Inflation Reduction Act may be a boon for generics

Generics makers were terribly threatened by the Inflation Reduction Act and lobbied against it. Now it turns out the law could actually boost their sales. The legislation allows Medicare to negotiate prescription drug prices — but it can't bargain for any drug that competes against a marketed generic medicine. That means branded drug makers might better off allowing generics to copy their product.

"Would I rather let the generic come to the market and compete against the generic than go into negotiation with the government?" one health policy consultant said.

cancer vaccines

Oncolytic virus has potential in breast cancer

T-VEC, a virus engineered by Amgen to kill cancer cells, helped improve the overall survival in patients with early-stage triple-negative breast cancer in a phase 2 trial. The oncolytic virus was given during chemotherapy and before surgery, and didn't seem to increase toxicity in the patients. "That's very exciting because this is something that could be used to improve response to immunotherapy without increasing the severity of autoimmune toxicities that women might experience," the study's lead author told STAT.

In the trial, 45.9% of patients had no living cancer cells in the tumor after treatment with chemotherapy and the oncolytic virus. Typically, that's only seen in 15% to 30% of patients with just chemotherapy. That said, the study was small — fewer than 40 patients — and was neither randomized nor controlled.

covid drugs

The mutations coming from molnupiravir

Molnupiravir, made by Merck, has been an underwhelming asset in the anti-Covid armamentarium. It's not particularly effective, and it is seldom used. It may also be a pretty risky drug, opines biologist Derek Lowe in a Science blog.

Molnupiravir works by triggering so many mutations in the virus that it's rendered ineffective. But, as a new preprint suggests, the coronaviruses that evade destruction from molnupiravir's middling attacks seem to end up circulating as a new variant.

Lowe underscores that this has been a consideration since molnupiravir first got emergency use authorization, and that coronaviruses are constantly evolving — so any mutations aided by molnupiravir aren't necessarily more dangerous than those that would occur naturally. "We are indeed seeing molnupiravir-induced mutant strains," Lowe says, "but it's also possible that without it we might be seeing slightly more evolved mutant strains coming from those same patients."

Podcast

Just how alarming is bird flu?

And did we learn enough from Covid-19 to be sensible about it? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast. Helen Branswell, STAT's senior writer covering infectious disease, joins us to explain the sudden resurgence of a bird flu virus called H5N1 and why experts are watching the situation closely.

Listen here.

M&A

Large drug makers on the acquisitive prowl

Biopharma companies like Pfizer, Merck, and Novartis are avidly hunting for new deals, looking to replenish their pipelines as many best-selling drugs begin to lose patent protection in the near future, the Wall Street Journal writes. AbbVie, which had limited itself to deals below $2 billion, has lifted that self-imposed restriction in an effort to acquire more assets.

The dollar value of last year's biopharma deal-making was the lowest since 2017. But by the end of 2022, life sciences had more than $1.4 trillion in cash on hand — and now they're ready to spend. Pfizer, which made a windfall from its Covid vaccines, now has $36 billion in cash and is interested in drugs in early- to mid-stage testing, because companies with late-stage or approved assets don't fit in with its existing pipeline. Novartis is looking for biotech companies valued at $5 billion or lower, which are also in early- to mid-stage development. And Merck's working to diversify in preparation for Keytruda going off patent in 2028. It's on the lookout in the areas of cancer, heart, immune and neurological diseases, as well as vaccines.

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