
Sign up to save your podcasts
Or
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:
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.
See omnystudio.com/listener for privacy information.
3.8
88 ratings
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:
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.
See omnystudio.com/listener for privacy information.
1,753 Listeners
381 Listeners
1,034 Listeners
991 Listeners
1,789 Listeners
375 Listeners
122 Listeners
318 Listeners
171 Listeners
876 Listeners
88 Listeners
29 Listeners
147 Listeners
10 Listeners
51 Listeners