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Hi! Today we see that prime editing works nicely in monkeys, learn more about the potential new bill to speed treatments for life-threatening diseases, and find that a Regeneron (formerly Decibel) therapy may restore hearing in children.

The need-to-know this morning
• Sanofi said it will spin out its consumer health unit and cut costs in other areas in order to increase spending on research and development of new medicines. Separately, the French pharma giant reported third-quarter earnings and revenue that fell short of analyst consensus. Sanofi reiterated its financial forecast for the remainder of the year, but new, long-range guidance for 2024 and 2025 implies financial results lower than current analyst estimates.
• Abbvie reported adjusted third-quarter earnings of $2.95 per share, beating the consensus estimate. Revenue was $13.93 billion, down 6% year over year but better than consensus. Sales of the arthritis medicine Humira fell 36% from the previous year to $3.5 billion, largely due to generic competition, but were still in line with consensus. The company raised financial guidance for the remainder of the year.
• The FDA approved a new treatment for ulcerative colitis made by Eli Lilly. As Jonathan Wosen reports, the drug, called Omvoh, is the first to target an immune signaling pathway that plays a key role in sustaining the chronic, gastrointestinal disease.

Continue to STAT+ to read the full story…

GSK’s recent launch of a new RSV vaccine for adults is emblematic of this move, adding to a portfolio that includes other vaccines, such as the very successful Shingrix for shingles, as well as drugs for HIV, other infectious diseases, and cancer, among others. But what does the growing sentiment against vaccination, not just in the United States but around the world, mean for such a bet on this market?

“It’s a very, very serious issue,” Walmsley said, noting that in 11 U.S. states, basic vaccination rates are now lower than they were before Covid. “The answer can’t be sort of flinging science over the airwaves and saying ‘trust us,’ because people don’t. There is a really serious challenge of misinformation and the ongoing issue of politicization, which I suspect is going to get more challenging in the next year for obvious reasons.”

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Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.

The organization looked at four blockbuster drugs — Humira, Avastin, Rituxan, and Lantus — that had biosimilars launched between 2019 and 2023. On average, each of the drugs in the analysis earned three times the revenue during the patent extension period as they did during the original patent protection period, which gave them an average 13.2 years of unchallenged market presence.

Overall, the drugs made 56% of their overall revenue in the years after the end of the initial patent. In the first 20 years, they made $126 billion of the total $284 billion they earned up until competitors entered the market.

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MIAMI — Dr. Alfonso Sabater pulled up two photos of Antonio Vento Carvajal’s eyes. One showed cloudy scars covering both eyeballs. The other, taken after months of gene therapy given through eyedrops, revealed no scarring on either eye.

Antonio, who’s been legally blind for much of his 14 years, can see again.

The teen was born with dystrophic epidermolysis bullosa, a rare genetic condition that causes blisters all over his body and in his eyes. But his skin improved when he joined a clinical trial to test the world’s first topical gene therapy. That gave Sabater an idea: What if it could be adapted for Antonio’s eyes?

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The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.

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Almost a year ago, three top investors at Lux Capital and Obvious Ventures announced they were leaving the firms, teasing on Twitter that they were starting “something new.”

That something is a new venture capital firm, which launched Wednesday with $350 million for its first fund.

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But research presented at the American Society of Hematology meeting in New Orleans suggested that a second-generation drug called zanubrutinib from BeiGene is about to unseat ibrutinib as “the king on the block” for the treatment of chronic lymphocytic leukemia, said Catherine Diefenbach, medical director of the lymphoma program at the NYU Langone’s Perlmutter Cancer Center.

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