The 4pm Friday news dump is BACK

Someone at Novo Nordisk failed to pay a $450 maintenance fee, which would have kept its patent on Ozempic in force for another two years... A very expensive mistake!

We all know it's tough out there in biotech land. Down rounds, IPO window shut, Trumpster fires, all of that. But the startups keep coming and there are great people with great science doing great things. We celebrate that every year with the Endpoints 11, and we'd like to hear

The Alliance for Regenerative Medicine said it’s “deeply disappointed” by the removal of Verdun and Anatol from OTP. IND/therapy approvals now will need sign off from CBER chief Vinay Prasad endpoints.news/fdas-top-cell-…

More high-level regulators ousted at the #FDA. From Zach Brennan endpoints.news/fdas-top-cell-…

This is a good thread:

Thank you to Max Bayer and Andrew Dunn for filing the seat for me! I'll be off for a few weeks but we'll likely still have a few episodes rolling out...

Can't let the moment pass. Today marks the 9th anniversary of Endpoints News, after Arsalan Arif and I along with 2 stalwarts -- Shehla Shakoor and Igor Yavych -- took a leap of faith and launched the pub. No backers. No money. Just a real yearning to make our own way, in our

Incredible reporting from Andrew Dunn: FDA chief Makary sought rejection of KalVista's drug - in normal times this is resignation territory endpoints.news/sources-fda-ch…

🚨 alarm-worthy scoop 🚨 Andrew Dunn reports that Dr. Marty Makary personally sought the rejection of KalVista's drug. Scientists pushed back and sources described the move as "extraordinary interference into the agency’s day-to-day operations." endpoints.news/sources-fda-ch…

This is very concerning. Endpoints reports that FDA chief Makary sought rejection of KalVista's drug after the company said FDA staffing issues were resulting in delays to its application. According to Endpoints, legal arguments were used to walk him back from preparing a

Andrew Dunn Dr. Marty Makary live look

Must-read story about what's really going on behind the scene at FDA right now:

If you work at the FDA, I am interested to hear more about your perspective. Please consider reaching out to me on Signal: my username is adunn123.30 endpoints.news/sources-fda-ch…

We want to hear from people involved in the KalVista app and anything similar at FDA. Our team is on Signal and will protect your confidentiality:

I keep asking people in VC and pharma how they think the AI/techbio startups exit (are they drug companies? Acquihires? Platforms bought by pharma? Service providers?) and I've never really heard a convincing or confident answer.

This has turned into an annual summer tradition of mine — analyzing compensation trends across the biopharma world In today's story, I analyzed 475 CEO pay packages, finding the 20 highest-paid for 2024: endpoints.news/the-highest-pa…

Want to know who makes what in biopharma? Andy's analysis is a must-read (and tomorrow's story is even more so...)