5 Bn as Governments Eliminate Trade Duties on Medical Devices

Fact.MR combines trend analysis and quantitative forecasting to provide readers with the latest insight of the surgical sutures market. The study contains distinctive information through exhaustive primary and secondary research methodologies. It also includes detailed information about various segments in terms of product type, raw material, source, application, and end-user across seven major regions.

Fact.MR A Market Research and Competitive Intelligence Provider: The global surgical sutures market is expected to reach US$ 6.5 Bn, exhibiting growth at a CAGR of 5.6% during 2021 to 2031, estimates Fact.MR. Rising number of trauma patients are expected to drive the growth in the surgical sutures market.

Surgical sutures have gained immense popularity across the globe owing to ongoing technological advancement in this field. Governments of various countries are also supporting the usage of these products for improving their healthcare facilities.

Additionally, compared to the conventional non-absorbable sutures, the new absorbable ones are the most preferred sutures among surgeons across the globe due to their high Average Selling Price (ASP).

Further, several manufacturers are investing extensively to develop novel electronic, bioactive, antimicrobial, and knotless surgical sutures for the healthcare sector. These new sutures are beneficial in detecting infections or leakages in the wound.

Also, to enable efficient drug delivery to the surgical site, some of the key players have come up with stem cell-seeded and drug-eluting sutures. These factors are anticipated to bolster the surgical sutures market growth in the forecast period.

With governments eliminating restrictions, trade duties, and customs on medical devices by launching new agreements, sales of surgical sutures are expected to witness an uptick through 2021. The Trans-Pacific Partnership (TPP) and the North American Free Trade Agreement (NAFTA) are the two significant examples of such agreements. This has helped the market to generate nearly US$ 20.5 trillion of revenue and the trend is likely to continue over the coming years, declares a Fact.MR analyst.

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Competitive Landscape

Presence of numerous leading players in the surgical suture market has led to severe competition in the market. Some of these companies are adopting strategies, such as mergers & acquisitions, partnerships, and new product development to gain competitive edge.

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Fact.MR provides an unbiased analysis of the surgical sutures market, presenting historical demand data (2016-2020) and forecast statistics for the period from 2021-2031. The study divulges compelling insights on the global surgical sutures market with a detailed segmentation on the basis of:

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Absorbable Surgical Sutures Market Report: Absorbable Surgical Sutures market analysis is done on the basis of product (Polyglycolic Acid sutures, Polyglactin 910, Catgut absorbable sutures, Poliglecaprone 25, Polydioxanonen absorbable surgical sutures)

Polyglyconate Sutures Market Analysis: Polyglyconate Sutures Market Analysis on the basis of Applications (Cardiovascular Surgeries, General Surgeries, Gynecological Surgeries & Orthopedic Surgeries). Rising number of surgeries and augmenting demand for advanced treatment procedures propel the market of polyglyconate sutures market in North America.

Laparoscopic Sutures Market Research: Laparoscopic Sutures Market analysis on the basis of Product type (Stitch Suturing Devices & Laparoscopy Suturing Needles). Laparoscopic needles are expected to hold a large revenue share in the laparoscopic sutures market.

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Surgical Sutures Market to Grow by 5.6% as Application Increases in Knotless and Electronic Products Manufacturing - BioSpace

Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed…

TOKYO & MUNICH & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced positive topline results from the global pivotal QuANTUM-First phase 3 trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML).1

QuANTUM-First met its primary endpoint, demonstrating that patients who received quizartinib in combination with standard induction and consolidation chemotherapy and then continued with single agent quizartinib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to those who received standard treatment alone. The safety of quizartinib was shown to be manageable and consistent with the known safety profile.

