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Morning. As we speak, we have a look at the implications of BARDA chopping a serious vaccine contract with Moderna, hear why former FDA chief Scott Gottlieb thinks company layoffs will impede progress on decreasing drug costs, and extra.
The necessity-to-know this morning
- Intellia Therapeutics disclosed a case of extreme liver toxicity in a affected person handled with its experimental, CRISPR-based remedy for ATTR-CM, a progressive coronary heart situation. The affected person didn’t expertise any signs and measures of liver toxicity had been resolving, the corporate stated. Nonetheless, Intellia’s inventory value fell on issues {that a} threat of liver toxicity might hamper enrollment in its ongoing Section 3 examine, or threaten the viability of the one-time therapy given the approval of different, efficient medication for the illness.
- Keros Therapeutics, a biotech at the moment engaged in a public combat with certainly one of its largest shareholders over the long run route of the corporate, stated it was shelving an experimental drug for a lung situation and decreasing its workforce by 45% to scale back working prices.
- Merck and Daiichi Sankyo withdrew their FDA advertising utility for patritumab deruxtecan in search of accelerated approval as a possible therapy for EGFR-mutated non-small cell lung most cancers. The choice to tug the submitting was made after the drug didn’t delay survival in a Section 3 examine.
HHS drops Moderna pandemic flu vaccine deal
In a politically charged determination that consultants say undercuts pandemic preparedness, HHS has canceled a virtually $600 million contract with Moderna to develop mRNA-based vaccines for potential pandemic flu strains like H5N1, citing security issues regardless of a robust immune response in early trials.
“In a quickly increasing pandemic, time issues. … The earlier the inhabitants is protected against a deadly virus the extra lives that might be saved. Of its many options, what mRNA expertise offered most is pace,” stated Bruce Gellin, a former director of the Nationwide Vaccine Program Workplace within the Bush and Obama administrations.
Moderna, reeling from its plummeting inventory and shifting market prospects, says it should search different paths ahead.
Put up-TIGIT flop, iTeos Therapeutics is shuttering
Immuno-oncology participant iTeos Therapeutics is shutting down, simply weeks after scrapping its TIGIT program with GSK as a result of lackluster scientific information. The corporate ended the primary quarter of 2025 with $624.3 million in hand and a number of other belongings, together with two early-stage oncology packages and a preclinical weight problems candidate. Its plan now could be to return as a lot capital as doable to shareholders. Buyers are happy: Its inventory jumped 28% on the information yesterday.
TIGIT as an immunotherapy goal had been overestimated for years, however it’s been largely disappointing. BeiGene, for example, deserted its personal TIGIT-targeting lung most cancers drug ociperlimab simply final month. Roche confronted the same TIGIT setback late final yr.
Vivodyne raises $40M to reinvent preclinical testing
Practically twenty years after serving to pioneer organs-on-chips, bioengineer Dan Huh is again with a extra bold imaginative and prescient: biologically complicated, AI-analyzed “lab-grown biopsies” meant to vary the framework of drug improvement. His startup Vivodyne has simply raised $40 million to increase its robotic tissue engineering platform, together with a brand new 23,000-square-foot lab in San Francisco, STAT’s Allison DeAngelis studies.
Backed by Khosla Ventures, amongst others, and collaborating with at the very least six unnamed pharma firms, Vivodyne’s tech arrives at a pivotal second — weeks after the FDA and NIH signaled intent to scale back reliance on animal testing.
Former FDA chief: Lack of generics group jeopardizes progress
Latest layoffs on the FDA threaten to undo a cornerstone of the Trump administration’s efforts at enhancing drug affordability: the fast-tracking of generics. In a brand new First Opinion in STAT, former FDA commissioner Scott Gottlieb factors out that the company not too long ago dismissed 13 veteran workers from its Division of Coverage Improvement — consultants who wrote the scientific playbooks that allowed lower-cost variations of refined medication like Ozempic and COPD inhalers to succeed in the market.
“The FDA’s political leaders reconsidered cuts initially made elsewhere throughout the company’s drug packages, even rehiring some key scientists,” he writes. “Nevertheless, the regulatory coverage group within the generic drug group was dismissed wholesale, with no plans to revive this uniquely specialised group.”
Whereas some generics giants can go it alone, most smaller companies depend on this steering to compete, he writes. The transfer, framed as a cost-cutting measure, is short-sighted and will undo years of progress, Gottlieb says.
Extra biopharma trials are occurring solely in China
A world oncology report from IQVIA outlines, by way of most cancers trial stats, how China’s position in biopharma is ever-increasing. There are fewer research being carried out throughout a number of nations, whereas extra are being carried out in China — which might spell a downtick in trial range. In 2015, 37% of trials had been multi-country research, in comparison with simply 20% in 2024. In the meantime, China-specific research rose from round 5% in 2015 to round 40% in 2024. Behold:
