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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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How Trump, RFK Jr. could influence biopharma; Viking presents weight loss...

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...

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FDA approves Autolus’ CAR-T cell therapy for aggressive blood cancer

US regulators gave the green light to Autolus Therapeutics’ cell therapy for adult B-cell precursor acute lymphoblastic leukemia, or B-ALL, that has returned or is not responding to prior treatment....

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Aurion, Alcon enter legal battle over IPO plan

The eye giant Alcon has launched an unlikely legal battle, suing a cell therapy startup that it invested in and claiming its shareholder rights are being violated as Aurion Biotech prepares to go...

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ALK-Abelló licenses ARS’ anaphylaxis nasal spray in certain markets for $145M

A Danish company is spending $145 million upfront for certain rights to the first-ever needle-free adrenaline nasal spray for severe allergic reactions, unlocking sales potential of more than $400...

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Cigna says it will not pursue a merger with Humana

Cigna said it will not pursue a merger with rival Humana after reports last month of renewed talks about a potential deal. Talks of a deal

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AbbVie's schizophrenia drug from Cerevel fails two Phase 2 trials

The centerpiece of AbbVie’s $8.7 billion Cerevel acquisition just imploded. Emraclidine, a schizophrenia program expected to compete with the newly-approved Cobenfy from Bristol Myers Squibb and...

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Assertio considers legal options against activist investor accusing company...

Assertio Holdings responded to activist investor Alexander Parker after Parker's firm accused Assertio of fraud. The Buxton Helmsley Group on Friday released an open letter to Assertio’s stockholders,...

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Yorvipath’s approval showcases biopharma’s interest in rare endocrine disorder

Michele Rayes used to take 64 pills a day to manage her hypoparathyroidism, a rare endocrine disorder that impairs calcium levels, dampens daily quality of life and can sometimes lead to chronic kidney...

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Thermo Fisher consolidates viral vector work in Massachusetts, cuts 160 workers 

Thermo Fisher is closing a factory in Lexington, MA, and merging operations with a newer facility in Plainville, MA, to “optimize” viral vector production, a spokesperson told Endpoints News. The...

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FDA lifts hold on Novavax vaccines after adverse event reclassified as ALS

The FDA has removed a clinical hold on Novavax’s flu-Covid combination shot and standalone flu vaccine, less than a month after it was first instituted. The vaccine maker

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Rapt cuts immunology program following clinical holds

Rapt Therapeutics is officially shelving its mid-stage immunology candidate after a case of liver failure triggered clinical holds earlier this year. Back in February, the FDA placed holds on two Phase...

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23andMe to shut down its therapeutics division

23andMe is closing its therapeutics division and will wind down ongoing clinical trials, the struggling genetic testing company said Monday evening. The company said it’s exploring all strategic...

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Neurogene's stock falls in post-market trading after early data in Rett syndrome

Neurogene's stock {$NGNE} fell 35% in post-market trading on Monday after a Rett syndrome patient who received a high dose of the company's gene therapy experienced a serious adverse event,...

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GSK acquires Parkinson's small molecule from Vesalius

GSK has licensed a small molecule for Parkinson's and is teaming up on additional targets for the disease and another undisclosed neurodegenerative condition with Flagship-founded Vesalius...

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