AML is one of the most common forms of leukemia in adults, representing about one-third of all cases.2 The five-year survival rate of AML is about 29%, and patients with FLT3-ITD positive AML have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1,3 There remains a high unmet need to improve survival for the majority of patients with AML.4

The results of the phase 3 QuANTUM-First trial showed that adding quizartinib, a potent and selective FLT3 inhibitor, to chemotherapy significantly prolonged overall survival in patients with newly diagnosed FLT3-ITD positive AML, said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. We look forward to sharing the QuANTUM-First data with the hematology community and will initiate discussions with global regulatory authorities.

Data from QuANTUM-First will be presented at an upcoming medical meeting and shared with regulatory authorities globally.

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, multi-center global phase 3 study evaluating quizartinib in combination with standard induction and consolidation chemotherapy and then as continued single agent therapy in adult patients (age 18 75) with newly diagnosed FLT3-ITD positive AML.

Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo in combination with standard anthracycline and cytarabine-based induction and consolidation regimens. Eligible patients, including those who underwent allogenic hematopoietic stem cell transplant (HSCT), continued with single agent quizartinib or placebo for up to 36 cycles.

The primary study endpoint is OS. Secondary endpoints include event-free survival (EFS), post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, were also evaluated.

QuANTUM-First enrolled 539 patients at approximately 200 study sites worldwide including in Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About Acute Myeloid Leukemia (AML)

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.5 AML is one of the most common types of leukemia in adults, representing about one-third of all cases.2 A heterogenous blood cancer, AML is characterized by a five-year survival rate of about 29%, the lowest by far among the major leukemia subtypes.6,7

Treatment guidelines for patients with newly diagnosed AML recommend a cytarabine-based chemotherapy regimen with or without a targeted therapy as determined by the presence of genetic mutations, age and other factors.8 Patients with newly diagnosed FLT3 mutated AML may receive a FLT3 inhibitor as part of their initial treatment regimen and/or subsequent regimens.8 While intensive chemotherapy and/or HSCT can improve chances for sustained remission in eligible patients, a substantial proportion of patients are not suitable for either intervention, and cure rates are particularly low for older patients.1,6 In recent years, new targeted treatments have increased options and improved outcomes for some patients with molecularly defined AML subtypes.6

About FLT3-ITD

FLT3 (FMS-like tyrosine kinase 3) is a transmembrane receptor tyrosine kinase protein normally expressed by hematopoietic stem cells; FLT3 plays an important role in cell development by promoting cell survival, growth and differentiation through various signaling pathways.1 Mutations of the FLT3 gene, which occur in approximately 30% of patients with AML, can drive oncogenic signaling.1 The most common type of FLT3 mutation is the FLT3-ITD (internal tandem duplication), which is present in about 25% of all AML patients and contributes to cancer cell proliferation.1 Patients with FLT3-ITD mutations have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1

About Quizartinib

Quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, is in phase 1/2 clinical development in pediatric and young adult patients with relapsed/refractory FLT3-ITD AML in Europe and North America.1 Several phase 1/2 combination studies with quizartinib are also underway at The University of Texas MD Anderson Cancer Center as part of a strategic research collaboration focused on accelerating development of Daiichi Sankyo pipeline therapies for AML.

Quizartinib is currently approved for use in Japan under the brand name VANFLYTA for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan.

About Daiichi Sankyo Oncology

The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose to contribute to the enrichment of quality of life around the world. In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an Innovative Global Healthcare Company Contributing to the Sustainable Development of Society. For more information, please visit http://www.daiichisankyo.com.

References

1 Daver N et al. Leukemia. (2019) 33:299312. 2 American Cancer Society. Key Statistics for Acute Myeloid Leukemia. Updated January 2020. 3 Leukemia and Lymphoma Society. Facts and Statistics. Leukemia: Survival (SEER Data for 2009-2015). 4 Daver N et al. Blood Cancer Journal. (2020) 10:107. 5 Global Cancer Observatory. Population Fact Sheet: World. Updated November 2020. 6 Short et al. Cancer Discov. (2020);10:50625. 7 Leukemia and Lymphoma Society. Facts and Statistics. Leukemia: Survival (SEER Data for 2009-2015). 8 NCCN Practice Guidelines for Oncology. Acute Myeloid Leukemia. Version 3.2021 (March 2, 2021).

