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A MAHA makeover, and new leaders for the FDA and NIH

March 26, 2025
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National Biotech Reporter
Good morning. The MAHA movement is influencing not only the federal government, but also state legislatures across the U.S. We discuss all that and the key biotech news today.

The need-to-know this morning

  • An RNA-based drug from Wave Life Sciences increased the production of dystrophin and improved muscle function in 11 patients with Duchenne muscular dystrophy caused by an exon 53 mutation, according to updated Phase 2 study results. Wave anticipates seeking accelerated approval for the drug, called WVE-N531, in 2026. 

politics

State legislatures are getting a MAHA makeover 

HHS Secretary Robert F. Kennedy Jr.'s Make American Healthy Again movement is quickly prompting lawmakers in conservative states like Texas, Florida, Oklahoma, and Utah to introduce bills aimed at tackling health issues.

Some measures, like ones that ban artificial dyes and preservatives, align with nonpartisan issues concerning the safety of the U.S. food supply. But other bills are more specific to the MAHA movement, such as efforts to ban fluoride from drinking water, restrict the use of mRNA, and make ivermectin available over the counter.

The wave of legislation shows that with MAHA as an accelerant, states are attempting to exert influence over national policy and corporate practices that affect health.

Read more from STAT's Sarah Todd and Isa Cueto.



politics

Trump's picks to lead FDA and NIH are confirmed

The Senate yesterday voted largely along party lines to confirm Marty Makary as FDA commissioner and Jay Bhattacharya as NIH director.

Both are assuming leadership of agencies that have been pummeled by workforce cuts and are lagging in morale. Particularly at the FDA, hundreds of probationary employees were laid off in February, only for many to be rehired a week later. A punishing return-to-work order is also making some employees miserable. Read more from STAT's Lizzy Lawrence.

Elsewhere, the Senate Finance Committee yesterday voted along party lines to move forward the nomination of Mehmet Oz to be CMS administrator to the full Senate floor, bringing him closer to leading the agency that oversees health care for about 160 million Americans. Read more from STAT's Tara Bannow.


Artificial intelligence

Altis says its AI tool can cut risk in cancer trials

Altis Labs, a Canadian health care company, said that its AI tool outperformed the conventional method of predicting overall survival when analyzing scans from a group of lung cancer patients.

The company said that its tool is also superior at analyzing breast cancer and colorectal cancer scans, potentially offering drugmakers a better way to design their clinical trials.

The idea is that, with Altis' tool, drugmakers would be able to better understand patients' risk profiles and better randomize their trial participants.

Read more from STAT's Brittany Trang.


drug pricing

Net prices rose modestly while list prices grew more slowly 

The net prices that health plans paid for medicines (the prices they pay after rebates, discounts, and fees) rose a modest 0.4% in last year's fourth quarter, but that compared unfavorably with a 3% decline in the same period a year earlier, according to the latest data from research firm SSR Health.

This was driven by the net prices of certain oncology medicines that Medicare covers. 

Tugging in the other direction, though, was AbbVie's blockbuster autoimmune treatment Humira. The growing number of Humira biosimilars on the market has stifled a further rise in net prices.

Meanwhile, list prices for all drugs grew 1.4% in the first quarter of the year, slower than 5.4% growth a year earlier. Most of this was traced to the move by  major insulin makers (Eli Lilly, Novo Nordisk, and Sanofi) to lower list prices.

Read more from STAT's Ed Silverman.


More around STAT
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More reads

  • Lyndra Therapeutics to wind down amid funding hurdles for long-acting drug technology, Endpoints
  • The Trump administration wants more studies replicated. That won't be easy, Axios
  • Opinion: Dismantling the CDC's Division of HIV Prevention will cost far more than it saves, STAT

Thanks for reading! Until tomorrow,


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