STAT News – Biotech
STAT+: Pfizer’s Lyme vaccine results set up tricky regulatory path
Pfizer and Valneva’s Lyme disease vaccine cut cases by about 73% in a Phase 3 trial, but missed its primary statistical endpoint — setting up a tricky regulatory path despite strong efficacy and safety signals.
Meanwhile, a new Parkinson’s startup is betting on personalized neuron replacement, Insmed moves to expand Arikayce earlier in disease, Apogee touts a longer-lasting eczema drug, and geopolitical tensions begin to strain drug supply chains.
Pfizer’s Lyme data has an awkward statistical miss
Pfizer and Valneva’s Lyme disease vaccine looks meaningfully effective, cutting cases by about 73% in a large Phase 3 trial. But the inoculation failed its primary endpoint: The confidence interval came in below the pre-specified threshold, a miss that could complicate regulatory review despite the overall data and safety profile looking solid, STAT’s Matthew Herper writes.
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.
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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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