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

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