Nine recipients of priority review vouchers named

The Food and Drug Administration yesterday named the first nine recipients of the new Commissioner's National Priority Review vouchers, a program offering one- to two-month drug review timelines and enhanced communications with agency staff.

Among the recipients: Sanofi, for teplizumab, a monoclonal antibody being developed to treat Type 1 diabetes; Regeneron, for DB-OTO, a gene therapy being developed to treat a rare form of deafness; and Revolution Medicines, for RMC-6236, a drug being developed to treat pancreatic cancer.

Read more from STAT's Lizzy Lawrence on the full list.

biotech

CEOs: FDA upheaval will impact drug development

Speaking at the STAT Summit, a pair of biotech executives warned that turmoil within the FDA is endangering drug development after recent rejections that they say blindsided them.

Replimune CEO Sushil Patel and Capricor Therapeutics CEO Linda Marabán said their applications — once seemingly on track for approval — were derailed amid sweeping leadership changes and what they characterized as political interference following the Trump administration's return.

The departures of top regulators, including cell and gene therapy overseer Nicole Verdun, and shifting attitudes under Commissioner Marty Makary have left companies guessing about the agency's priorities, they said.

"It is going to kill drug development if you don't have consistency and transparency," Patel said. "It's really going to make it very difficult for us to bring innovative treatments to patients faster."

podcast

Biotech vet Clive Meanwell on pricing and the obesity market

On this week's episode of "The Readout LOUD": an interview wtih veteran biotech executive and company founder Clive Meanwell. Pfizer recently acquired one of Meanwell's companies, the obesity drug developer Metsera, for just under $5 billion.

Your favorite podcast co-hosts have been extra busy this week moderating panel discussions at the STAT Summit in Boston, so we prerecorded this interview with Meanwell on Oct. 8. A regular "Readout LOUD" episode will return next week.

In our chat, Meanwell offered his perspectives on the evolving obesity drug market, and continued need for drugs to treat diseases with large prevalence, which he's doing with his latest venture, called Corsera Health. Meanwell also had thoughts on drug pricing policies both in the U.S. and the U.K.

Listen here.

EXECUTIVES

Lilly CSO defends hiring of ex-FDA chief Peter Marks

Eli Lilly's chief scientific officer, Dan Skovronsky, pushed back against criticism over the company's recent hiring of former FDA official Peter Marks. Speaking at the STAT Summit, he argued that the so-called revolving door between government and industry can benefit society by advancing drug innovation.

"I understand the comments," said Skovronksy, who is also president of Lilly's research labs. "On the other hand, what kind of society would we live in if government jobs were a one-way door and people leave and they're unemployed for the rest of your life?"

Skovronsky also defended trial results for Lilly's obesity pill orforglipron, which delivered 11% weight loss — below Wall Street's hopes but, he said, consistent with the drug's goals for a medication that could provide wider access than injectables.