Purdue’s emergency opioid overdose treatment is approved by the FDA
Purdue Pharma on Wednesday won FDA approval for its emergency treatment for opioid overdose as the company attempts to distance itself from its role in the opioid epidemic. The nalmefene hydrochloride...
View ArticleGilead shells out $320M to J&J to buy out rare liver disease drug royalties
Gilead is spending $320 million to buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug seladelpar a week before the FDA is expected to decide whether to approve it. In...
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AN2 Therapeutics undergoes makeover after late-stage lung disease trial...
AN2 Therapeutics said it will shut down a late-phase study of its lead candidate in bacterial lung disease and then go through a company overhaul. The placebo-controlled Phase 2/3 trial was testing the...
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Bill Haney's Dragonfly nabs former Cerevel CFO; Cellectis' new CMO
Susan Altschuller → Bill Haney’s Dragonfly Therapeutics has brought aboard Susan Altschuller as CFO. Altschuller’s résumé includes other finance chief roles at Cerevel Therapeutics and ImmunoGen, which...
View ArticleExclusive: MIT spinout launches with focus on improving DNA payloads for gene...
We often imagine DNA as a stringlike molecule that’s easily scrunched up. But our six-foot-long genomes only fit inside our cells thanks to an intricate spooling system. Left on its own, DNA’s famed...
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Merck pays $700M for clinical-stage CD3xCD19 bispecific antibody
Merck is making its fourth acquisition of the year, this time buying a single asset from a Shanghai-based cancer drug developer. The New Jersey pharma giant said Friday it is dishing out $700 million...
View ArticleFDA lifts hold on 4DMT's Fabry gene therapy
The FDA lifted an 18-month clinical hold on 4D Molecular Therapeutics’ cardiomyopathy gene therapy for Fabry disease. The biotech said Thursday it expects to resume enrollment in the Phase 1/2 INGLAXA...
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Novavax plots to reduce European manufacturing footprint to become a ‘leaner’...
Jim Kelly Novavax is “actively exploring” to divest its manufacturing facility in the Czech Republic as the company continues to face dwindling demand for its vaccines, CFO Jim Kelly said. Novavax...
View ArticleA CAR-T deal in China; Zevra’s $60M offering
Plus, news about Arrowhead, Cullinan Therapeutics, Cytokinetics, Zentalis, Inovio and Mind Medicine: Domestic biotech M&A in China: Northeast Pharmaceutical Group, a decades-old maker of generics...
View ArticleAvidity CEO says it's ‘full steam ahead’ in DMD as stock rallies on Phase 1/2...
The Duchenne muscular dystrophy community received some rare good news on Friday when Avidity Biosciences reported surprisingly positive clinical results in DMD and plans to advance its RNA therapy....
View ArticleAutoimmune CAR-Ts are under the microscope after Cabaletta’s safety issue in...
Eyes are on CAR-T therapy clinical trials in autoimmune diseases for potentially more serious side effects, after Cabaletta Bio’s candidate was linked with a high-grade neurotoxicity event in one lupus...
View Article23andMe trades drug discovery for GLP-1 weight loss prescriptions
23andMe is shutting down its internal drug discovery group and getting into prescription weight loss drugs in an effort to turn the struggling consumer genetic testing company around. The company said...
View ArticleAlfasigma's PBC treatment Ocaliva to face an FDA adcomm in September
Italian pharma Alfasigma will face an FDA advisory committee next month to discuss the full approval of its rare liver disease treatment Ocaliva, a drug the company acquired less than a year ago. The...
View ArticleGenentech, Gilead push FDA to modernize research inspections
Roche’s Genentech, Gilead, Sanofi and other drugmakers weighed in on the FDA’s recent draft guidance on research inspections, with the companies calling for clarity and further commitment from the...
View ArticleHello, neffy: FDA approves first nasal spray for severe allergic reactions
Over the last 40 years, twin packs of EpiPens became a fixture for people and parents with children experiencing severe allergic reactions. Now, ARS Pharmaceuticals hopes that a new intranasal option...
View Article'Amgen India' to be operational later this year
With operations beginning in the fourth quarter, Amgen said Friday that it is opening a new site in Hyderabad, India, with 3,000 employees. Dubbed a tech and innovation facility to “accelerate digital...
View ArticleOhio federal judge dismisses IRA suit brought by US Chamber of Commerce
The federal government has defeated another lawsuit against the Inflation Reduction Act, this time brought by the US Chamber of Commerce. An Ohio federal judge dismissed the case on Thursday,...
View ArticleLykos’ MDMA-assisted PTSD treatment rejected by FDA after troubled trial and...
The FDA has rejected Lykos’ MDMA-assisted treatment for patients with post-traumatic stress disorder, a major setback for the company that had hoped to translate more than two decades of research into...
View ArticleLatest on MDMA rejection; Novo vs. Lilly earnings; Recursion, Exscientia to...
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...
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FDA delays approval decision on Humacyte’s lab-grown blood vessels
A potential medical breakthrough more than two decades in the making will have to wait a little longer before becoming widely available. Humacyte, which has developed lab-grown blood vessels to treat...
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