Inside Makary’s ouster; Another win for Lilly’s triple-G; and more
Welcome back to another edition of Endpoints Weekly! My usual co-author Nicole DeFeudis was out this week on a much-deserved vacation, so I’m instead joined by Kyle LaHucik in rounding up the...
View ArticleFDA clears Gilead's hepatitis D drug, four years after prior rejection
Gilead has at long last won US approval of its hepatitis D treatment Hepcludex, which the FDA previously rejected over issues with its manufacturing and distribution. The drug, known generically as...
View ArticleGOP lawmaker asks Trump administration to curb China biotech deals
A key Republican congressman asked the Trump administration to restrict the stream of money into China’s biotech sector, threatening to squelch the dealmaking that’s become big business for some US...
View ArticleAstraZeneca wins EU backing for breast cancer drug, splitting with FDA panel
An AstraZeneca breast cancer drug received a positive opinion from European regulators, despite an FDA advisory committee voting against the drug last month. Novo Nordisk’s Wegovy pill also got the EU...
View ArticleHow Utah’s AI prescribing experiment is going so far
Utah has released early data from a closely watched program that tests using AI to renew prescriptions for patients with chronic conditions. Since mid-December, Doctronic has been automating...
View ArticleFDA grants Daiichi Sankyo and AstraZeneca’s Datroway a key breast cancer...
The FDA has approved the TROP2-directed antibody-drug conjugate Datroway as a first-line option for triple-negative breast cancer, giving Daiichi Sankyo and AstraZeneca a leg up over their competitor...
View ArticleTender offer for Recordati; Sobi's gout drug passes Phase 3 test
Plus, news about Immunovant and Retro Biosciences. 💸 CVC and GBL launch tender offer for Recordati: CVC Capital Partners and Groupe Bruxelles Lambert (GBL), a Belgian investment holding company,...
View ArticleWhy one health AI unicorn is giving away its service for free
As health tech gets more competitive, a strategy companies use to stand out is providing their products for free. They’re betting this will help build up a large and loyal ...
View ArticleNovartis says Avidity's science could apply beyond muscular dystrophies
Novartis said it's working to get the most out of its $12 billion acquisition of Avidity Biosciences by finding ways to apply its underlying science to diseases beyond muscular dystrophy. The...
View ArticleBiogen, Denali to drop drug in non-genetic Parkinson’s after mid-stage study...
Biogen and Denali Therapeutics’ LRRK2 inhibitor has flunked a Phase 2b trial in early Parkinson’s disease, leading the companies to drop the program in certain patients. The small-molecule drug, known...
View ArticleIbrance heirs, Gilead's Tubulis data and more at #ASCO26
All of the regular ASCO abstracts dropped Thursday afternoon, with the biggest news coming from the VEGF bispecific race, Merck and Kelun-Biotech’s TROP2 ADC known as sac-TMT, and multiple ...
View ArticleAmgen CFO to follow David Reese into retirement; Josh Smiley is out at Zai Lab
→ Peter Griffith will be the second high-profile exec to leave Amgen this year when he retires on Sept. 1. Thomas Dittrich will replace him as CFO and return to Amgen ...
View Article#ASCO26: Merck partner Kelun outlines Phase 3 lung cancer success in China study
Merck partner Kelun-Biotech fleshed out a Phase 3 win in lung cancer from a study in China for the experimental antibody-drug conjugate sac-TMT, raising hopes that the benefit could translate to...
View Article#ASCO26: Key head and neck cancer readouts from J&J, Corbus, Summit, Akero...
Head and neck cancer has always been a tough nut to crack. These tumors can suppress immune responses through multiple pathways, meaning blocking one of those usually isn’t enough. Merck’s Keytruda is...
View Article#ASCO26: New data released for VEGF bispecifics from BioNTech-BMS, Pfizer-3SBio
Much of the attention heading into the annual ASCO meeting next week has focused on Summit Therapeutics and Akeso’s plenary presentation for their bispecific drug ivonescimab. But two of ivonescimab’s...
View ArticleHow a group of biotechs ran a covert campaign to push out the FDA commissioner
Biohaven CEO Vlad Coric finally had the attention of the FDA, and most importantly, Commissioner Marty Makary. In late April, after the company’s spinocerebellar ataxia drug had been rejected last...
View ArticleChina’s drugmakers to take the stage at #ASCO26
It’s no secret that Akeso’s presentation will be one of the most closely watched readouts from the American Society of Clinical Oncology annual meeting this year. Slated for May 31, HARMONi-6 marks the...
View ArticleBioMarin to seek further approval of Voxzogo in form of short stature
BioMarin Pharmaceutical will seek expanded approval for its bone growth-stimulating drug Voxzogo after the shot improved growth speed in children with a form of short stature, the company said...
View ArticleIncyte signs AI deals with Genesis Molecular AI, Edison Scientific
Over a 35-year history, Incyte has grown into a $19 billion biopharma company. The Delaware-based drugmaker is now turning to AI to power through the coming decades.
View ArticleBMS eyes new campus in Texas; Novartis looks to evict tenant at Slovenian campus
Plus, news about Gilead and West Pharma: 🏭Bristol Myers Squibb looks to Texas: The drugmaker is considering building a new pharma campus in Generation Park Management District in Houston, TX, which ...
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