STAT News – Biotech
STAT+: Pharmalittle: We’re reading about Novo Nordisk boosting consumer focus, FDA approving a gene therapy, and more
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, although we do plan to attack our to-do list of chores and errands, promenade with the official mascots, and escort Mrs. Pharmalot to a soiree. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? Now that spring has sprung, there is opportunity to explore the great outdoors. Depending on your mood, you could hike a trail, stroll a city street, or, our favorite activity, take a long drive to nowhere. For those of you who prefer to stay home, there is always a good book or a flick on the telly. The possibilities are endless. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
Novo Nordisk appointed Poul Weihrauch, who is chief executive officer of the Mars candy company, as board observer amid a move by the drug maker to strengthen its position in the highly competitive U.S. obesity market, Reuters points out. Novo Nordisk and its majority shareholder, the Novo Nordisk Foundation, carried out a leadership shake-up last year, replacing the chief executive officer and restructuring the board. This included the consolidation of Lars Rebien Sorensen’s leadership role through his appointment as board chair in addition to his role as chair of the foundation. Sorensen has promised to strengthen the board’s pharmaceutical and commercial expertise after criticizing the previous board for being slow to address U.S. market challenges. Novo is trying to boost consumer credentials in the U.S. market in a number of ways under its new management. In January, it launched its Wegovy pill across multiple cash-pay channels, rather than solely through traditional insurance routes.
The U.S. Food and Drug Administration approved a gene therapy for severe leukocyte adhesion deficiency type 1 (LAD-1), an ultra-rare disease that leaves children vulnerable to life-threatening infections, STAT notes. The therapy, marketed as Kresladi, was developed by Rocket Pharma and was initially rejected by the agency in 2024 over manufacturing concerns. Recently, though, the FDA has indicated its willingness to relax some of its manufacturing requirements to ease such therapies along. Rocket is likely to charge millions of dollars for the one-time treatment, but Kresladi is not expected to be a major money maker. LAD-1 is thought to affect only around 1 in a million people, with Rocket estimating around 25 new cases per year. The approval, however, will earn the company an FDA priority review voucher that can be used to have another drug approved in just six months, rather than the typical 10.
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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