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...
View ArticleHow 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...
View ArticleUpdated: 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....
View ArticleAurion, 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...
View ArticleALK-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...
View ArticleCigna 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
View ArticleAbbVie's schizophrenia drug from Cerevel fails two Phase 2 trials
The centerpiece of AbbVie’s $8.7 billion Cerevel acquisition just imploded. Emraclidine, a schizophrenia program expected to compete with the newly-approved Cobenfy from Bristol Myers Squibb and...
View ArticleAssertio considers legal options against activist investor accusing company...
Assertio Holdings responded to activist investor Alexander Parker after Parker's firm accused Assertio of fraud. The Buxton Helmsley Group on Friday released an open letter to Assertio’s stockholders,...
View ArticleYorvipath’s approval showcases biopharma’s interest in rare endocrine disorder
Michele Rayes used to take 64 pills a day to manage her hypoparathyroidism, a rare endocrine disorder that impairs calcium levels, dampens daily quality of life and can sometimes lead to chronic kidney...
View ArticleThermo Fisher consolidates viral vector work in Massachusetts, cuts 160 workers
Thermo Fisher is closing a factory in Lexington, MA, and merging operations with a newer facility in Plainville, MA, to “optimize” viral vector production, a spokesperson told Endpoints News. The...
View ArticleFDA lifts hold on Novavax vaccines after adverse event reclassified as ALS
The FDA has removed a clinical hold on Novavax’s flu-Covid combination shot and standalone flu vaccine, less than a month after it was first instituted. The vaccine maker
View ArticleRapt cuts immunology program following clinical holds
Rapt Therapeutics is officially shelving its mid-stage immunology candidate after a case of liver failure triggered clinical holds earlier this year. Back in February, the FDA placed holds on two Phase...
View Article23andMe to shut down its therapeutics division
23andMe is closing its therapeutics division and will wind down ongoing clinical trials, the struggling genetic testing company said Monday evening. The company said it’s exploring all strategic...
View ArticleNeurogene's stock falls in post-market trading after early data in Rett syndrome
Neurogene's stock {$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,...
View ArticleGSK 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...
View ArticleNovartis pays $150M upfront to Schrödinger in new drug deal
Novartis will pay $150 million upfront to Schrödinger, in a pact announced Tuesday to work together on several preclinical drug programs. Founded in 1990, Schrödinger has been developing and selling...
View ArticleSanofi, OpenAI, Formation Bio launch Muse, an AI tool for patient recruitment
A flashy collaboration between Sanofi, OpenAI and Formation Bio produced its first AI-powered tool, aiming to speed up the process of recruiting patients into clinical trials. The tool is called Muse...
View ArticleTrace Neuroscience raises $101M for ALS and other neuro conditions
Trace Neuroscience, a startup spun out of Maze Therapeutics' pipeline, broke cover Tuesday morning with $101 million in funding to develop treatments for amyotrophic lateral sclerosis and other...
View ArticleRoche teams with Flare Therapeutics on transcription factors
Roche is aligning with Flare Therapeutics to work on small molecules for cancer by going after transcription factor targets, the companies said Tuesday morning. Cambridge, MA-based Flare has a...
View ArticleAlentis nabs $181M to broaden Claudin's scope in ADCs
Swiss biotech Alentis Therapeutics thinks it can expand the reach of the Claudin family in oncology, and half a dozen new investors are helping back the idea with a $181.4 million Series D. Tuesday's...
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