WuXi Biologics gains some traction in Europe in the face of Biosecure threat...
WuXi Biologics appears to be making some progress in Europe in recent days, after securing a new biotech partner and EMA certifications for its manufacturing sites in China. On Thursday, the German...
View ArticleLilly contributes to isotope supplier fundraise; Layoffs at Ajinomoto
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Eli Lilly is injecting some funding into Ionetix for the isotope...
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Lilly says to ‘take some caution’ on other companies’ early-stage obesity...
After posting a blowout quarter of financial results, Eli Lilly has almost made the obesity business look easy. But amid investors’ enthusiasm for weight loss drugs, the company’s top scientist warned...
View ArticleAldeyra to resubmit dry eye disease drug this year following positive Phase 3...
Aldeyra Therapeutics plans to make another run at FDA approval for its dry eye disease drug after the agency handed down a complete response letter last year. The company said Thursday that a Phase 3...
View ArticlePurdue’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...
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