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Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed...

Researcher awarded $12 million for a stem cell trial to improve outcomes of young blood cancer patients – Stanford Medical Center Report

The California Institute for Regenerative Medicine has awarded nearly $12 million to support a clinical trial of a new cell-based treatment to improve outcomes and survival rates among children and young adults with blood cancer who receive a stem cell transplant.

The treatment, named T-allo10, aims to improve immune responses to pathogens and cancer without increasing the likelihood of graft-versus-host disease in patients who must receive a transplant from an imperfectly matched donor.

The trial will be led by Maria Grazia Roncarolo, MD, professor of pediatrics and of medicine. Roncarolo is the George D. Smith Professor of Stem Cell and Regenerative Medicine, director of the Stanford Center for Definitive and Curative Medicine and co-director of the Institute for Stem Cell Biology and Regenerative Medicine.

Every year around 500 children receive stem cell transplants in California, and while many children do well, too many experience a rejection of the transplant or a relapse of the cancer, Maria Millan, MD, president and CEO of the institute said in a press release. Finding an improved therapy for these children means a shorter stay in the hospital, less risk of the need for a second transplant, and a greater quality of life for the child and the whole family.

The current standard of care for many blood cancers is a two-part treatment of chemotherapy to destroy a patients cancer cells followed by a transplant of blood and immune stem cells from an immunologically matched donor. However, patients sometimes only have the option of receiving a transplant thats a partial immunological match, increasing the risk of graft-versus-host disease, in which the donor immune cells attack the recipients tissues. To reduce this risk, a subset of the donated cells is removed prior to transplant, which in turn increases the chance of a cancer relapse or dangerous infection.

Roncarolo and her team will test T-allo10, in which mature immune cells are concurrently administered with cells called type 1 regulatory T cells, or Tr1 cells, from the donor after a stem cell transplant. The Tr1 cells, which were originally discovered by Roncarolos team, reduce the likelihood that the donors immune cells will perceive the recipients tissue as foreign.

T-allo10 is intended to improve transplant outcomes by reducing cancer recurrence and infection rates, as well as the likelihood of graft-versus-host disease.

My team and I are thrilled to receive CIRMs support for our immunotherapy clinical trial, which may help patients with leukemia receiving a blood stem and progenitor cell transplant fromnonperfectly matched donors a population that continues to suffer poor outcomes and that has high unmet need, Roncarolo said. T-allo10 is unique, as it contains both Tr1 cells, which prevent graft-versus-host disease and rejection, and cells that can fight infections and eliminate residual cancer cells in a single cell product. The development from the bench to the bedside of a Tr1 cell-based product to improve the outcomes of stem cell transplant and induce tolerance is a shining example of the cutting-edge translational work conducted at the Stanford Center for Definitive and Curative Medicine.

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Researcher awarded $12 million for a stem cell trial to improve outcomes of young blood cancer patients - Stanford Medical Center Report

Vaccines less effective at protecting against severe COVID-19 in immunocompromised adults – EurekAlert

INDIANAPOLIS -- New real-world evidence gathered by the U.S. Centers for Disease Control and Prevention (CDC) shows that COVID-19 vaccines are less effective at protecting against COVID-19-associatedhospitalizations in people who are immunocompromised.

In general, immunocompromised individuals are at an increased risk for severe COVID-19 outcomes.

These findings indicate thatwhile two-doses of mRNA COVID-19 vaccines are beneficial inimmunocompromised individuals, theyaresignificantlyless protected from severe disease than people with normal immune systems, said study lead author PeterEmb, M.D., M.S., Regenstrief Institute president and chief executive officer andassociate dean for informatics and health services research at theIndiana UniversitySchool of Medicine. Since they are less protected after a two-dose series, those who are immunocompromisedshould receive an additional dose and a booster, take additional precautions like masking when in public, and, if they get infected, they should seek treatment with proven therapies that can protect against progression to severe disease and the need for hospitalization.

