Makary calls for 'America First' drug user fee renegotiations
FDA Commissioner Marty Makary is embracing the Trump administration's "America First" mantra, seeking potentially higher user fees for companies operating outside the US. "If your Phase 1 trial is not...
View ArticleSenator questions Lilly CEO on details of Trump deal for weight loss drugs
In a letter on Tuesday to Eli Lilly CEO David Ricks, Sen. Ruben Gallego (D-AZ) said the company needs to explain the details of its deal with the Trump administration over its weight loss drugs ...
View ArticleNew report suggests America must wean off China APIs
An annual report to Congress on China’s global reach says the US is overreliant on China’s production of active pharmaceutical ingredients, posing a national security concern to the pharma supply...
View ArticleNabla Bio announces AI antibody model update in JAM-2
The newest version of Nabla Bio's flagship AI model is creating antibodies that look more and more like possible drugs and is showing early hints at how the work might shave sizeable chunks off R ...
View ArticleAlkermes ups bid for Avadel after Lundbeck tried snatching narcolepsy biotech
The biopharma bidding wars are heating up. Like the battle for obesity biotech Metsera that recently ended, the fight over narcolepsy drugmaker Avadel Pharmaceuticals has led the original winning...
View ArticleGSK picks LTZ Therapeutics in myeloid cell engager pact worth $50M upfront
GSK will pay LTZ Therapeutics $50 million upfront for access to its myeloid cell engager (MCE) technology. The deal follows similar moves by Eli Lilly, Sanofi, Novartis and Pfizer aimed at developing...
View ArticlePfizer's antibody pact with Nona Biosciences; Epkinly's label expansion
Plus, news about GSK, Eledon, Hanmi Pharmaceutical, Aptose Biosciences, Rafa Laboratories and Eli Lilly: 🔬 Pfizer’s preclinical antibody discovery deal with Nona Biosciences: In a non-exclusive...
View ArticleMerck says once-daily HIV drug combo succeeds in another Phase 3
Merck secured another win on Wednesday in its plan to bolster its HIV portfolio. The pharma giant said its two-drug combination was non-inferior to a three-drug package in a Phase 3 ...
View ArticleAI biotech Profluent closes $106M raise with Jeff Bezos' support
Jeff Bezos' investment firm pitched in to a $106 million financing for Profluent, an AI-focused biotech startup that has a nearly $1 billion valuation. Profluent was founded in 2022, advancing research...
View ArticleProtara trumpets small rare disease dataset in children for cell therapy
Protara Therapeutics on Wednesday revealed new data showing its experimental bladder cancer cell therapy could also have potential in a rare pediatric disease. In a small, open-label Phase 2 dataset,...
View ArticleNew prime editing approach could create one-size-fits-many therapies
Researchers led by Broad Institute gene editing star David Liu have come up with a new use for prime editing that can tackle a bucket of diseases with the same root cause, which they say ...
View ArticleAgios' sickle cell trial falls short as drug doesn't appear to help patient...
Agios Pharmaceuticals’ drug Pyrukynd hit only one of the two primary endpoints in its pivotal trial in sickle cell disease, the company said Wednesday, a significant setback for the company's plans ...
View ArticleLife sciences sector ‘has lost confidence’ in the UK, committee member says
UK Health Secretary Wes Streeting has come under fire again after the chair of the Science, Innovation and Technology Committee said that the government needs to urgently improve drug pricing and...
View ArticleNew tuberculosis treatment shows potential in a Phase 2 study
A new antibiotic for tuberculosis outperformed other treatment options without compromising safety in drug-sensitive patients, according to trial results released Wednesday. The TB Alliance reported...
View ArticlePfizer CFO says drugmaker will 'supplement' Metsera deal as part of broader...
Now that Pfizer has acquired Metsera, the New York drug giant is likely to be peppered with questions about its obesity R&D strategy going forward. That was evident during Pfizer CFO Dave ...
View ArticleFDA approves Bayer’s HER2-mutated lung cancer drug
The FDA on Wednesday granted accelerated approval to Bayer’s targeted lung cancer drug for certain HER2 mutations, setting up competition with a Boehringer Ingelheim drug that was recently approved for...
View ArticleLab testing startup Function Health raises $298M Series B
Lab testing startup Function Health raised $298 million as more people grow interested in understanding their own health data. Redpoint Ventures led the Series B, which boosted Function's valuation to...
View ArticleFlagship's Tessera to start first human trial using new gene writing platform
Tessera Therapeutics confirmed that next month it will begin its first human trial for its in vivo gene writing platform, and plans to test it in adults with a rare genetic disease known as alpha ...
View ArticlePBMs, FTC clash in court over agency’s in-house insulin challenge
An attorney for the nation’s three major pharmacy benefit managers told a federal appeals court on Wednesday that the companies would “unquestionably” be harmed if FTC proceedings against them are...
View ArticleEnsoma halves workforce as genetic medicines startup enters clinic
Ensoma, a startup developing one-time genetic medicines, has shrunk its workforce shortly after beginning its first clinical trial and raising fresh capital. The Boston-based startup let go of 37...
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