Pink Sheet Podcast: The Big Vaccines Adcomm, AMAG Fights Makena Withdrawal
Pink Sheet reporters and editors discuss their take-aways from the recent advisory committee meeting on coronavirus vaccine development and approval, as well as the upcoming FDA hearing on Makena’s withdrawal.
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With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.
Pink Sheet reporters and editors discuss the surprise US complete response letter for a new gene therapy and the specialists who may be added to the FDA’s coronavirus vaccine advisory committee, and also look at facility inspections during the pandemic.
Pricing set somewhere down the middle as Moderna reaches deal with US government on initial supplies of its mRNA vaccine. Also, Evidence Accelerator's next joint parallel analysis projects are remdesivir in hospitalized patients and coagulopathy.