Featured Story | By Nick Paul Taylor A bluebird bio investigation has found a LentiGlobin gene therapy is “very unlikely” to have caused the acute myeloid leukemia (AML) that affected a recipient of a sickle cell treatment. Bluebird is now working with regulators to resume clinical trials in beta-thalassemia and sickle cell disease. 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 Amirah Al Idrus Grifols picked up a 44% stake in GigaGen in 2017 when the duo teamed up to develop polyclonal antibodies under a $50 million pact. Now, the Spanish pharma is dropping $80 million to acquire the remaining 56% of its partner. GigaGen brings with it a pipeline of recombinant polyclonal antibodies in development for primary immune deficiency and infectious diseases such as COVID-19. read more By Amirah Al Idrus A year and a half after betting $950 million on Semma Therapeutics and its stem cell-based diabetes treatments, Vertex is ushering one of those programs into the clinic and grabbing a fast-track tag from the FDA. It will test the treatment in patients with Type 1 diabetes who don't experience the typical warning signs when their blood sugar drops to very low levels. read more By Ben Adams The Coalition for Epidemic Preparedness Innovations is funneling $33 million into VBI Vaccines so it can get to work on prepping for new and emerging variants of SARS-CoV-02 that could lessen the efficacy of authorized vaccines. read more By Nick Paul Taylor AgomAb Therapeutics has raised $74 million to advance regenerative pathway modulators in inflammatory, metabolic and fibrotic diseases. The pipeline is led by an HGF-mimetic agonistic antibody developed using argenx’s platform. read more By Conor Hale Deerfield Management has teamed up with medtech incubator Coridea to establish a new medical innovation firm in New York City. read more By Eric Sagonowsky Lilly’s COVID-19 antibody combo already boasts an FDA authorization for patients at a high risk of developing severe disease, but now it has even stronger data backing the duo. And it's the best data any coronavirus therapy has delivered so far. 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: 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: 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. | 
