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Denali teases early data for enzyme replacement therapy in rare disease

Denali revealed new topline data Wednesday for an early-stage program that's a part of the FDA’s Operation Warp Speed for rare diseases. The program, DNL126, is an enzyme replacement therapy for...

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Geron’s royalty deal; Minghui’s new VEGF bispecific data

Plus, news about ADC Therapeutics, Celldex and Viracta Therapeutics: Geron inks up to $375M royalty and debt deal: The company now has a $125 million deal with Royalty Pharma based on ...

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Aurinia cuts nearly half of its workforce in second round of layoffs this year

Aurinia Pharmaceuticals is reducing 45% of its workforce and is bringing in a new board member as part of a broader restructuring. The company announced the layoffs on ...

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Genmab chops early cancer prospects to prioritize Phase 3 projects

Genmab is culling a trio of early oncology assets to focus on upcoming milestones for its late-stage programs that include an ADC from its purchase of ProfoundBio. After “careful consideration,” Genmab...

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Coherus restarts biosimilar supply after delays; Novavax ends Covid vaccine...

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Coherus is resuming the supply of its Neulasta biosimilar after...

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FDA seeks to pull OTC nasal decongestant ingredient due to lack of efficacy

After 17 years of back and forth with citizen petitions and two advisory committees, the FDA on Thursday proposed to pull commonly-used nasal decongestant active ingredients in common over-the-counter...

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Vaccine makers face headwinds from RFK, soft demand and China

Coming out of Covid, the vaccine market appeared to experience a renaissance as the innovations of the pandemic unleashed new products and a new impetus to prevent infections. But just a few years...

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Stephen Squinto's JPM life sciences team is raising a new fund for...

CHICAGO — Stephen Squinto, recruited by JP Morgan a few years ago to head up its Life Sciences Private Capital team, is raising a second fund geared toward more growth-stage opportunities. ...

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Senior AstraZeneca exec detained in China amid wider investigation

The head of AstraZeneca’s operations in China has been detained by authorities there, the company confirmed. Prior to his detainment, Leon Wang, executive vice president of international and president...

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Pfizer to invest $1B in China over next five years — reports

Pfizer is doubling down on its commitment to China as the company continues to face activist pressure around its plans for a new phase of growth. Pfizer China President Jean-Christophe Pointeau said ...

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Athira gives up on lead Alzheimer’s drug, switches tack to ALS

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Nkarta drops another cancer program as it leans into autoimmune disease

Nkarta is punting development of a natural killer cell therapy in cancer to focus instead on the same candidate's prospects in autoimmune disease. The biotech will stop investigating NKX019 in...

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Legend names a president of Carvykti; Novo Nordisk's top North America exec...

Alan Bash is joining Legend Biotech as its president of Carvykti, an unconventional, newly-created role to oversee the commercial future of the biotech's sole marketed cell therapy, among other...

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BenevolentAI co-founder returns with plan to save drug developer

Can Ken Mulvany save BenevolentAI? About a decade ago, Mulvany helped found the company as part of the first generation of AI-focused biotech startups. It soared to a $2 billion valuation, pitching a...

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Daiichi, Alteogen to work on subcutaneous Enhertu; Roche ends Nykode deal

Plus, news about Disc Medicine, AlloVir, Kalaris, Travere Therapeutics and Trevena: Daiichi Sankyo, Alteogen to develop subcutaneous version of Enhertu: Daiichi will pay $20 million upfront to the...

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Charles River to close ‘15 smaller sites’ as demand for early research declines

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Eisai slashes Leqembi sales forecast by almost $100M

Eisai has slashed Leqembi's sales forecast by 25% this year, lowering the ceiling for one of the industry's most closely-watched drugs. The company now expects that the Alzheimer's treatment will bring...

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Amgen and AstraZeneca share positive results in chronic rhinosinusitis

Amgen and AstraZeneca said on Friday that their asthma drug Tezspire reduced nasal congestion and the size of nasal polyps in patients with a different but sometimes related inflammatory condition....

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GSK leaves biotech trade group BIO

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FDA action puts Chinese API manufacturer on import block list

The FDA this week posted an untitled letter sent Oct. 17 to China-based active pharmaceutical ingredient (API) manufacturer Shandong Boyuan Pharmaceutical Co., whose exports to the US have been blocked...

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