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...
View ArticleAdults 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...
View ArticleExclusive: 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...
View ArticleNovo 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...
View ArticleExclusive: 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...
View ArticleCRISPR 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...
View ArticleFacing 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...
View ArticleBayer, 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...
View ArticleZai 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...
View ArticleRoche 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...
View ArticleLonza 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...
View ArticleBridgeBio 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...
View ArticleCDC 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...
View ArticleSanofi 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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Sanofi reports sales jump for Beyfortus as RSV antibody challenger from Merck...
As Sanofi declares strong early sales for Beyfortus in its second RSV season, the French pharma is confident that it would still come out on top against potential competitor Merck because its antibody...
View ArticleGSK to spend $800M to build two vaccine factories in the US
GSK said it is making its largest manufacturing investment in the US yet, allocating $800 million to upgrade its vaccine production site in Pennsylvania. Two new facilities will double the current size...
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Chinook alums reunite following exit to Novartis; The first board appointment...
Tom Frohlich → Tom Frohlich has signed on as CEO of autoimmune disease specialist Jade Biosciences, a company in the Paragon portfolio that raised an $80 million launch round in August. Frohlich...
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