Amgen, AstraZeneca's asthma drug tezepelumab fails phase 3 Vertex joins Skyhawk's roster of A-list partners, securing options on RNA splicing modulators Looking ahead to 2021: Hope for life beyond COVID-19 but shaped by the pandemic 2021 forecast: Hahn heads toward FDA exit after short, dramatic tenure as commissioner 2021 forecast: Clinical trial diversity has long been a thorn in biopharma's side, but 2020 could turn things around 2021 forecast: COVID-19 brings infectious disease R&D out of the wilderness 2021 forecast: In spite of COVID-19—and partly because of it—biotech IPOs have a record year 2021 forecast: The rise and rise of the virtual trial model How novel combos could overcome resistance to targeted drugs in leukemia, solid tumors and more After 2020, telehealth use accelerates from 'digital PPE' toward mainstream care Featured Story | By Nick Paul Taylor A phase 3 clinical trial of Amgen and AstraZeneca’s asthma candidate tezepelumab has missed its primary endpoint. The failure comes weeks after tezepelumab hit the endpoint in another phase 3, leaving the partners with a mixed data set they still plan to use to seek regulatory approvals next year. read more |
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Top Stories By Nick Paul Taylor Vertex has secured exclusive options to license Skyhawk Therapeutics’ candidates that modulate RNA splicing. The deal will see Vertex pay Skyhawk $40 million upfront and commit to up to $2.2 billion in milestones to secure options on multiple small molecules. read more By Ben Adams The global pandemic has put the spotlight on the life science industry, and, for the most part, it has stood up to the intensity of its glare. read more By Nick Paul Taylor When Stephen Hahn was confirmed as commissioner of the FDA one year ago, vaping, described at the time by one physician as the “biggest public health crisis of the Trump administration,” was the most pressing item in his in tray. read more By Amirah Al Idrus It seems like a no-brainer. If a company wants to treat everyone who has a certain disease with its new drug, then it should test that drug in, well, everyone. read more By Nick Paul Taylor Infectious disease was a long way down the list of the hottest areas of biopharma R&D going into 2020, but a global pandemic changed all that. read more By Amirah Al Idrus It didn’t look good for IPOs when the pandemic took hold. COVID-19, social distancing and general uncertainty upended the public markets, leading Renaissance Capital to predict IPOs to “grind to a virtual halt” in the spring. read more By Ben Adams A virtual, decentralized or siteless clinical trial model; however you want to describe it, a new way of running studies is here, and it wants to stay. read more By Arlene Weintraub Researchers at Cincinnati Children's and UCLA have preclinical evidence suggesting that combining mTOR or BRAF inhibitors with other targeted treatments could overcome resistance in several cancers. The findings could guide research aimed at finding new treatments for leukemia and melanoma, as well as lung, pancreatic and colon cancer. read more By Conor Hale The promise of a digital revolution in healthcare has been described as “just a few years away” for the better part of a decade, but the spread of COVID-19 in 2020 has spurred that transformation’s slow trot into a full gallop. read more Resources Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: GenScript A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields. 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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 Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. 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. 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