Pink Sheet Podcast: COVID-19 Vaccine Strain Selection, Small FDA Advisory Committees, OPDP Untitled Letter
Pink Sheet reporters and editors consider the upcoming COVID-19 vaccination campaign, the virtue of advisory committees with only a few members, and the first FDA drug advertising untitled letter in a year.
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Pink Sheet Podcast: Adcomm Rejects NurOwn For ALS, FDA In Shutdown Mode, Limited Price Negotiation Savings
Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.
Pink Sheet Podcast: FTC Ends Amgen-Horizon Case, New Ultra-Rare Cancer Partnership, Generic Applications Lag
Pink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics, a proposed public-private partnership to develop ultra-rare cancer drugs, and a slow-down in ANDA submissions to the US Food and Drug Administration.
We used the US holiday weekend to upgrade our platform, so there are lots of stories to catch you up on, from Korean regulatory legislation to German exclusivity litigation.