Senior reporter Max Bayer has a juicy report this week on the biotech forces that helped push out former FDA Commissioner Marty Makary. It’s a must read. At the center is Biohaven CEO Vlad Coric who, after his company’s rare disease drug was rejected last year, appealed to Makary directly to find a path forward. 

But nothing seemed to steer Makary toward flexibility, according to Max’s sources, who spoke on condition of anonymity. As other rejections piled up — particularly in rare disease — other jilted biotech companies made their case directly to the Trump administration in Makary’s final weeks. They argued Makary was unreliable and doing a poor job leading the agency. For Biohaven, the meeting with Makary was the breaking point. 

Biohaven and several other companies were part of a loose group that coordinated outreach and messaging to the White House and lawmakers on Capitol Hill. It created a new era in the relationship between the industry and its regulator. Read Max’s full story here.

Elsewhere in Washington, the FDA's unreleased Covid-19 vaccine deaths report was published by Sen. Ron Johnson (R-WI) after he received it from HHS. The agency’s formal analysis appears to confirm reporting by Endpoints News that the actual number of deaths was lower, and the cases less certain, than what former CBER Director Vinay Prasad had initially portrayed.

And the money keeps flowing for biotechs built around clinical-stage medicines licensed from other companies. A cohort of premier investor names is behind the latest megaround newcomer. Mountainfield Venture Partners, Frazier, Forbion, Venrock and others are backing cAMPfield Therapeutics with $180 million, according to a LinkedIn post from CEO Bill Gerhart. He appears to have edited the post after being contacted by Endpoints News, which broke the news. The company might be linked to a PDE4 inhibitor that’s part of a vTv Therapeutics and Newsoara Biopharma pact. The experimental medicine is in Phase 3 in psoriasis in China. 

Many developers of obesity drugs are fond of saying that it’s not a competition to produce the strongest and fastest levels of weight loss. They had better hope they’re right, because if it is a competition, Eli Lilly is winning, senior biopharma journalist Elizabeth Cairns wrote this week. 

Lilly’s triple agonist retatrutide allowed obesity patients to lose about a quarter of their weight after taking the shot for 80 weeks — about a year and a half. This is the strongest weight loss data yet in a Phase 3 trial in a pure obesity population. But retatrutide is still a few years away from market, and won’t do much in the short term to offset the seemingly slow launch of Lilly’s obesity pill Foundayo.

Retatrutide is the most advanced triple agonist — a drug that activates the receptors for GLP-1, GIP and glucagon. Novo Nordisk has a similar shot which it licensed from the Chinese biotech United Laboratories, and this too has been highly effective, but the data came from a China-based Phase 2 study and the dose used was not disclosed.

Merck is seeking to maintain a significant presence in oncology once Keytruda hits its 2028 patent cliff, and its ADC sac-TMT — partnered with Kelun-Biotech — is expected to play a large part. This week, sac-TMT got its first Phase 3 win in a global trial, and it came ahead of schedule. The success came in certain patients with advanced endometrial cancer and represents the first opportunity for sac-TMT to face US regulators.

The annual ASCO meeting is scheduled for next weekend, but most abstracts for the meeting were released this week. Among the highlights: new data for PD-1xVEGF bispecifics that aim to compete with the field’s leaders Summit Therapeutics and Akeso, as well as further sac-TMT data in first-line lung cancer showing a 65% reduction in the risk of disease progression or death.