Featured Story | By Ben Adams AstraZeneca’s executive vice president of oncology R&D José Baselga, M.D., Ph.D., 61, has passed away. read more |
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Top Stories By Ben Adams Pfizer and Eli Lilly’s long journey to a potential FDA approval for tanezumab still looked rocky today after review documents from the regulator cast doubt over its safety. read more By Amirah Al Idrus Odonate Therapeutics is ending development of its oral chemotherapy drug and closing up shop after the FDA deemed the drug’s clinical data “unlikely to support FDA approval.” As it winds down its operations, the company will work with clinical sites to switch patients participating in its clinical trials to alternative treatments. read more Sponsored By: GT Biopharma, Inc. Could native, non-functioning NK cells in cancer patients be rescued and revived by a novel, off-the-shelf immuno-oncology therapeutic that is also a pervasive serial cancer killer? The Data Says Yes. read more By Amirah Al Idrus Private biopharma companies raised nearly $20 billion in 2020, blowing past the record $17.9 billion set in 2018. Here are the top 10 fundraising rounds, which include some "truly monstrous" financings like Sana Biotechnology's eye-watering $700 million series and Lyell Immunopharma's $493 million raise. read more Sponsored By: Catalent Cell & Gene Therapy Gene therapy manufacturing and clinical supply strategies should be in place early to avoid potential late-stage development delays. read more By Nick Paul Taylor Daiichi Sankyo has begun a phase 1/2 clinical trial of an mRNA vaccine against COVID-19. The vaccine is set to come to market well after leading prophylactics but gives Japan a chance to establish its own countermeasures for COVID-19 and future health crises. read more By Amirah Al Idrus BridgeBio Pharma’s treatment for a rare hormonal disorder helped patients reach normal levels of that hormone as well as of calcium, phosphorus and magnesium in their blood, early phase 2 data show. The company’s next stop will be a meeting with regulators ahead of a phase 3 study to figure out the treatment’s path to patients. read more By Nick Paul Taylor XyloCor Therapeutics has raised $22.6 million to study a gene therapy designed to deliver VEGF to heart cells. The financing, which swells the series A to $41.9 million, positions XyloCor to study its lead candidate in patients undergoing coronary artery bypass graft surgery. read more By Conor Hale Stroke-spotting software developer Viz.ai has raised $71 million to help expand its artificial intelligence programs into other acute care areas—including cardiovascular, pulmonary and trauma care—amid plans to take its business to new global markets. read more By Arlene Weintraub People who suffer heart attacks frequently progress to chronic heart failure due to scarring and inflammation that hampers heart function. Researchers at Baylor College of Medicine showed that a small-molecule inhibitor of steroid receptor coactivators could prevent that progression in mice. read more By Eric Sagonowsky With the U.S. racing against new COVID-19 variants, a fourth shot looks to be on its way. In a phase 3 trial in the U.S., Peru and Chile, AstraZeneca’s vaccine—authorized in Europe and beyond, but not yet in the U.S.—posted 79% efficacy against symptomatic COVID-19 and 100% against severe disease. read more Resources Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: OCT Clinical Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical. Sponsored By: Almac Clinical Technologies This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: AmerisourceBergen Corporation Unlock product potential by making the most of your commercialization investments. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: Acorn AI Unlock competitive advantage with AI and advanced analytics. Sponsored By: EVERSANA Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Thermo Fisher Scientific Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain. Sponsored By: Blue Matter, strategic consultants in the life sciences A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones. Sponsored by: Baxter BioPharma Solutions While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. | 
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