Trump wins for MAHA, Novo sales, CAR-T safety

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Good morning, the big news this morning, so let’s get straight to the point.

Trump’s victory clears the way for MAHA movement and FDA overhaul

Donald Trump’s election victory marks a new era for the biopharmaceutical industry. In his campaign, he promised to shake up public health agencies, change federal health care programs and cut high costs throughout the system. He also said he was prepared for campaign aides like Robert F. Kennedy Jr. to “go crazy” on health, medicine and food policy.

Trump repeated that promise in his victory speech. “We might add a few names, like Robert F. Kennedy Jr.,” Trump told supporters. “And he’s going to help America get healthy again… He’s a great guy and he really means he wants to do something and we’re going to let him go for it.”

Trump will have a Republican Senate to help implement his agenda and confirm his nominees, as the GOP has won the seats it needs to regain its majority in the Senate. The Associated Press has not yet said which party will control the House of Representatives.

Novo reports strong Wegovy sales, sending shares higher

Here are the highlights from Novo Nordisk’s third-quarter earnings report this morning: Quarterly profit reached DKK 33.8 billion ($4.88 billion), compared with estimates of DKK 33.5 billion, according to consensus data compiled by Visible Alpha. Wegovy’s sales reached 17.3 billion crowns ($2.5 billion), against expectations of 15.8 billion crowns. Overall, the obesity treatment business grew 44%.

That will be seen as a win for Novo, especially after rival Eli Lilly reported earnings that fell below forecasts last week. Novo shares rose further in early trading.

AstraZeneca fails due to reports of Chinese investigation

AstraZeneca shares fell more than 7% yesterday after the publication of the Chinese publication Yicai Global reported that dozens of top managers of the company’s Chinese branch were involved in an insurance fraud case.

This comes after the company said last week that Leon Wang, the president of its Chinese subsidiary, was under investigation by Chinese authorities.

AstraZeneca said in a statement: “As a matter of policy, we do not comment on speculative media reports, including those related to ongoing investigations in China. If necessary, we will fully cooperate with the Chinese authorities. We continue to deliver life-changing medicines to patients in China and our operations continue.”

As STAT Contributor Brian Young reported earlier this weekWang’s investigation raises questions about the company’s tactics in China. There was speculation that this was related to allegations that local employees altered patients’ genetic testing results so that the Chinese medical reimbursement agency would cover the use of the drug Tagrisso to treat cancer.

Arcellx and Gilead Release Promising CAR-T Safety Data

Arcellx and Gilead Sciences’ experimental CAR-T therapy for multiple myeloma resulted in zero cases of late neurotoxicity, including parkinsonian symptoms and cranial nerve palsy, according to early results from a phase 2 clinical trial published yesterday.

The data, although preliminary, suggests the treatment may be a safer option than Karvitky, the currently approved CAR-T drug from Johnson & Johnson and Legend Biotech. According to published clinical trial results, parkinsonian symptoms and cranial nerve palsy were observed in approximately 10% of patients treated with Carvicti.

Read more from STAT’s Adam Feuerstein.

Pharmaceutical portals usher in an era of dystopia

New online portals recently launched by pharmaceutical companies are ethically questionable and usher in a dystopian era in which drug makers essentially sell their drugs directly to patients, two researchers argue in a paper.

Adriana Few-Berman and Judy Butler, researchers at PharmedOut, a Georgetown University research project on inappropriate pharmaceutical marketing practices, note that sites such as Lilly Direct and PfizerForAll encourage patients to seek immediate consultation with a telemedicine prescriber who will recommend a drug. which can then be ordered through these sites.

“Oh, sure, there’s some co-operative doctor involved from a supposedly independent provider of co-operative doctors. But the thin camouflage of a white coat cannot hide the fact that working for a company tied to a pharmaceutical manufacturer and prescribing the same drug to almost everyone is not the practice of medicine,” they write.

Trump’s victory clears the way for MAHA movement and FDA overhaul

Novo reports strong Wegovy sales, sending shares higher

AstraZeneca fails due to reports of Chinese investigation

Arcellx and Gilead Release Promising CAR-T Safety Data

Pharmaceutical portals usher in an era of dystopia

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