Pink Sheet Podcast: Big Pharma’s US FDA Scorecard, Sarepta’s DMD Gene Therapy Delay, US FDA Adcomm Reforms
Pink Sheet reporters and editors discuss the largest pharma companies’ pending applications, the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy, and a plan to add more temporary members to agency advisory committees … as well as a little bit of “The Simpsons.”
You may also be interested in...
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.
Pink Sheet Podcast: What We Learned From The First Medicare Price Negotiation List, Pepaxto Withdrawal Update
Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process.