Alphabet-backed Isomorphic Labs to open US office, hires ex-Relay CMO
Isomorphic Labs has hired its first chief medical officer to help establish the company's first US office, the Alphabet-backed biotech said Tuesday. Isomorphic has quickly become a leading startup...
View ArticleDyne pivots on primary endpoint, delays filing for DM1 drug
Dyne Therapeutics met with the FDA to discuss what's needed for the accelerated approval of its myotonic dystrophy drug, and it settled on a different primary endpoint than expected. The company also
View ArticleMineralys' lorundrostat gets a Phase 2 win in certain patients with hypertension
Mineralys Therapeutics said Tuesday that its blood pressure med lorundrostat has succeeded in a Phase 2 trial in subjects with hypertension and comorbid chronic kidney disease (CKD). The data will be...
View ArticleProthena moves forward with layoffs; Aldeyra resubmits dry eye drug to FDA
Plus, news about Ventyx Biosciences, Gilead Sciences, Insilico Medicine and Enliven Therapeutics: Prothena lays off 91 workers: The company previously disclosed plans for a "substantial" workforce...
View ArticleLyell’s lymphoma data for recently acquired CAR-T receive lukewarm reception...
Lyell Immunopharma’s recently acquired CAR-T doesn't appear to impress Wall Street. The company said Tuesday that its dual-targeting CD19/CD20 CAR-T called LYL314 induced 22 responses in a cohort of 25...
View ArticleAI biotech Xaira unveils virtual cell research paper
Last spring, Xaira Therapeutics launched with over a billion dollars, a star-studded team and big dreams to remake R&D with AI. The South San Francisco-headquartered startup has been fairly quiet...
View ArticleFDA unveils pilot to speed some new drugs to market in just one month
A new FDA pilot program unveiled Tuesday aims to significantly cut drug review times to support what Commissioner Marty Makary deems "national priorities." The one-year pilot will test out a new...
View ArticleFDA approves CSL’s prophylactic for severe swelling condition
CSL Behring won FDA approval on Monday for its once-monthly preventive treatment for a rare, genetic condition that causes swelling episodes. Andembry is approved to prevent attacks of hereditary...
View ArticleOrphan drug, PBM changes fall out of Trump tax bill in Senate version
The Senate Finance Committee’s version of a massive tax cut package omits some PBM reforms and other provisions from the House-passed version that change how orphan drugs are treated under the Medicare...
View ArticleLawmakers urge appeals court to maintain halt on NIH's payment cut plan
A group of members of the House of Representatives told a federal appeals court that the NIH’s planned cap on indirect cost reimbursements disregards Congress’ “exclusive authority to control federal...
View ArticleDraig Therapeutics unveils $140M Series A for neuropsychiatry pipeline
A UK biotech named after the Welsh word for dragon has emerged from stealth with a Phase 2-ready candidate for depression and an oversubscribed Series A fundraise backed by the venture arm of Sanofi. ...
View ArticleActio gets $66M for experimental epilepsy and Charcot-Marie-Tooth treatments
An impressive group of biopharma investors put $66 million into a San Diego startup called Actio Biosciences. The clinical-stage company said Wednesday morning that existing investor Deerfield...
View ArticleEndpoints Livestream: China is still the top conversation starter at BIO
Today on Post-Hoc Live, we’re bringing you interviews live from Boston, where several of our reporters have spent the last few days covering BIO's annual conference. This week, I’m taking over hosting...
View ArticleBavarian Nordic's PRV goes for $160M; Biomea to advance GLP-1 into trials
Plus, news about Camurus and Pelage Pharmaceuticals: Bavarian Nordic to sell its priority review voucher: The Danish pharma company will hand over the PRV to an undisclosed buyer for $160 million ...
View ArticleHumana details plans to grow its primary care clinics
As plenty of clinic chains shut their doors, Humana is growing its fleet of primary care centers, with plans to buy struggling competitors and the remaining stakes in dozens of clinics it co-owns with...
View ArticleTennr raises $101M Series C to fix faxes with AI
Tennr has raised Series C funding at a $605 million valuation to organize faxes in healthcare and automate them, eight months after its last round and a year after its Series A. Because healthcare...
View ArticleScholar Rock reports competitive data for muscle-preserving obesity drug add-on
Scholar Rock’s muscle-building antibody helped patients who are overweight or obese preserve lean mass when they were taking Eli Lilly’s incretin drug Zepbound, the biotech said Wednesday. In a Phase 2...
View ArticleA custom ALS drug could help scale rare disease therapies
In 2020, Jaci Hermstad died at age 26 from a rare and aggressive form of ALS. But her story didn’t end there. A drug that was created just for her, called Jacifusen, has since been ...
View ArticleBioNTech drops indications, stops making cell therapy at Maryland site
BioNTech said it's stopping work on an experimental cell therapy in certain indications, and is winding down cell therapy manufacturing at its Gaithersburg, MD site. “We have made the difficult...
View ArticleBIO's new chair on FDA changes, most favored nation pricing and China
BOSTON — Fritz Bittenbender, the newly-named chair of BIO, is guiding the group through the kind of split-screen experience that has defined the first several months of the second Trump administration....
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