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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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Novartis 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...

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Sanofi, 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...

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Trace 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...

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Roche 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...

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Alentis 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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AstraZeneca budgets another $2B to boost manufacturing and R&D in US

Among a flurry of third-quarter updates on Tuesday, AstraZeneca said it is earmarking an additional $2 billion to add 1,000 new jobs in the US. This is on top of the ...

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Bayer not eyeing new deals to address Xarelto sales erosion

Bayer reiterated its plans to ride out the generic-driven sales decline of its thrombosis drug Xarelto, as the company’s shares plummeted to a record low because of lackluster third-quarter earnings....

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AstraZeneca, Daiichi Sankyo replace lung cancer filing for Enhertu successor

AstraZeneca and Daiichi Sankyo are changing the approval submission strategy for its planned Enhertu successor, datopotamab deruxtecan (Dato-DXd), after a few missed trials. The companies voluntarily...

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Exclusive: GV-backed Medicaid startup Diverge Health raises $52M

A startup that helps low-income Medicaid members get the care they need and supports the doctors who work with them has raised $52 million, it confirmed to Endpoints News. Alphabet's venture arm GV led...

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Apollo makes a deal worth up to $926M; Abeona resubmits gene therapy

Plus, news about Centessa, Autolus Therapeutics, Zucara Therapeutics, Vindur Tx, Vittoria Biotherapeutics and the MD Anderson Cancer Center: Apollo Therapeutics’ cardio-metabolic pact: The company will...

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Merck KGaA plans China submission after late-stage win for tumor drug

Merck KGaA’s experimental treatment for patients with tenosynovial giant cell tumors hit the primary endpoint in a Phase 3 study, and the company plans to submit the drug for approval in China with its...

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FDA commissioner warns of risk to agency under RFK Jr. influence

With just a few months to go before he likely steps down, President Biden's FDA Commissioner Rob Califf weighed in on how the agency might be affected by the incoming administration. Califf, while not...

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FDA denies Ocaliva full approval, but Intercept hopes to keep drug on market

The FDA rejected the full approval submission for Intercept Pharmaceuticals and Alfasigma’s primary biliary cholangitis treatment Ocaliva after safety concerns dogged the product, casting its future...

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Merck, AstraZeneca tout Phase 3 win for Koselugo in neurofibromatosis

Merck and AstraZeneca are hoping to expand the label of their MEK inhibitor Koselugo to certain adult patients with neurofibromatosis type 1 following a successful Phase 3 study. The companies

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