FDA 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 ...
View ArticleGSK’s Nucala bags another China approval, but biggest test yet to come
GSK’s blockbuster respiratory drug Nucala has secured a China label expansion for certain patients with inflamed sinuses. But a more important challenge on the way to hitting its multibillion-dollar...
View ArticleNovo petitions FDA over Victoza compounding as first generic wins approval
Novo Nordisk is continuing its citizen petition crusade at the FDA, this time aiming to stop the compounding of Victoza, its blockbuster GLP-1. The push comes as the regulator late last month
View ArticleEli Lilly seeks to join lawsuit over end of tirzepatide shortage
Eli Lilly has asked to intervene in litigation between a compounding pharmacy trade group and the FDA over the agency’s decision to remove Lilly’s blockbuster obesity and diabetes drug tirzepatide from...
View ArticleFlorida car dealer joins insulin pricing fight against Eli Lilly, Sanofi
A Florida-based car dealer has joined mounting litigation against Eli Lilly, Novo Nordisk and Sanofi over what it calls the “exorbitant” price of insulin. Braman Motors is the first private company to...
View ArticleNeumora fails Ph3 depression study; Our review of 2024 megarounds; Pfizer...
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 ArticleFDA drug approvals 2024: Rare diseases, schizophrenia and Alzheimer's
2024’s novel drug approvals offered a wide array of new cancer drugs, rare disease treatments, a potential Alzheimer’s blockbuster, and about 10 fewer approvals than 2023. While 2022 and 2023 saw major...
View ArticleI-Mab stops work on CD73; Citius to pursue ‘strategic’ options
Plus, news about General Proximity and PBS Biotech: I-Mab pauses CD73 development: The company is not moving forward with a program called uliledlimab to focus on a separate drug, a bispecific ...
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