Featured Story | By Ben Adams China’s Legend Biotech and Janssen have finished off the rolling submission to the FDA for their partnered cell therapy hopeful cilta-cel. read more |
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Top Stories By Nick Paul Taylor A phase 3 clinical trial of concentrated levels of convalescent COVID-19 antibodies has missed its endpoints. The failure marks the end of a CSL Behring-Takeda alliance that set out one year ago to develop a plasma-derived treatment for COVID-19. read more By Nick Paul Taylor A government watchdog has called for an investigation into the “unprecedented and inappropriate close collaboration” between Biogen and the FDA on the aducanumab filing in Alzheimer’s disease. read more Sponsored By: BioIVT Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are common pathologies without specialized therapeutics, but new models may provide opportunities for drug discovery. read more By Amirah Al Idrus Rain Therapeutics catapulted itself toward pivotal development in September when it picked up a cancer drug from Daiichi Sankyo. Now, the California biotech aims to raise up to $100 million in its Wall Street debut, which will fuel a phase 3 study for the asset in liposarcoma, a cancer that occurs in the body’s fat cells, and a phase 2 study in solid tumors. read more By Ben Adams A founding member of eye disease and gene therapy biotech Iveric Bio, David Guyer, M.D., is stepping down from his executive chair role and leaving the board of the company he helped build. read more By Eric Sagonowsky Johnson & Johnson is in. Emergent BioSolutions is out—at least when it comes to managing its own plant in Baltimore. After a manufacturing mix-up forced J&J to discard up to 15 million doses of its vaccine made there—and after news emerged of Emergent's history of violations there—the U.S. government stepped in, handing control of the plant to the pharma giant. read more By Arlene Weintraub A Penn team found that Pfizer’s lung cancer treatment Vizimpro (dacomitinib), the antibiotic salinomycin and anti-rejection drug cyclosporine inhibited SARS-CoV-2 in respiratory cells. The study also shed light on the varied mechanisms the virus uses to invade different types of cells. read more Resources Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: PerkinElmer Informatics Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes. 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: PulsePoint Access this guide for the latest insights into how marketers can use data, technology, and personalized messaging to build vaccine confidence and drive successful immunization efforts. 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: 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: 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. | 
