FDA proposes smaller 2026 budget with more user fees than 2025
FDA Commissioner Marty Makary is calling on Congress to fill the agency's coffers next year with 4% less than 2025, including an 11% reduction in taxpayer funds but 4% more industry user fees. The...
View Article#ASCO25: Brain cancer cell therapies make early strides
Early efforts to use cell therapies for aggressive brain cancers are showing promise in a few patients, according to new data released at ASCO this past weekend, with some experiencing long responses...
View ArticleQ&A: Sandoz CEO talks generic GLP-1s, Trump's tariffs, Mark Cuban's company
Richard Saynor’s journey to becoming a self-described patent destroyer was largely by accident. Saynor has been CEO of Sandoz since 2019, but he started his career as a pharmacist before finding the...
View ArticlePyx Health buys FarmboxRx to reach more Medicaid and Medicare members
Pyx Health, built to support people through loneliness, has bought food delivery startup FarmboxRx to reach more members on Medicare and Medicaid plans. The acquisition announced Tuesday includes a...
View Article#ASCO25: BioNTech presents impressive early data for PD-L1xVEGF in mesothelioma
CHICAGO — BioNTech reported promising Phase 2 data in a rare and aggressive lung and abdomen cancer from its experimental PD-L1xVEGF compound, a drug that’s now at the center of a massive $1.5...
View ArticleExclusive: Canid raises $10M to manage vaccines for pediatricians
Providing vaccines to kids can be a major undertaking for a pediatrician's office. Stocking up on the shots can be expensive. Plus, there are the burdensome tasks of managing inventory, billing...
View ArticleVera redraws the terms of up to $500M credit facility; Trevi aims to raise $100M
Plus, news about Kamari Pharma, Leyden Labs, Kiora, Senju, Alto Neuroscience, Chase Therapeutics, Nxera Pharma, Neurocrine Biosciences, Aytu BioPharma and Fabre-Kramer: On heels of pivotal readout,...
View ArticleAgenus to divest CDMO business to Zydus for $75M upfront
Agenus is divesting its biologics CDMO business, which it launched only six months ago, to Indian drugmaker Zydus Lifesciences for $75 million upfront, an Agenus spokesperson told Endpoints News ...
View ArticleMakary tells Hawley he will review the abortion pill mifepristone
FDA chief Marty Makary told Sen. Josh Hawley (R-MO) this week that he’s “committed” to reviewing the abortion pill mifepristone, marking the clearest pledge to look into the drug since his confirmation...
View ArticleFDA's Vinay Prasad says he will 'rapidly' push forward rare disease advances
The FDA’s new head of biologics Vinay Prasad said he plans to "rapidly make available" even small advances in rare disease treatments, a sign of flexibility that undercuts earlier perceptions of Prasad...
View ArticlePharma companies rush in to buy what they hope will rival Keytruda
A series of major deals by some of the world’s biggest drugmakers has set off a race to own what could be the next major class of cancer drugs, a group of experimental therapies that ...
View ArticleEli Lilly inks deal with Camurus for its long-acting obesity tech
Eli Lilly has tapped Camurus in a deal worth up to $870 million for its drug delivery technology to develop four long-acting incretin candidates. The technology can be used on any of Lilly’s dual GLP ...
View ArticleSionna chooses Phase 2a cystic fibrosis drug after healthy volunteer study
Newly-public biotech Sionna Therapeutics is ready to head into mid-stage testing. In an update reporting healthy volunteer data for two cystic fibrosis drugs, Sionna said it will move SION-719 into a...
View ArticleExclusive: CinDome gets another $40M to advance gastroparesis drug
CinDome Pharma collected an additional $40 million from existing investors to run another Phase 2 study of its gastroparesis drug, CinRx CEO Jon Isaacsohn exclusively told Endpoints News. It's been...
View ArticleStruggling biotechs succumb to icy market, as money dries up and clinical...
In the span of 15 days, the fate of iTeos Therapeutics soured quickly. Once a beacon of the anti-TIGIT class, the company this spring faced two major issues: a key clinical failure for its cancer ...
View ArticleVigil drug fails a Phase 2; Merus aims to raise $300M
Plus, news about Bayer: Vigil Neuroscience's Phase 2 fail: The neurodegenerative disease biotech stopped a long-term extension trial of iluzanebart for a rare disease called adult-onset...
View ArticleAnaptysBio describes ‘JAK-like’ efficacy for PD-1 drug in rheumatoid arthritis
AnaptysBio is claiming success with longer follow-up data from a Phase 2b trial in rheumatoid arthritis as it looks for a partner to take its PD-1 drug into Phase 3. Back in February, the company ...
View ArticleSagimet touts China partner Ascletis' Phase 3 FASN inhibitor data in acne
Sagimet Biosciences' FASN inhibitor denifanstat succeeded in a China-based Phase 3 trial in moderate-to-severe acne that was run by its local partner Ascletis. While that trial is for the Chinese...
View ArticleEx-HHS workers accuse Kennedy of relying on flawed data to issue firings
The Trump administration is being accused of relying on faulty personnel data to fire 10,000 employees from federal health agencies, according to a proposed class action brought by seven laid-off...
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