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Good morning, we have a lot of news to cover directly this morning.

Califf: ‘We’ll see what happens’ under Trump

At a cancer research conference yesterday, FDA Commissioner Robert Califf said he was “disappointed” with the election results and expressed uncertainty about the agency’s future under the incoming Trump administration.

Given Trump ally Robert F. Kennedy Jr.’s hostility toward civil servants, the agency’s ability to recruit and retain skilled employees could be jeopardized. Trump said he plans to give Kennedy, the leader of the “Make America Healthy Again” movement, authority over health policy in his administration.

“I’m biased, but I think the FDA is at the top of its game right now, and we’ll see what happens when the new team comes in,” Califf said.

Read more From STAT’s Lizzy Lawrence.

BioNTech acquires Chinese cancer drug partner

From my colleague Adam Feuerstein: BioNTech he said today said it bought Chinese drugmaker Biotheus for $800 million to support its cancer strategy.

The two companies were already collaborating on the development of BNT327, an experimental antibody that targets two proteins found in cancer cells, PDL-1 and VEGF. BioNTech had commercial rights to sell BNT237 in the US and Europe. With the acquisition of Biotheus, BioNTech will now also have commercial rights in China.

Other companies, especially Summit Therapiesare developing similar PDL-1/VEGF drugs, all aiming to surpass Merck’s cancer immunotherapy and the world’s best-selling drug, Keytruda.

Circular RNA startup Orna is cutting more jobs

According to information obtained by STAT, biotechnology startup Orna Therapeutics joined financially distressed genetic medicine companies by laying off more people in the second round of layoffs last year.

Launched in 2021, Orna was part of a popular group of companies founded in the wake of the Covid pandemic that planned to create new, more durable types of RNA-based drugs.

It differs from companies such as Moderna and BioNTech in the type of RNA it uses. Instead of the linear strands used in Covid vaccines and mRNA cancer vaccines, Orna uses RNA loops known as circular RNA, which are less broken down by the body.

Read more From STAT’s Allison DeAngelis.

Amgen falls on obesity drug data

On Tuesday, a little yet-to-be-confirmed data on Amgen’s leading obesity candidate wiped $12 billion off its market value.

Cantor Fitzgerald analyst Olivia Brayer found the data in hidden tabs of a file attached to the release of early trial results of the drug MariTide. Brayer said the hidden tabs included results showing that study participants experienced loss of bone mineral density, especially among those in the group taking the highest doses of the drug.

Read more.

J&J sues government over 340B payment terms

Johnson & Johnson has filed a lawsuit against the U.S. Health Resources and Services Administration, alleging that the agency misinterpreted federal law regarding the use of rebates in the 340B Drug Pricing Program, which was created to help hospitals and clinics provide care to low-income and rural patients. .

J&J recently sought to change payment terms for the Xarelto blood thinner and the Stelara plaque psoriasis treatment. But the agency argued that such a move was illegal because it would require hospitals to purchase drugs at prices exceeding those allowed by the rebate program. The agency also insisted that prior approval from the Department of Health and Human Services would be required before such a move could proceed.

The J&J plan sparked opposition from nearly 200 congressional lawmakers, who in late September asked HHS Secretary Xavier Becerra to ensure HRSA tracks payment changes and consider penalizing the company if it overcharges any hospitals.

Read more From STAT’s Ed Silverman.

Further reading

• Its shares are up 50% this year, fueled by billion-dollar deals. How did Boston Scientific get its magic back? Boston Globe
• DOJ sues to block UnitedHealth from acquiring home health giant Amedisys STATISTICS
• With RFK Jr.’s support, unfounded fears about fluoride went mainstream. STATISTICS