The research team gathered data from more than 89,000 hospitalizations across nine states, making this the largest study of its kind evaluating COVID-19 vaccine effectiveness among immunocompromised people. Data analyses showed that mRNA vaccines (manufactured by Pfizer andModerna) were 90 percent effective at protecting against COVID-related hospitalization in immunocompetent individuals, whereasthey wereonly 77 percent effective in those with suppressed immunity due to a range of health conditions. The differences were similar across age groups. However, the effectiveness varied greatly amongimmunocompromisedsubgroups. For example, it was lower in organ or stem cell transplant patients and better in people with rheumatologic or inflammatory disorders.

Thedata camefrom theVISION Network,a collaboration between the CDC andseven organizationswith integrated medical, laboratory and vaccination records. The network was established to assessthe effectiveness of COVID-19 vaccines.In addition to Regenstrief Institute, other members are Columbia University Irving Medical Center, HealthPartners, Intermountain Healthcare, Kaiser Permanente Northern California, Kaiser Permanente Northwest and University of Colorado.

The paper,Effectiveness of Two-Dose Vaccination with mRNA COVID-19 Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults nine states, JanuarySeptember 2021, is published in the CDCs Morbidity and Mortality Weekly Report.

Dr.Embis the first author. Other authors from Regenstrief and IU are Shaun Grannis, M.D., M.S.; Brian Dixon, PhD, MPA; William F. Fadel, PhD andNimish R.Valvi, DrPH.

Other authors on the paper areMatthew E. Levy, PhD, ofWestat; Allison L.Naleway, PhD, of Kaiser Permanente Northwest; Palak Patel, MBBS, of the CDC COVID-19 Response Team;ManjushaGaglani, MBBS, of Texas A&M University; Karthik Natarajan, PhD, of Columbia University and New York Presbyterian Hospital; KristinDascomb, M.D., PhD, of Intermountain Healthcare;ToanC. Ong, PhD, of University of Colorado; Nicola P. Klein, M.D., PhD, of Kaiser Permanente Northern California; I-Chia Liao,MPH, of Texas A&M University;JungmiHanof Columbia University; EdwardStenehjem, M.D., of Intermountain Healthcare; Margaret M. Dunne, MSc, ofWestat; Ned Lewis, MPH, of Kaiser Permanente Northern California;Stephanie A. Irving, MHS, ofKaiser Permanente Northwest; Suchitra Rao, MBBS, of University of Colorado; Charlene McEvoy, M.D., of HealthPartners Institute; Catherine H.Bozio, PhD, of the CDC COVID-19 Response Team;KempapuraMurthy, MBBS, of Texas A&M University; Nancy Grisel, MPP, of Intermountain Healthcare; Duck-HyeYang, PhD, ofWestat; Kristin Goddard, MPH, of Kaiser Permanente Northern California; Anupam B. Kharbanda, M.D., of Childrens Minnesota; Sue Reynolds, PhD, of the CDC COVID-19 Response Team; ChandniRaiyani, MPH, of Intermountain Healthcare; JulieArndorfer, MPH, of Intermountain Healthcare; Elizabeth A. Rowley, DrPH, ofWestate; Bruce Fireman, M.A., of Kaiser Permanente Northern California; JillFerdinands, PhD, of the CDC COVID-19 Response Team; Sarah W. Ball, ScD, ofWestat;OussenyZerbo, PhD. Of Kaiser Permanente Northern California; Eric P. Griggs, MPH, of the CDC COVID-19 Response Team; Patrick K. Mitchell, ScD, ofWestate; Rachael M. Porter, MPH, of the CDC COVID-19 Response Team; Salome A.Kiduko, MPH, ofWestat;LeneeBlanton, MPH, of the CDC COVID-19 Response Team; Yan Zhuang, PhDofWestat; Andrea Steffens, MPH, of the CDC COVID-19 Response Team; Sarah E. Reese, PhD, ofWestat; Natalie Olson, MPH, of the CDC COVID-19 Response Team; Jeremiah Williams, MPH, of the CDC COVID-19 Response Team; Monica Dickerson, MPH,of the CDC COVID-19 Response Team; Meredith McMorrow, M.D.of the CDC COVID-19 Response Team; Stephanie J.Schrag, DPhil,of the CDC COVID-19 Response Team; Jennifer R.Verani, M.D.of the CDC COVID-19 Response Team; Alicia M. Fry, M.D.of the CDC COVID-19 Response Team; EduardoAzziz-Baumgartner, M.D.of the CDC COVID-19 Response Team; Michelle A. Barron, M.D., of the University of Colorado; Mark G. Thompson, PhD,of the CDC COVID-19 Response TeamandMalini B. DeSilva, M.D. of HealthPartners Institute.

