Drug Fix: 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 (0:41), the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy (14:32), and a plan to add more temporary members to agency advisory committees (24:55) … as well as a little bit of “The Simpsons.” Read More In The Pink Sheet Everything’s Coming Up Pfizer: The Biggest Of Pharma Firms Leads Industry In Pending Applications For US FDA Approval https://pink.pharmaintelligence.informa.com/PS148271/Everythings-Coming-Up-Pfizer-The-Biggest-Of-Pharma-Firms-Leads-Industry-In-Pending-Applications-For-US-FDA-Approval Big Pharma At US FDA: A Regulatory Scorecard https://pink.pharmaintelligence.informa.com/PS148265/Big-Pharma-At-US-FDA-A-Regulatory-Scorecard Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters https://pink.pharmaintelligence.informa.com/PS148280/Lilly-Unlucky-Lilly-Leads-Big-Pharma-In-US-FDA-Complete-Response-Letters Everybody Stumbles: US FDA Complete Response Letters To Big Pharma https://pink.pharmaintelligence.informa.com/PS148279/Everybody-Stumbles-US-FDA-Complete-Response-Letters-To-Big-Pharma Sarepta’s DMD Gene Therapy: Approval Delayed And Indication Narrowed, But Still On Track https://pink.pharmaintelligence.informa.com/PS148268/Sareptas-DMD-Gene-Therapy-Approval-Delayed-And-Indication-Narrowed-But-Still-On-Track Expect More Temporary Members Voting In US FDA Advisory Committees https://pink.pharmaintelligence.informa.com/PS148243/Expect-More-Temporary-Members-Voting-In-US-FDA-Advisory-Committees