🤝Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, GSK, Gilead, Merck, Novartis and Sanofi are the latest companies to announce drug pricing deals with the Trump administration. A senior administration official predicted major reductions in Medicaid prices as a result of the latest deals, which Zachary Brennan detailed here. And all of the companies have also agreed that any new product launches will come at the MFN-based prices. The White House plans to launch a new government site early next year, known as TrumpRx, to help patients purchase drugs directly at discounted rates. 

📋Investigator-initiated trials — or IITs — have grown increasingly popular among China researchers, and Western drugmakers working on genetic medicines want in, Endpoints’ Lei Lei Wu and Ryan Cross reported. The small, cheap, quick trials have played a major part in how China became a competitive force in cell and gene therapy.  

Unlike a traditional clinical trial, which requires approval from national regulators, IITs may only need clearance from the Chinese research hospital running the study. They also benefit from looser manufacturing requirements. And while drug regulators often require companies to monitor patients for long periods before ramping up to higher doses, the turnaround is shorter in an IIT. 

IITs can’t be used for approval. But they can help companies see whether their medicines are promising, or allow them to “fail fast,” Imviva Biotech CEO Lu Han told Endpoints. They can also be used to help attract new backing. EsoBiotec used an IIT to treat its first multiple myeloma patient in November 2024 and quickly showed that its therapy could keep the blood cancer at bay. Just months later, AstraZeneca said it planned to buy the company for $425 million.

“Everybody in biotech is reevaluating how they work with China,” said Emile Nuwaysir, CEO of the recently launched Cambridge, MA-based genetic medicine startup Stylus Medicine. He said Stylus is considering a China IIT for its first clinical trial. 

☕An ambitious AI biotech startup pulled in some new cash this week, effectively giving it unicorn status. Chai Discovery closed a $130 million Series B at a $1.3 billion valuation, continuing a furious fundraising pace since being founded last year. The round was co-led by Oak HC/FT and General Catalyst. Other investors included Thrive Capital, OpenAI and Dimension Capital.

Chai publicly launched in 2024 with a $30 million seed round carrying a $150 million valuation. The company then closed a $70 million Series A round this August at a $550 million valuation and is now taking another sizable jump just four months later.

Vivek Ramaswamy, the former Roivant CEO and presidential candidate, appeared on the board of a private chronic pain biotech this week. Ramaswamy, now running for governor of Ohio in next year’s election, is a co-founder, investor in and board member at Ambros Therapeutics. Ambros raised $125 million and hopes to begin a Phase 3 study in 2026 for its lead program, neridronate, in complex regional pain syndrome type 1, or CRPS-1.

In somewhat classic Ramaswamy fashion, this isn’t neridronate’s first go-around at an approval. The drug has been approved for CRPS for more than a decade in Italy, but German drugmaker Grünenthal discontinued two Phase 3 studies in 2019. The new attempt harkens back to the business model Ramaswamy established at Roivant: taking older, less expensive drugs and running new, better studies for them. There are currently no FDA-approved treatments for CRPS.