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Look out next week for our annual Women in Biopharma R&D report celebrating 20 exceptional researchers, entrepreneurs, data experts and more. We’ll kick off a related event on Tuesday at 11 am ET with a fireside chat with Marsha Henderson, the FDA’s former associate commissioner for women’s health, followed by a panel with two of this year’s honorees. You can register here.
WuXi companies consider selling units impacted by Biosecure — report
WuXi AppTec and WuXi Biologics are looking to sell part of their operations that have struggled because of the Biosecure Act, the Financial Times reported. WuXi AppTec said in a statement that it’s “assessing options for continuing WuXi Advanced Therapies’ operations in line with our priorities.” Endpoints News’ Jared Whitlock has the latest.
Eli Lilly resolves tirzepatide shortage
In other manufacturing news, the FDA confirmed on Wednesday that the shortage for Eli Lilly’s blockbuster weight loss and diabetes drug tirzepatide is resolved and Lilly can officially meet present demand. That may create confusion for patients relying on cheaper compounded versions, which are permitted in certain circumstances when a drug is in short supply.
J&J, Bayer trim New Jersey staff
Both Johnson & Johnson and Bayer revealed plans to lay off workers in New Jersey this week, with the moves expected to come before the end of December. J&J will lay off 231 employees while Bayer will lay off 57. Neither elaborated on which units would be affected, but Bayer’s comes amidst a broader, conglomerate-wide reorganization.
Ron Renaud’s latest biotech
Obesity biotechs continue to attract significant financing rounds, and longtime entrepreneur Ron Renaud is behind the latest company, Kailera Therapeutics. The company pulled in $400 million and partnered with Jiangsu Hengrui Pharmaceuticals on four programs. CEO Renaud expects a global Phase 3 to start “as quickly” as it can.
Roche bets on Regor drugs
In what analysts described as a “sensible bolt-on,” Roche spent $850 million in upfront cash to acquire two experimental CDK inhibitors from Regor Pharmaceuticals. The drugs are designed to treat breast and brain cancer, respectively. Roche will take over development after both programs advance through Phase 1 studies.
Prime cuts pipeline, partners with BMS
Gene editing companies have faced cutbacks this year, and now David Liu’s Prime Medicine is joining the fray. The startup, focused on “CRISPR 3.0” prime editing, slashed its pipeline down to five programs after previously boasting as many as 18. But Prime also signed a partnership with Bristol Myers Squibb, getting $55 million in cash, $55 million in equity, and up to $3.5 billion in promised milestones.
SPOTLIGHT
- Exclusive: After discovering antibiotics with AI, a 31-year-old first-time CEO raises $17M to fight aging
- Lilly invests $4.5B in new Indiana site to bring clinical manufacturing in-house
R&D
- Roche partner Poseida Therapeutics released another Phase 1 update for its off-the-shelf CAR-T this week. The incremental data build on a readout from ASH last year.
- BioNTech held its first artificial intelligence summit, unveiling a new AI model for designing antibodies from scratch.
- J&J discontinues mid-stage dengue study, citing deprioritization of communicable disease work
- Exclusive: Relay Therapeutics cuts another 10% of company, citing continued streamlining efforts
- IGM scraps oncology work to focus on autoimmune, loses three executives
- Shattuck Labs cuts CD47 program and 40% of workforce as it focuses on IBD drug
PHARMA
- California Gov. Gavin Newsom vetoed bipartisan legislation that would have reformed pharmacy benefit managers in the state, prompting the bill’s author to call the decision “a massive fail.”
- 23andMe CEO says she is no longer open to outside takeover offers
- GSK’s ViiV stops development of Phase 2 HIV antiviral
- Federal judge dismisses longstanding suit over Bristol Myers’ $74B Celgene buyout
FINANCING
- Biotech’s third quarter was relatively bright. The third quarter was up and down, with the Yen carry trade fiasco and the typical August lull. But then came a long-awaited interest rate cut, and a mini IPO revival began.
- Lilly-partnered radiopharma startup Aktis Oncology raises $175M
- Flagship partners with key Singapore R&D agency as it boosts APAC investment
- Investor Kurma Partners raises €140M for latest Europe-focused biotech fund
- UK biotech bags $43M in Series A to move Huntington’s drug into first human study
- Triveni to take experimental eczema drug to the clinic, backed by new $115M financing round
DEALS
- Obesity startup Metsera teamed up with Amneal to manufacture its metabolic disease drugs, and Clive Meanwell stepped down as CEO.
- CAMP4, preparing for IPO, announces partnership with BioMarin
FDA+
- Johnson & Johnson called off plans to implement a new rebate model for 340B drug price discounts following threats from the federal government. Under the plan, some hospitals serving low-income patients would no longer receive upfront discounts on its drugs Xarelto and Stelara.
- FDA pledges to take next steps on advisory committee changes
- EMA reviews hair loss products following concerns about suicidal thoughts
- Opdivo gets FDA approval for use around lung cancer surgery, following Keytruda and Imfinzi
MANUFACTURING
- Novo Nordisk and Eli Lilly have drafted plans to avoid supply disruptions from seaport strikes across the East and Gulf Coasts, the companies confirmed to Endpoints.
- Gilead licenses HIV shot to six generic manufacturers, but falls short of access sought by advocates
- J&J budgets over $2B for new North Carolina biologics facility
HEALTH TECH