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Thermo Fisher predicts revenue uptick in 2025 as it expects headwinds to ease 

Thermo Fisher told investors it is ready to shut the door on 2024, anticipating biotech funding to improve and lingering business insecurity caused by the Covid-19 pandemic to dissipate in 2025....

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Obesity drug manufacturing deal shouldn't close, Roche CEO says

Antitrust regulators shouldn’t clear Novo Holdings’ planned acquisition of Catalent, Roche CEO Thomas Schinecker said Wednesday, adding to the pressure that industry competitors appear to be trying to...

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Novo Nordisk asks FDA to prohibit semaglutide compounding, following Eli Lilly

Novo Nordisk has asked the FDA to prohibit the compounding of semaglutide, ramping up the company’s fight against pharmacies distributing their own versions of the blockbuster weight loss and diabetes...

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FDA approves Pfizer's RSV vaccine for higher-risk adults

Americans as young as 18 with a chronic condition can now receive an RSV vaccine after Pfizer snagged expanded FDA approval this week. The shot, Abrysvo, is now approved for people 18 to 59 who are at...

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Adults 50 and up should get pneumococcal vaccine, CDC advisors say

More people are now advised to get a pneumococcal vaccine if they haven’t already, as CDC advisors recommended the shots for adults 50 and older who either haven’t gotten one or don’t remember if they...

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Exclusive: Moldova clears first gene editing study for HBV in humans

Precision Biosciences has received clearance from regulators in the Eastern European country of Moldova to begin a human trial of a gene editor for chronic hepatitis B, marking the first such test in...

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GSK offers glimpse at RSV vaccine in at-risk younger adults before ACIP meeting

GSK is presenting its case for broader use of its RSV vaccine with new data from a pair of studies in younger adults with underlying medical conditions and who are immunocompromised. The data come as...

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Novo Nordisk petitions FDA to stop semaglutide compounding over safety risks

Novo Nordisk is continuing its crusade against compounded versions of its blockbuster weight loss drugs by petitioning the FDA to stop allowing such widespread manufacturing and use of a drug that’s...

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Exclusive: University of Toronto spinout raises $53.5M to create new obesity...

A fusion of this year’s buzziest biotech trends — artificial intelligence and obesity drugs — is the focus of a new startup backed with $53.5 million from biotech investors Versant Ventures and DCVC...

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CRISPR therapy cuts hereditary angioedema by 81% in Phase 2 study

The promise of a one-and-done CRISPR infusion is beginning to look more real than ever. On Thursday, Intellia Therapeutics announced that an experimental gene editing therapy reduced dangerous and...

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Facing lost rebates, MGM Resorts to stop covering GLP-1 weight loss shots

LAS VEGAS — MGM Resorts plans to stop covering GLP-1 weight loss shots for its employees next year, after it faced constraints in what it could do to manage soaring costs without losing crucial drug...

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Bayer, Dewpoint to work on heart drug; Viking’s obesity manufacturing plans

Plus, news about Interius BioTherapeutics, Hope Medicine, PMV Pharmaceuticals, Epitopea, Alyssum Therapeutics and a new dementia trial accelerator in the UK: Bayer exercises option to develop heart...

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Zai Lab unveils early lung cancer data as it looks to challenge Amgen's...

Zai Lab released Phase 1a data Thursday morning as it attempts to compete with a recently approved Amgen drug. The program, known as ZL-1310, induced a 74% response rate among 19 patients with...

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Marinus plans another round of layoffs, cost cuts following Phase 3 fail

Marinus Pharmaceuticals is reducing its workforce again and taking other measures to reduce costs after its epilepsy treatment failed a late-stage trial. The TrustTSC trial investigating oral...

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Roche returns to Dyno for its AAV tech with $50M upfront

Roche has inked a new deal with Dyno Therapeutics to develop next-generation AAV capsids for gene therapies targeting neurological diseases, expanding the scope of an existing partnership that started...

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Lonza extends contract with unnamed pharma; Rentschler's new build

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Lonza said it has extended a contract to produce monoclonal...

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Icon's quarterly earnings hit by biotech and pharma pullback

Cost and research cuts across biotech and pharma are affecting some of the contracting companies that rely on the industry. Steve Cutler The latest victim is Icon, a Dublin-based contract research...

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BridgeBio shares promising results in trial of Canavan disease gene therapy

BridgeBio disclosed results Thursday from a Phase 1/2 study of its gene therapy for Canavan disease, an extremely rare and devastating genetic disorder that causes the brain’s white matter to break...

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CDC advisors decline to recommend RSV shots to younger at-risk adults,...

The CDC’s vaccine policy advisors haven’t budged on new RSV guidance, remaining unconvinced that younger adults at higher risk of disease should get the shot. That was the takeaway from a presentation...

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Sanofi backs fibrosis biotech Agomab as it raises $89M Series D

Agomab Therapeutics is benefiting from Sanofi’s push to become an immunology powerhouse. The Antwerp-based biotech said Friday that the French drug giant and Invus are new investors in its $89 million...

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