March 10, 2026
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National Biotech Reporter

Good morning, I'm not sure how much more disappointment I can handle. We had our second fake spring here in Chicago yesterday, before it's set to potentially snow again this weekend.

The need-to-know this morning

  • Ugur Sahin and Özlem Türeci, co-founders of the Covid vaccine developer BioNTech, are leaving at the end of the year to form their own mRNA-focused company. BioNTech will be giving certain rights to its mRNA technology to the new company, while picking up a minority stake in it. BioNTech also offered a weaker-than-expected revenue forecast for this year, triggering a sell 0ff in its stock price.

biotech

New data keep Vertex in a heated kidney drug race

Vertex said yesterday that an experimental drug drug successfully reduced by half a key marker of an autoimmune kidney disease known as IgA nephropathy.

The Phase 3 results match data from a study of Otsuka’s recently approved Voyxact and are numerically superior to data released last year by Vera Therapeutics.

Vertex said it plans to submit the drug, povetacicept, to the FDA for accelerated approval. Analysts have projected it could eventually bring in $4 billion or more in annual sales.

Read more from STAT's Jason Mast.


infectious disease

Pharma companies are developing fewer antibiotics

The number of antimicrobial drug candidates being developed by large pharma companies plumetted by 35% — from 92 to 60 — over the past five years, according to a new analysis.

The findings highlight a mismatch between business incentives and public health needs.

There's much less incentive for companies to develop antibiotics, which are usually used for short periods of time, than other types of drugs, like treatments for chronic diseases.

But public health officials continue to raise alarms about the dearth of new antibiotics available. Antimicrobial resistance remains one of the most urgent global health threats, causing more than one million deaths annually.

Read more from STAT's Ed Silverman.



glp-1s

Novo gets more marketing firepower from Hims deal

Novo Nordisk and Hims & Hers announced yesterday they've reached a deal that, for now, appears to end their dispute around Hims’ sale of compounded versions of Novo’s obesity drug Wegovy.

Novo is dropping a lawsuit alleging that claims Hims infringed on a patent for its Wegovy products. Meanwhile, Hims agreed to no longer advertise compounded GLP-1 products and will instead offer brand-name Wegovy on its website at cash prices, similar to other telehealth companies Novo partners with.

The deal is a big win for Novo's marketing efforts.

Technically, any patient, regardless of whether they use one of Novo’s telehealth partners, can buy Wegovy at cash prices, but telehealth partnerships allow Novo’s products to be advertised on more sites and get in front of more patients.

“We are hoping that Hims’ patients and then the way that they attract their own patients will lead into, of course, increased volume for our authentic products,” Novo CEO Mike Doustdar told me yesterday.

Experts have raised concerns that these tie-ups between pharma and telehealth companies will lead to overprescription of drugs from the drugmakers.

It's yet to be seen, though, how patients using Hims — one the most prominent firms in the compounding world — will actually start taking brand-name Wegovy. 

The telehealth company said its existing patients will have the opportunity to transition to brand-name medicines “when determined clinically appropriate by their providers.” It will also continue to offer compounded GLP-1s “if a provider determines that a compounded product is clinically necessary.”

Novo said it reserves the right to refile its lawsuit in the future.


manufacturing

Catalent factory issues afflict another biotech

Incyte said the FDA rejected its medicine Zynyz as a treatment for metastatic non-small cell lung cancer due to issues with an Indiana manufacturing site operated by Catalent, which is owned by Novo Nordisk.

This is at least the third company that's gotten a rejection due to issues at the site, after Scholar Rock and Regeneron.

Incyte said the FDA rejection letter cited the regulatory compliance of the Catalent site as “the sole approvability issue,” and did not cite other any other concerns, including the drug's efficacy and safey data, according to a recent SEC filing.

Novo took over the plant in 2024 as part of its parent company's acquisition of Catalent. There have long been issues at the site preceding the deal — inspectors have noted extensive problems around cat hair, pests, bacteria, and equipment failures.


More around STAT
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More reads

  • FDA plans to loosen testing rules to boost biosimilar drugs, Bloomberg
  • Ipsen pulls cancer drug from market over safety risks, Endpoints
  • Opinion: The Himsification of medicine, STAT

Thanks for reading! Until next time,


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