Featured Story | By Ben Adams Merck has had a torrid time with COVID-19 vaccines and a major setback with its OncoImmune-partnered pandemic med, but now, finally, it’s seeing some good news on that R&D front. read more |
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|  | Vectoring In – Viral Vector Video Series When you are ready to ramp up late stage manufacturing to go commercial, you’ll need to count on your CDMO for a great deal more than capacity. Click to hear from our experts on how to ensure your success. Learn more. |
Top Stories By Conor Hale,Ben Adams,Amirah Al Idrus,Angus Liu Each member of this year’s class of Fierce 15 stands out in a different way, but they all overcame a year of unforgettable obstacles, making each of their successes much more significant. read more By Nick Paul Taylor A phase 3 clinical trial of CytoDyn’s leronlimab in COVID-19 patients has missed its primary and all major secondary endpoints. However, CytoDyn zeroed in on a subgroup of patients and performed an “age adjustment” analysis to hail the study as evidence of the efficaciousness of leronlimab. read more By Amirah Al Idrus AnaptysBio’s anti-IL-36R drug failed a phase 2 study in palmoplantar pustulosis, a rare, inflammatory disorder that causes blisterlike sores to form on the palms of the hands and soles of the feet. The company is halting development of the drug in that indication but is pressing ahead in five others. read more By Nick Paul Taylor Seres Therapeutics has stopped enrollment in a metastatic melanoma clinical trial and deprioritized the drug. The microbiome specialist attributed the actions to slow enrollment during the pandemic and the progress of its preclinical oncology pipeline. read more By Ben Adams Johnson & Johnson recently nabbed an emergency use authorization from the FDA for its single-shot COVID-19 vaccine, but today it said its trials for the shot had largely been done virtually through IQVIA. read more By Conor Hale Using app-based video chat and remote programming features, the clinic allows physicians to digitally prescribe new treatment settings. read more By Arlene Weintraub Researchers at Harvard and Massachusetts General Hospital used a type of artificial intelligence called machine learning to identify existing drugs that might be able to prevent neuronal death in Alzheimer’s disease. The screen pulled up a list of 15 FDA-approved drugs as candidates, including Eli Lilly's JAK inhibitor Olumiant. A clinical trial will start soon. read more By Angus Liu After similar moves by fellow immuno-oncology players Bristol Myers Squibb, AstraZeneca and Merck & Co., Roche has pulled a Tecentriq bladder cancer indication amid a long-overdue FDA campaign targeting accelerated approvals that have failed in confirmatory studies. read more Enrollment Showcase | Sponsored by: University of Florida College of Pharmacy Learn about the Top 5-Ranked UF College of Pharmacy’s online graduate programs in pharmaceutical outcomes & policy. Select from five specializations, including the new pharmaceutical value assessment & communication option. Over half of graduates progress to a new role within one year. Register now. |
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Resources 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: 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: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule 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. | 
