Featured Story | By Nick Paul Taylor The FDA has accepted Amgen’s KRAS G12C inhibitor sotorasib for priority review. Amgen is set to learn whether the FDA will approve the landmark drug in non-small cell lung cancer (NSCLC) by the middle of August. read more |
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Top Stories By Ben Adams Last year, Big Pharma GlaxoSmithKline and George Scangos’ biotech Vir joined forces against COVID-19. Now, the pair is turning its crosshairs on a broader range of respiratory diseases. read more By Amirah Al Idrus Novartis is adding sickle cell disease to its gene therapy stable through a partnership with the Bill & Melinda Gates Foundation. The latter will support a research team at the Swiss Pharma dedicated to discovering and developing a one-and-done in vivo treatment that can be given easily to patients all over the world. read more By Nick Paul Taylor Two more phase 3 clinical trials of Eli Lilly’s tirzepatide in Type 2 diabetics have met their primary endpoints. The studies, like a trial that read out late last year, linked the dual GIP/GLP-1 agonist to significant declines in blood sugar and body weight. read more By Amirah Al Idrus Affinia Therapeutics is rounding out its executive team with a pair of seasoned executives as it aims for the clinic. Chief Scientific Officer Charles Albright, Ph.D., is reprising the role he held at Editas Medicines until last month, while Chief Medical Officer Petra Kaufmann, M.D., arrives from Novartis Gene Therapies, where she oversaw clinical development, analytics and translational medicine. read more By Angus Liu Scientists at China’s National center for Nanoscience and Technology have designed a hydrogel to deliver an mRNA vaccine with an immune-stimulating adjuvant. When injected into mice with melanoma, the vaccine stayed active for at least 30 days, inhibiting tumor growth and preventing metastasis. read more By Amirah Al Idrus Regenerative tissue developer Humacyte is going public through a special purpose acquisition company, or SPAC, and raising $275 million in the process. Under the all-stock deal, the combined company will receive up to $100 million from the SPAC as well as $175 million through a private round. The company will trade on the Nasdaq Capital Market under the ticker “HUMA.” read more By Ben Adams Sanofi is funneling €2.5 million into French clinical trial simulation specialist Novadiscovery as it looks to beef up its COVID-19 trial response. 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: 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: Medidata, a Dassault Systèmes company 8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook. Sponsored By: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored By: Acorn AI, a Medidata Company Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. Sponsored By: Outer Edge Technology Criminals Are Actively Exploiting The CV-19 Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become A Cybercrime Statistic -- Make These Cost-Effective IT Changes Now! Sponsored by: Cytiva It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders. 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. Learn what it takes to get a drug developed and approved February 23-24, 2021 | 12 p.m. EST / 9 a.m. PST For non-scientists. Learn the science driving biopharma. February 25-26, 2021 | 9 a.m. EST / 6 a.m. PST BD&L Summit for Life Sciences March 9–10, 2021 | Virtual Event Learn what it takes to get a drug developed and approved March 9-10, 2021 | 9 a.m. EST / 6 a.m. PST Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 12 p.m. EST / 9 a.m. PST Learn what it takes to get a drug developed and approved April 13-14, 2021 | 12 p.m. EST / 9 a.m. PST
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