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Good morning, lots of news this morning that we’ll get straight into.
Califf: ‘We’ll see what happens’ under Trump
At a cancer research conference yesterday, FDA Commissioner Robert Califf said he’s “disappointed” about the election’s outcome and suggested he’s unsure about the future of the agency under the incoming Trump administration.
The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s hostility to civil servants. Trump has said he plans to give Kennedy, leader of the “Make America Healthy Again” movement, power over health care policy in his administration.
“I’m biased, but I feel like the FDA is at peak performance right now and we’ll just see what happens as the new team comes in,” Califf said.
Read more from STAT’s Lizzy Lawrence.
BioNTech acquires its Chinese cancer drug partner
From my colleague Adam Feuerstein: BioNTech said today that it is acquiring the Chinese drugmaker Biotheus for $800 million to bolster its cancer strategy.
The two companies were already collaborating on the development of BNT327, an experimental antibody that targets two proteins, PDL-1 and VEGF, found on cancer cells. BioNTech owned commercial rights to sell BNT237 in the U.S. and Europe. With the acquisition of Biotheus, BioNTech will now also own commercial rights to China.
Other companies, most notably Summit Therapeutics, are developing similar PDL-1/VEGF drugs, all of which aim to surpass Keytruda, the cancer immunotherapy from Merck and the world’s top-selling medicine.
Circular RNA startup Orna cuts more jobs
Biotech startup Orna Therapeutics cut more jobs in its second round of layoffs in the last year, STAT has learned, joining a line of genetic medicines companies struggling financially.
Orna, launched in 2021, was part of a buzzy cohort of companies established in the wake of the Covid pandemic, planning to create new, more durable types of RNA-based medicines.
It differs from companies like Moderna and BioNTech in the type of RNA it uses. Rather than the linear strands that were used in Covid vaccines and mRNA cancer vaccines, Orna uses what’s known as circular RNA — loops of RNA that are less easily degraded by the body.
Read more from STAT’s Allison DeAngelis.
Amgen plummets on scrap of obesity drug data
On Tuesday, a tiny shred of data on Amgen’s lead obesity candidate that hasn’t yet been verified erased $12 billion in market value.
Cantor Fitzgerald analyst Olivia Brayer found the data in hidden tabs of a file attached to the publication of early trial results for the drug, MariTide. The hidden tabs contained what appeared to be results showing study participants experiencing loss of bone mineral density, especially among those in the group taking the highest doses of the drug, Brayer said.
STAT could not confirm the veracity of the data, and several observers raised caveats. But a large move in Amgen’s stock based on a single analyst note with ambiguous data is a reminder of how heavily expectations on weight loss drug readouts are weighing on company stocks.
J&J sues government over 340B payment terms
Johnson & Johnson sued the U.S. Health Resources and Services Administration, alleging that the agency has wrongfully interpreted a federal law concerning the use of rebates in the 340B Drug Pricing Program, which was created to help hospitals and clinics care for low-income and rural patients.
J&J recently sought to change payment terms for its Xarelto blood thinner and the Stelara plaque psoriasis treatment. But the agency maintained that such a move is unlawful because it would require the hospitals to purchase the medicines at prices exceeding what the discount program permits. The agency also insisted that prior approval by the Department of Health and Human Services would be required before such a move can proceed.
The J&J plan prompted objections from nearly 200 congressional lawmakers who, in late September, wrote HHS Secretary Xavier Becerra and urged him to ensure that the HRSA would monitor the payment changes and to consider penalizing the company if it overcharged any hospitals.
Read more from STAT’s Ed Silverman.
More reads
- Buoyed by billion-dollar deals, its stock is up 50% this year. How did Boston Scientific get its mojo back?, Boston Globe
- DOJ sues to block UnitedHealth takeover of home health giant Amedisys, STAT
- With a push from RFK Jr., baseless fears about flouride go mainstream, STAT