STAT News – Biotech
STAT+: Political influence ‘a serious problem’ for FDA under Trump, former commissioner says
Hundreds of individualized treatments for rare diseases could become available over the next decade — but only if government regulators handle the new therapeutics properly.
At least that’s how Robert Califf, former commissioner of the Food and Drug Administration, sees it, he said at STAT’s Breakthrough Summit East on Thursday. New bespoke gene therapies, which may only treat a small number of patients, could hold great promise in the aggregate, he suggested, if the agency can properly assess them.
“But if we don’t get this right, we could end up in a dead end that sets things back by a number of years,” he said.
STAT News – Biotech
STAT+: Amid focus on food, FDA leader briefs lawmakers on priorities
WASHINGTON — Food and Drug Administration officials briefed senators on the agency’s plans for food policy for 2026, according to a person familiar with the meeting.
The agency plans to focus on infant formula safety, updating food labels, defining ultra-processed foods, expanding inspections of food processing plants, and bolstering seafood safety programs, according to a document shared with lawmakers, obtained by STAT.
The meeting comes amid a shift in the administration’s health agenda toward food issues and away from vaccine policy. In recent polls, food reforms have been more popular than the vaccine agenda, catching the attention of administration officials looking to sharpen their message for the midterms.
STAT News – Biotech
STAT+: In private meetings, White House works to win pharma companies’ support for drug pricing bill
WASHINGTON — The White House has drafted legislative text for its drug pricing policy, and officials are in the process of sharing it with more than a dozen major pharmaceutical companies, according to people familiar with the meetings.
The legislative text, according to a White House official, closely follows the outlines of the voluntary deals the administration made with pharma companies. The draft includes a policy that would allow drugs purchased in cash to count toward a patient’s deductible.
The Trump administration’s push for drug price legislation is part of a larger effort to get health reforms signed into law. The president’s focus on his affordability agenda in an election year has heightened the profile of the effort.
STAT News – Biotech
STAT+: China’s biotech boom is rewriting everything
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The NIH’s foreign subaward crackdown is scrambling global collaborations, while China’s rapid ascent is reshaping drug development. Meanwhile, Wave Life Sciences sheds half its value on underwhelming obesity results.
Also, breaking: I’m adopting a rogue backyard tortoise and will name it Philbert.
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