23andMe’s Anne Wojcicki, Illumina, Capricor

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Morning. As we speak, we speak in regards to the possible affirmation of FDA nominee Marty Makary, go in-depth on NIH nominee Jay Bhattacharya, and see how a lot 23andMe CEO Anne Wojcicki is prepared to pay for her personal firm. 

The necessity-to-know this morning 

  • The FDA granted precedence evaluate to an software from Capricor Therapeutics for a cell remedy designed to enhance coronary heart perform in folks with Duchenne muscular dystrophy. The company’s approval choice will come on or earlier than Aug. 31. 
  • In retaliation for tariffs imposed by President Trump, China’s Ministry of Commerce has banned Illumina from promoting its gene-sequencing machines in China. 
  • Sofinnova Companions, a European enterprise capital agency, raised $1.26 billion for brand spanking new life-science investments. 

Makary pledges to keep away from conflicts if confirmed

Marty Makary, President Trump’s nominee for FDA commissioner, has pledged to divest inventory holdings and resign from advisory roles in varied well being tech, pharmaceutical, and medical gadget corporations if confirmed, STAT’s Lizzy Lawrence reviews. That features International Appropriateness Measures, a consulting group that makes use of algorithms to establish pointless medical care. He owns $5 million to $25 million in inventory for that firm alone, in response to newly launched disclosures.

The Johns Hopkins pancreatic surgeon and former Fox Information contributor has been a vocal critic of medical errors and extreme care — and has deviated from mainstream public well being consultants by criticizing vaccine and masks mandates. That stated, the business has been usually constructive about his nomination. It’s extremely possible he will likely be confirmed.

Learn extra.

Jay Bhattacharya: Scientist, contrarian, NIH nominee

Stanford College well being economist and vocal Covid-19 contrarian Jay Bhattacharya is President Trump’s alternative to steer the NIH, which is drawing each reward and deep concern. Whereas some view him as a champion of scientific inquiry and reform, others see a sample of political opportunism — in addition to retaliation towards opponents — and a penchant for basing judgment on selective proof, STAT’s Eric Boodman writes.

His controversial Covid stances have made him a right-wing favourite, however he’s alienated a lot of the scientific group.

“I do suppose Jay is an inexpensive particular person, not a ideologue,” one Stanford professor instructed STAT. “If there’s anybody I needed to be making the case to the president in regards to the worth of science to resolve issues and contribute to financial prosperity, it might be Jay Bhattacharya.”

Learn extra.

Wojcicki’s controversial bid to reclaim 23andMe

23andMe CEO Anne Wojcicki is making an attempt to purchase her firm again for a mere $42 million. It’s a fraction of the corporate’s former worth: Simply 4 years in the past, the DNA testing firm was price $6 billion. The corporate’s plunge follows market shifts, a serious information breach, and an costly foray into drug growth.

Wojcicki had tapped the enterprise agency New Mountain Capital to probably purchase out shareholders at $2.53 a share, valuing the corporate at $74.7 million, Fortune writes. However in response to an SEC submitting, the agency backed out of the deal and Wojcicki is attempting to purchase the corporate herself.

Wojcicki, who controls 49% of voting energy and appointed a brand new board after the prior one resigned en masse, faces scrutiny over conflicts of curiosity. 23andMe’s huge genomic database retains worth, however buyers query how truthful the deal is, and lawsuits are possible if it proceeds.

Drug approval charges and potential bias in Canada

After Canada’s Drug Company mandated in 2014 that pharma corporations pay software charges, the probability that non-cancer medicine had been advisable for presidency funding elevated sixfold, a brand new research reveals. The charges lined 43% of the company’s working bills, but additionally invite debates echoing people who play out within the U.S., the place FDA consumer charges contribute almost half of the company’s finances.

The findings advised the charges led to company bias and lift questions on whether or not protection of most of the medicines needs to be paid for by the completely different authorities companies, the research creator instructed STAT’s Ed Silverman.

Learn extra.

Extra reads

  • U.S. well being company now says staff should reply to DOGE e mail, Reuters
  • AstraZeneca, Daiichi unblind Enhertu research early as star ADC helps abdomen most cancers sufferers reside longer, FiercePharma



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