Viatris' India-based manufacturing site blocked from shipping 11 generic...
Generic drug firm Viatris announced Monday that one of its India-based manufacturing facilities has been placed on import alert by the FDA following receipt of a warning letter for deficiencies cited...
View ArticleDrugmakers sue government over 340B discounts to STD clinics
Amgen, Eli Lilly and UCB sued the federal government, claiming that several STD clinics getting drug discounts under the federal 340B aren't actually eligible. In their joint lawsuit filed Friday, the...
View ArticleCMS explains what went into its first round of drug price negotiations
The Centers for Medicare and Medicaid Services on Friday released detailed but heavily redacted explanations of how it determined new prices for the first 10 drugs negotiated under the Inflation...
View ArticleFederal appeals court says Teva must delist Orange Book inhaler patents
The Federal Trade Commission is praising an appeals court decision calling for Teva to delist five inhaler patents from the FDA’s Orange Book. The case relates to Amneal’s efforts to market a generic...
View ArticleWuXi AppTec sells cell and gene therapy business to investor
WuXi AppTec will sell its Advanced Therapies unit to the US private equity firm Altaris for an undisclosed amount, a long-anticipated move after months of concern that Congress would pass legislation...
View ArticleBioNTech settles with NIH, UPenn in Covid vaccine disputes and will pay...
BioNTech has entered into settlement agreements with the NIH and the University of Pennsylvania, marking a key turning point in the long-running disputes and the inking of royalty payments. The...
View ArticleJ&J partners on STAT6; AstraZeneca, Daiichi withdraw lung cancer drug EMA app
Johnson & Johnson is partnering with the Japanese company Kaken on a STAT6 program. J&J will get the rights to KP-723, an oral STAT6 inhibitor still ...
View ArticleFDA approves subcutaneous version of Bristol Myers' Opdivo
A decade after Bristol Myers Squibb first won approval for its PD-1 checkpoint inhibitor Opdivo, the cancer drug has been approved in a subcutaneous form that's becoming a new area of competition for...
View ArticleDespite mixed data in Alzheimer's agitation, Axsome will still seek FDA approval
Axsome Therapeutics on Monday reported data for two Phase 3 studies in Alzheimer’s-related agitation, saying one trial succeeded while the other failed. Researchers looked at whether an Axsome program...
View ArticlePfizer ends work on Sangamo's hemophilia gene therapy, crushing biotech's hopes
Despite reporting a Phase 3 win this summer, Pfizer terminated its hemophilia A gene therapy pact with Sangamo Therapeutics in a move that cast a pall on the ...
View ArticleFlagship biotech Valo Health ends 2024 with mid-stage fail
Valo Health’s diabetic retinopathy drug failed to improve patients' symptoms in a Phase 2 study, and the company is now on the hunt for a partner. The company said Tuesday that ...
View ArticleRoche circles back to China biotech with $80M deal for lung cancer ADC
Roche is spending $80 million upfront on a new product from existing partner Innovent Biologics. The DLL3-targeting candidate for small cell lung cancer is the latest addition to its antibody-drug...
View ArticleNeumora's major depression drug flunks first of three Phase 3 trials
Neuroscience drug developer Neumora Therapeutics released highly anticipated results from the first of three Phase 3 trials for its experimental major depression drug, saying Thursday that navacaprant...
View ArticleThe top biotech megarounds of 2024
2024 was the year of the private megaround. Nine-figure financings dominated biotech's venture funding landscape, with 96 such rounds tallied by Endpoints News. The bevy of megarounds drowned out...
View ArticleHutchmed’s divestiture; Xgene reports Phase 2b win for non-opioid pain drug
Plus, news about Hookipa and Capricor Therapeutics: Hutchmed divests 45% stake in Chinese company: Hutchmed will get about $608 million in cash by divesting Shanghai Hutchison Pharmaceuticals Limited,...
View ArticleRegeneron buys London-based ocular biotech
Regeneron, maker of the blockbuster ophthalmology medicine Eylea, has acquired an ocular biotech, the large biopharma confirmed to Endpoints News on Thursday. The London-area biotech, named Oxular, was...
View ArticleFDA adcomm to review Novartis' Fabhalta in ultra-rare kidney disease
The FDA's Cardiovascular and Renal Drugs Advisory Committee is set to meet Feb. 24 to discuss Novartis' latest submission of Fabhalta in an ultra-rare kidney disease in which about half of patients...
View ArticlePennsylvania Blue Cross insurer restricts coverage of medicines granted FDA...
A Blue Cross Blue Shield licensee serving parts of Pennsylvania says it will not cover some therapies granted accelerated approval for at least 18 months after the FDA signs off. The
View ArticleBiopharma to raise more than 1,000 drug prices in 2025, advisory firm predicts
Drugmakers are expected to increase list prices on more than 1,000 medicines this year, and already raised the prices on about 250 drugs on Jan. 1, according to an analysis by the consultancy firm 3 ...
View ArticleAfter CagriSema, eyes are on Lilly’s oral GLP-1 as next key obesity play
With the disappointment of Novo Nordisk’s injected CagriSema in obesity at the end of 2024, there are questions around how much more injected next-gen weight loss ...
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