Stock Watch: Drug Safety In The Spotlight

Three FDA Clinical Holds In The Shortened Thanksgiving Week May Have Wider Implications

Are three FDA clinical holds in less than four days a symptom of lax safety programs at some biotech companies? And what does the latest publication on Aduhelm say about the relationship between safety and accelerated approval?

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

As portfolio managers and analysts headed off to Thanksgiving family reunions, this year accompanied by clutches of lateral flow tests, the news flow in life sciences was expected to dwindle. On the Wednesday before Thanksgiving this year, that plan went awry with two companies announcing FDA clinical holds.

In a Wednesday morning update on its Phase Ib study of the menin inhibitor KO-539 in relapsed or refractory acute...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Stock Watch

More from Business