About Regenstrief Institute

Founded in 1969 in Indianapolis, theRegenstrief Instituteis a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.

Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institutes research mission.

About IU School of Medicine

IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.

AboutPeterEmb, M.D., M.S.

In addition to serving as the president and CEO of Regenstrief Institute, PeterEmb, M.D., M.S. is the LeonardBetleyProfessor of Medicine and associate dean for informatics and health services research at Indiana University School of Medicine, associate director of informatics with Indiana Clinical andTranslational Sciences Institute and vice president for Learning Health Systems with Indiana University Health.

Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines Against COVID-19Associated Hospitalizations Among Immunocompromised Adults Nine States, JanuarySeptember 2021

2-Nov-2021

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Vaccines less effective at protecting against severe COVID-19 in immunocompromised adults - EurekAlert

Heart Tissue in a Dish Reveals New Links Between Neurodegeneration and Heart Disease – PRNewswire

Some cases of heart failure have root causes surprisingly similar to diseases like Alzheimers, Huntingtons and ALS.

Over time, sometimes quite rapidly, the heart's thick strong muscle tissue becomes thin and weak, causing the left ventricle to swell like a balloon. This makes the heart less able to squeeze efficiently, which can lead to blood clots, irregular heartbeats, and sometimes sudden death when the malfunctioning heart simply stops beating. The origins of cardiomyopathy are diverse, including viral infections, autoimmune diseases, toxic drug exposures, and dozens of gene mutations.

Now, a multi-disciplinary team of clinicians and researchers has deciphered the function of a specific genetic mutation that causes cardiomyopathy. Their findings,published Nov. 3, 2021, in Nature Communications, were made possible by growing gene-edited human heart tissue from induced pluripotent stem cells and measuring the activity, location and binding of this mutant protein.

The team was led by co-corresponding authors Charles Murry, MD, PhD, a regenerative medicine expert at the University of Washington; Bruce Conklin, MD, a genetic engineering expert with the Gladstone Institutes in California, and Nathan Salomonis, PhD, a computational genomics expert at Cincinnati Children's.

"We hope this study will lead to broader insights that could lead to improved heart failure therapies," Conklin says.

Cutting-edge experiments expose more of the heart's inner workings

Over the last several decades, the research community has made many discoveries that have led to improved medications and medical devices that can dramatically extend life by slowing down the progression of heart failure. However, we still lack proven cures.

This study reveals a new mechanism of cardiomyopathy initiation by the RNA binding motif protein 20 (RBM20). This protein helps control RNA splicing in the heart, the process by which RNAs are sliced and diced to give rise to different proteins in different tissues. Normally, RBM20 splices RNAs to make proteins that enable the heart to adapt to stress and contract regularly throughout a person's entire life. But a class of mutations in RBM20 result in severe cardiomyopathy in adulthood.

