Featured Story | By Amirah Al Idrus After dozens of trials over more than 15 years, Pfizer and Eli Lilly’s osteoarthritis hopeful was poised for an FDA decision in December 2020—that is, until the agency called a panel of outside experts to chew over the drug’s application. That panel came down against the drug in a vote on Thursday because of major safety risks and an inadequate plan to manage them. read more |
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Top Stories By Ben Adams Bristol Myers Squibb has released a very top-line look at the first late-stage data for a lymphocyte-activation gene 3 asset, but with no actual figures there’s a lag before we find out just how well it did. read more By Nick Paul Taylor Eliem Therapeutics has exited stealth with $80 million and plans to treat chronic pain, depression, epilepsy and anxiety. The Anglo-American startup will use the money to advance a pipeline led by a palmitoylethanolamide prodrug for the treatment of chronic pain. 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 Ben Adams Venture capitalist firm RiverVest Venture Partners has closed its fifth fund with a $275 million raise, bumping up its total over the years to a meaty $1.6 billion. read more By Nick Paul Taylor Apnimed has raised $25 million to develop a pharmacological treatment for obstructive sleep apnea (OSA). The series B financing will enable Apnimed to deliver data from phase 2 trials of its oral drug candidate in the second quarter and push on into late-stage development. read more By Ben Adams Fate Therapeutics’ long-standing Chief Scientific Officer Daniel Shoemaker, Ph.D., will be leaving the cell therapy biotech this summer. read more By Amirah Al Idrus Antibody biotech Lassen Therapeutics is joining forces with Cedars Sinai Medical Center to study the role of the cytokine IL-11 in lung fibrosis and whether blocking IL-11 signaling could be useful in treating this bucket of diseases in preclinical models. read more By Eric Sagonowsky AstraZeneca created a COVID-19 vaccine data controversy this week by reportedly selecting the most favorable data to tout on its program, a move independent data monitors publicly flagged in a middle-of-the-night missive. Now, with a speedy data update and analysis, AstraZeneca says it can “confirm” the vaccine’s phase 3 success. read more By Conor Hale Thermo Fisher Scientific is rolling out a new device designed to monitor rooms for airborne viruses, including the coronavirus behind COVID-19. 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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