BIO 2020 Notebook: FDA's Hahn On COVID-19 Lessons To Be Learned; NIH's Fauci On Health Care Disparities; Pfizer's Young On Forgoing Gov't Vaccine Funds
News and views from day three of BIO Digital. US FDA Commissioner Hahn asks industry to help identify best regulatory lessons from the pandemic; Pfizer’s chief business officer explains how need to move quickly in vaccine partnership with BioNTech led to decision to forgo US funding.
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Bob Temple tells the Pink Sheet that many of the drugs that sponsors are bringing forward have “not much evidence” of antiviral properties, “but it's still worth trying.” Jacqueline Corrigan-Curay emphasizes that even as FDA responds to the enormous coronavirus challenge, the agency's other work continues.
Coronavirus Notebook: US FDA Cuts Hotline Hours, Regulatory Relief May Be Permanent, Trump's Hydroxychloroquine Prescription
Dispatches from a world turned upside down include approval of more hydroxychloroquine ANDAs, a window into what post-pandemic regs at the US FDA might look like, and some bad news for night shift works who need coronavirus advice from the agency.
The US behemoth and its German partner have said that if their mRNA vaccine proves to be safe and effective, it could be ready for US distribution by the end of the year.