March 4, 2025

The need-to-know this morning

The FDA granted priority review to an application from Capricor Therapeutics for a cell therapy designed to improve heart function in people with Duchenne muscular dystrophy. The agency's approval decision will come on or before Aug. 31.
In retaliation for tariffs imposed by President Trump, China's Ministry of Commerce has banned Illumina from selling its gene-sequencing machines in China.
Sofinnova Partners, a European venture capital firm, raised $1.26 billion for new life-science investments.

fda

Makary pledges to avoid conflicts if confirmed

Marty Makary, President Trump's nominee for FDA commissioner, has pledged to divest stock holdings and resign from advisory roles in various health tech, pharmaceutical, and medical device companies if confirmed, STAT's Lizzy Lawrence reports. That includes Global Appropriateness Measures, a consulting group that uses algorithms to identify unnecessary medical care. He owns $5 million to $25 million in stock for that company alone, according to newly released disclosures.

The Johns Hopkins pancreatic surgeon and former Fox News contributor has been a vocal critic of medical errors and excessive care — and has deviated from mainstream public health experts by criticizing vaccine and mask mandates. That said, the industry has been generally positive about his nomination. It's highly likely he will be confirmed.

nih

Jay Bhattacharya: Scientist, contrarian, NIH nominee

Stanford University health economist and vocal Covid-19 contrarian Jay Bhattacharya is President Trump's choice to lead the NIH, which is drawing both praise and deep concern. While some view him as a champion of scientific inquiry and reform, others see a pattern of political opportunism — as well as retaliation against opponents — and a penchant for basing judgment on selective evidence, STAT's Eric Boodman writes.

His controversial Covid stances have made him a right-wing favorite, but he's alienated much of the scientific community.

"I do think Jay is a reasonable person, not a ideologue," one Stanford professor told STAT. "If there's anyone I wanted to be making the case to the president about the value of science to solve problems and contribute to economic prosperity, it would be Jay Bhattacharya."

dna testing

Wojcicki's controversial bid to reclaim 23andMe

23andMe CEO Anne Wojcicki is attempting to buy her company back for a mere $42 million. It's a fraction of the company's former value: Just four years ago, the DNA testing company was worth $6 billion. The company's plunge follows market shifts, a major data breach, and an expensive foray into drug development.

Wojcicki had tapped the venture firm New Mountain Capital to potentially buy out shareholders at $2.53 a share, valuing the company at $74.7 million, Fortune writes. But according to an SEC filing, the firm backed out of the deal and Wojcicki is trying to buy the company herself.

Wojcicki, who controls 49% of voting power and appointed a new board after the prior one resigned en masse, faces scrutiny over conflicts of interest. 23andMe's vast genomic database retains value, but investors question how fair the deal is, and lawsuits are likely if it proceeds.

Regulation

Drug approval fees and potential bias in Canada

After Canada's Drug Agency mandated in 2014 that pharma companies pay application fees, the likelihood that non-cancer drugs were recommended for government funding increased sixfold, a new study shows. The fees covered 43% of the agency's operating expenses, but also invite debates echoing those that play out in the U.S., where FDA user fees contribute nearly half of the agency's budget.

The findings suggested the fees led to agency bias and raise questions about whether coverage of many of the medicines should be paid for by the different government agencies, the study author told STAT's Ed Silverman.