FDA officials want to reform the agency's accelerated approvals program, but Paul Hastings, chair of one of biotech's leading trade organizations, has some thoughts. Reforms could limit innovation, Hastings argues, but data suggest the program could be improved. We'll discuss the tug and pull between regulators and businesses.
But that's not all. A Vertex Pharmaceuticals diabetes therapy is back on track. Two months ago, the FDA placed a clinical hold on the drug, but now a trial is underway. And Orchestra BioMed has had a busy week with a SPAC deal and a Medtronic partnership. We'll cover that, plus this week's headlines.
To learn more about the topics in this episode:
- Orchestra BioMed cues up Medtronic partnership, $400M SPAC deal
- Vertex's Type 1 diabetes cell therapy heads back to clinic after FDA hold lifted
- Dyne another day: DMD therapy back on track after FDA lifts clinical hold
- Gun-shy on accelerated approvals, FDA will convene a 2nd expert panel meeting to reconsider Amylyx’s ALS candidate
- Biogen-Eisai go for another biomarker approval in Alzheimer's with lecanemab—and snag priority review
The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.