"We and others had previously studied RBM20's function during heart development, but we had little to no clue of why it stops working in disease. We needed to step up our game if our research was to have a clinical impact," says Alessandro Bertero, PhD, who contributed to the work while at the University of Washington and now leads an Armenise-Harvard Laboratory at the University of Turin in Italy.

Discovering this protein's role was especially complex because knocking out this gene in animal models does not mimic the damaging effects seen in people. Instead, the work required editing the genome of healthy cells and engineering human heart tissue from these cells in a lab dish. Only by producing heart tissue similar to that found in humans could the authors understand the contractile defects and molecular mechanisms underlying this gene's function in a controlled manner.

"That was exactly what we intended when we started this project by genome-editing induced pluripotent stem cells," says co-leading author Yuichiro Miyaoka, PhD, of the Tokyo Metropolitan Institute of Medical Science.

First, the team observed that the engineered muscle tissue carrying the mutant form of RBM20 did not function like tissue engineered with normal RBM20 or lacking the protein all together. The mutated muscle fibers contracted with significantly less force and upstroke velocity, much like a heart affected by cardiomyopathy.

Then, at the single-cell level, the team detected another important clue. Normally, RBM20 is located exclusively within the cell nucleus. However, the mutated form localizes almost entirely out of the nucleus, in the cell's cytoplasm.

This, by itself, did not mean muchuntil the cell was exposed to heavy stress. When that occurred, the mutant protein was detected within tiny "stress granules" made of protein and RNA that cells rapidly produce as a reaction to stress. In contrast, RBM20 in healthy cells remained within the nucleus and distinct from stress granules. This suggests there are additional cellular mechanisms, along with changes in splice-activity, leading to RBM20 cardiomyopathy.

"When the RNA binding landscape of mutant RBM20 was revealed by a technology called enhanced CLIP, it mimicked the binding of other splicing factors that have been implicated in neurodegenerative diseases. These factors, when mutated, also change their activity from RNA splicing to RNA aggregation outside the nucleus," says co-author Gene Yeo, PhD, MBA, a member of the Department of Cellular and Molecular Medicine at the University of California San Diego.

"Over time, such aggregates play havoc with other cell functions, ultimately leading to the tissue-weakening of heart muscle during cardiomyopathy," Salomonis says.

"It is intriguing to note the parallels between our observations with RBM20 and recent findings in neuro-degeneration," the paper states. "Indeed, recent work has hypothesized cytoplasmic RBM20 may be similar to the cytoplasmic RNP granules associated with neurodegeneration (Schneider et al., 2020), such as TAU for Alzheimer s disease, Huntingtin for Huntington s disease, and FUS for amyotrophic lateral sclerosis (ALS)."

Next steps

Co-authors for this study also included scientists from the University of Cincinnati Department of Electrical Engineering and Computer Science, Sana Biotechnology, and the University of California San Francisco.

The co-authors say the 3D heart tissue model they've developed has the potential to be used to test new drugs to block the formation of cytoplasmic granules as a possible treatment for cardiomyopathy, even those without RBM20 mutations.

"RBM20 has been a frustrating protein to study, as animal models don't fully recapitulate human disease pathology," says lead author Aidan Fenix, PhD. "It's exciting to now have an in vitrohuman cell model of RBM20 cardiomyopathy that shows the major clinical feature of dilated cardiomyopathy--reduced contractile force. We hope these models will speed the discovery of therapies to treat RBM20 dilated cardiomyopathy."

About this study

This work was supported by grants from the National Heart, Lung, and Blood Institute (U01 HL099997, P01 HL089707, R01 HL130533, F32 HL156361-01, HL149734, R01 HL128362, R01 HL128368, R01 HL141570, R01 HL146868); the National Institute of Diabetes and Digestive and Kidney (U54DK107979-05S1); the National Science Foundation (NSF CMMI-1661730); a JSPS Grant-in-Aid for Young Scientists, and grants from NOVARTIS, the Mochida Memorial Foundation, SENSHIN Medical Research Foundation, Naito Foundation, Uehara Memorial Foundation, a Gladstone-CIRM Fellowship, and the A*STAR International Fellowship.

