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Hi there. Today, we unpack Marty Makary’s Senate confirmation hearing, see a new ruling against GLP-1 compounders, examine the effects of the NIH patent freeze, and explore the tumultuous biotech job market.
The need-to-know this morning
- Nimbus Therapeutics said CEO Jeb Keiper is stepping down immediately as part of a planned transition. The company named Abbas Kazimi, its chief business officer since 2020, as Keiper’s successor.
Makary FDA hearing: More MAHA focus than regulatory policy
Marty Makary’s Senate confirmation hearing to be FDA commissioner went rather smoothly. He wasn’t pressed much on core regulatory issues; four senators asked about the abortion drug mifepristone, and just one asked about accelerated approvals and rare disease drugs. There were no questions on GLP-1 drug shortages, FDA’s regulation of AI, or lab-developed tests — all key issues for the agency these days.
“We need more humility in the medical establishment,” Makary said.
Instead the focus was on transparency, chronic disease, and agency layoffs. Makary pledged to assess FDA staffing and efficiency, supported biosimilar and generic approvals to lower costs, and promised stricter oversight on food additives and illegal vapes. But he didn’t commit to restoring DEI guidelines or rescheduling vaccine advisory meetings.
And listen to the new episode of The Readout LOUD podcast on the confirmation hearing here.
Judge rules against compounding group; Hims’ shares fall
From STAT’s Elaine Chen: A federal judge this week ruled against a compounding trade group that wanted to continue making copies of Eli Lilly’s obesity drug tirzepatide (sold under the brand names Mounjaro and Zepbound).
For background: The FDA last year took tirzepatide off its shortage list, which meant compounding pharmacies could no longer legally make copies of the branded treatment. But the Outsourcing Facility Association, a compounding trade group, sued the FDA, arguing that the agency’s move was arbitrary and unlawful. The trade group sought a preliminary injunction that would prevent the FDA from taking actions against its members making tirzepatide copies, but the judge has now denied the request. The judge’s order is sealed and could not be viewed by STAT.
In a statement, OFA chairman Lee Rosebush said the group is considering all of its options, including an appeal. He would not comment on any particular aspect of the order until it is unsealed by the court.
The ruling is a blow to compounders, which saw a surge in demand from patients over the last two years as patients could not access the branded treatments due to shortages and their high costs. The same trade group has also filed a lawsuit against the FDA for recently taking Novo Nordisk’s semaglutide (sold under the brand names Ozempic and Wegovy) off its shortage list.
Hims and Hers has been one of the most prominent telehealth companies connecting patients to compounded weight loss drugs.
Though it was not offering compounded tirzepatide and recently said it would stop making exact copies of semaglutide, the company said it will still prescribe other forms of compounded semaglutide “when there is clinical necessity for that personalization.” Though the judge’s ruling does not have a direct impact on Hims, it indicates the difficult legal environment for companies involved with compounding. Hims’ shares dropped 16% yesterday.
The ruling, meanwhile, represents a win for Lilly and Novo, which have both been trying to combat the rise of compounding. Both have started selling their drugs direct-to-consumer at a lower price, as a way to draw patients away from compounders. Just yesterday, the telehealth company Teladoc announced a new partnership with Lilly’s DTC platform that allows Teladoc users to get streamlined access to tirzepatide.
NIH patent freeze stalls biomedical progress
The Trump administration’s clampdown on NIH external communications and new contracts has halted patent filings and licensing, disrupting biomedical innovation, STAT’s Megan Molteni writes. Since Jan. 29, NIH tech transfer employees have been barred from negotiating agreements, delaying vaccine and drug development.
Several tech transfer staff have been laid off, which is further straining the agency’s ability to protect and commercialize taxpayer-funded discoveries.
“Bench to bedside is such a complicated ladder — no company or university or even the federal government has all the expertise needed to get it from point A to point B,” one NIAID patent specialist told STAT. “It’s absolutely mind-boggling to take away so many rungs of that ladder and think someone will still be able to climb it.”
Volatility is the norm for biotech careers now
The biotech industry is getting more and more niche: Startups focus on single assets, aiming to be gobbled up by bigger fish. Large pharmas increasingly prefer bolt-on deals, while venture capital funding is highly conditional, making job stability even harder, opines Cambridge-based business development professional Gairik Sachdeva.
“Biotech employees can prepare for this new rollercoaster normal by picking a niche in this increasingly specialized industry and then fortifying their skill sets to support milestones most relevant to companies in that niche,” he writes in a new First Opinion piece.
Career flux is the new norm, Sachdeva says — and those who continuously adapt and expand their expertise are the ones that will thrive in this rapidly evolving industry.
More reads
- NIH puts former Sexual & Gender Minority Research Office employees on administrative leave, STAT
- Q&A: How ‘blast zone’ of gender politics is hurting research on women’s health, STAT
- Novo Nordisk’s rare disease ‘company within a company’ has an open goal in sickle cell, Endpoints
- J&J to stop late-stage study of add-on depression drug, Reuters