Featured Story | By Nick Paul Taylor Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the first half of the year. read more |
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Top Stories By Nick Paul Taylor AbbVie has landed an option to buy Mitokinin for a neurodegenerative disease pipeline led by a Parkinson’s disease prospect. The option positions AbbVie to buy Mitokinin upon the completion of IND-enabling studies on the biotech’s lead PINK1 compound. read more By Ben Adams It’s been a relatively quiet few years for FogPharma, at least publicly, but now the Cambridge, Massachusetts-based biotech is revealing a major funding round. read more Sponsored By: Taconic Biosciences Humanized immune system mice are revolutionary tools for the development of oncology therapeutics, but their use has been limited for some applications by impaired human myeloid cell differentiation. read more By Amirah Al Idrus Presage Biosciences landed two more biopharma partners in Merck and Maverick Therapeutics and raised another $13 million to expand its tumor microdosing technology. Its new partners will use that tech to assess new anti-cancer medicines in phase 0 trials, a stage in drug development designed to bridge preclinical and clinical work. read more By Ben Adams Cerecor, which has a market cap of less than $400 million and some small, low-key raises and pacts over the years, saw its shares bounce around 15% premarket this morning on new phase 2 data for its experimental COVID-19 drug. read more By Ben Adams Virtual drug design tech firm Iktos has set up a new pact with Big Pharma Pfizer to tap its artificial intelligence for its discovery work. read more By Conor Hale The FDA has cleared a new type of device worn around the back of the neck by athletes ages 13 and up, to help protect them from brain injuries caused by typically lighter, but repeated, impacts during sports. read more |  | Experts in our field with 20+ years’ experience in Viral Vector & Plasmid DNA manufacture. Now part of the Cognate BioServices family, your CDMO partner from concept to commercial for cell & gene therapy products. Request a call back. |
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: 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 Download our whitepaper to learn how BC Platforms has leveraged our technical expertise to offer robust and comprehensive solutions to maximize RWD ROI. 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: Premier Research Browse the latest learnings and insights from our clinical development professionals. 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. | 