SOURCE Cincinnati Children's Hospital Medical Center

http://www.cincinnatichildrens.org

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Heart Tissue in a Dish Reveals New Links Between Neurodegeneration and Heart Disease - PRNewswire

Coherus BioSciences Announces CMS Has Extended Enhanced Medicare Reimbursement for UDENYCA in the 340B Hospital Setting Through Year-End 2022 -…

REDWOOD CITY, Calif., Nov. 05, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences(Coherus, Nasdaq: CHRS), today announced that the Centers for Medicare & Medicaid Services (CMS) will continue to provide increased Medicare reimbursement in the 340B outpatient hospital setting through year-end 2022 for 28 drugs, biologics and devices impacted by the COVID-19 public health emergency, including UDENYCA (pegfilgrastim-cbqv).

We applaud CMS for continuing its support for patients, providers and hospitals impacted by the COVID-19 pandemic, said Denny Lanfear, CEO of Coherus.

After transitional pass-through payment status expires for UDENYCA on March 31, 2022,CMS will provide a separate payment through the end of 2022 to maintain the same reimbursement levels for UDENYCA in the 340B outpatient hospital setting as determined through the pass-through payment program.Pass-through payment status was established by Congress to incentivize access for Medicare patients to biosimilars and other important therapeutics and devices in the hospital outpatient setting. Under the program, reimbursement for UDENYCA in the 340B hospital outpatient setting is calculated at the CMS Average Sales Price (ASP) for UDENYCA plus 6% of the ASP for Neulasta (pegfilgrastim). By comparison, Neulasta is currently reimbursed in the 340B hospital setting at the Neulasta ASP less 22.5%.

About UDENYCA UDENYCA is the #1 prescribed pegfilgrastim pre-filled syringe in the United States.

UDENYCAis a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: UDENYCAis not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Contraindications: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis

Warnings and Precautions:

Fatal splenic rupture:Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCAin patients with ARDS.

Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCAin patients with serious allergic reactions.

Sickle cell crises:Severe and sometimes fatal crises have occurred. Discontinue UDENYCAif sickle cell crisis occurs.

Glomerulonephritis:The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCAif causality is likely.

Leukocytosis:White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCAtherapy is recommended.

Thrombocytopenia:Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

Capillary Leak Syndrome:Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells:The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer:MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.

Aortitis:Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.

Nuclear Imaging:Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

Adverse Reactions:Most common adverse reactions ( 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contactCoherus BioSciencesat 1-800-4-UDENYCA (1-800-483-3692)orFDAat 1-800-FDA-1088 orwww.fda.gov/medwatch.

Full Prescribing Information available atwww.UDENYCA.com

About Coherus BioSciences

Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients lives and to deliver significant savings to the health care system. Coherus strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit http://www.coherus.com.

Coherus markets UDENYCA (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis, Humira, and Avastin, if approved.

UDENYCA is a trademark of Coherus BioSciences, Inc.

Neulasta is a registered trademark of Amgen, Inc.

Avastin and Lucentis are registered trademarks of Genentech, Inc.

Humira is a registered trademark of AbbVie Inc.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus ability to generate cash flow from its UDENYCA business; the reimbursement of UDENYCA by CMS in the 340B hospital at the rate of UDENYCA Average Sale Price + 6% of the Neulasta ASP through year-end 2022; Coherus plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus ability to prepare for projected launches through 2023 of toripalimab or of biosimilars of Humira, Avastin and Lucentis, if approved.

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus regulatory filings; the risk of FDA review issues; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus business in general, see Coherus Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

Coherus Contact Information: IR Contact: Cheston Turbyfill Coherus BioSciences, Inc. IR@coherus.com

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Coherus BioSciences Announces CMS Has Extended Enhanced Medicare Reimbursement for UDENYCA in the 340B Hospital Setting Through Year-End 2022 -...