Sofinnova’s Jim Healy on ‘more rational market’ as four biotech startups near...
In what’s shaping up to be another slow year for biotech IPOs — better, however, than the 2022 and 2023 doldrums — Jim Healy is somewhat of an outlier. Only four biotechs from this year’s IPO class are...
View ArticleCharles River to lay off 3% of staffers as it streamlines spending
Charles River Laboratories is cutting around 3% of its total workforce in “response to current trends,” a company spokesperson told Endpoints News in an email. The Wilmington, MA-based company is...
View ArticleFulcrum's Phase 3 for old GSK drug fails, stock sinks
Fulcrum Therapeutics reported a Phase 3 fail Thursday morning, sending its stock plummeting. The biotech said that a study testing the former GSK cardio drug losmapimod in facioscapulohumeral muscular...
View ArticleGSK’s mRNA flu shot is heading to Phase 3; Summit’s $235M offering
Plus, news about Oruka Therapeutics, Centessa, Takeda, Innate Pharma and Liquidia: GSK’s mRNA flu vaccine succeeds against both strains in Phase 2: The pharma company said the vaccine candidate...
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Debiopharm, ITM ink €300M licensing deal for cancer treatment
Debiopharm and ITM announced a licensing deal for a radiopharmaceutical treatment that’s being investigated in several cancers. Andrew Cavey Debiopharm, which is based in Switzerland, is eligible for...
View ArticleAustralian RNA manufacturer launches; Forge Biologics’ CEO steps down
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. A new RNA therapeutics manufacturing company based in Sydney,...
View ArticleFDA should embrace new ways of evaluating rare disease drugs, report argues
To increase the pace of rare disease drug approvals, the FDA should embrace nontraditional data, deploy new forms of analysis and be more open about its decisions, according to a new report from the...
View ArticleAvadel's narcolepsy drug Lumryz misses PDUFA date, still under review at FDA
Avadel Pharmaceuticals is still waiting on an answer from the FDA on whether its once-nightly narcolepsy drug Lumryz will be approved to include the pediatric population after the agency missed the...
View ArticleFDA revisits new structure for drug review documents, aiming to better...
Back in 2019, as part of a program focused on improving documentation and communications for drug approvals, the FDA made a change to how it explains its decisions. At the time, academics and industry...
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Seres' microbiome therapy reduces infections in stem cell transplant...
Seres Therapeutics, the biotech company that pioneered one of the first microbiome drugs, a pill containing bacterial spores purified from poop, announced promising but early results for a new...
View ArticleRoche’s Tecentriq scores first US approval for subcutaneous PD-1
Just in time for the first day of ESMO, the FDA has approved its first-ever subcutaneous immunotherapy targeting PD-1 for cancer. The new formulation of Roche’s Tecentriq — to be marketed as Tecentriq...
View ArticleBicara, Zenas and MBX rekindle IPO market with rare Friday tripleheader
After a sleepy few months, the biotech IPO market is waking up thanks to back-to-back-to-back listings. Oncology-focused Bicara Therapeutics, autoimmune startup Zenas BioPharma and metabolic drug...
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Neurocrine culls Phase 2 neuropsych med after failing to validate earlier data
Neurocrine is halting further development of luvadaxistat after it failed to improve cognitive impairment in patients with schizophrenia in a mid-stage study. The company said in a Thursday update that...
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Oncternal stops cancer trials and begins search for future business options
After disappointing efficacy data and a patient death, Oncternal Therapeutics is discontinuing two trials and looking for strategic alternatives. The San Diego company said it would end a Phase 1 trial...
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Doug Williams returns with a ‘FIT’ bet on CAR-Ts; Biogen appoints Mene...
Doug Williams Industry veteran Doug Williams is back with a new approach to CAR-T cell therapies that he expects to take into the clinic in the US by year’s end. After a brief stint at Sana...
View ArticleValneva raises about €61M; Immuneering details new Phase 2a data
Plus, news about ONL Therapeutics, Cidara Therapeutics, Emergent BioSolutions, Vico Therapeutics and Centessa: Valneva gets €61.2M private placement: Valneva said the funds will go toward supporting...
View ArticleOnline stimulant prescriptions soared during Covid pandemic, study finds
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Stimulants prescribed during telehealth visits rose dramatically during the Covid-19 pandemic, when...
View ArticleWHO pre-qualifies Bavarian Nordic’s vaccine as first mpox shot
Bavarian Nordic has secured the first mpox vaccine pre-qualification from the World Health Organization since the disease outbreak was declared an emergency a month ago. The vaccine, dubbed MVA-BN, is...
View ArticleFDA approves subcutaneous Ocrevus, broadening access to Roche and Genentech...
The FDA on Friday approved a new formulation of Roche and Genentech’s multiple sclerosis drug Ocrevus in what they hope will broadly expand access to the treatment. Patients will now be able to take...
View ArticleAurinia restructures board, bringing in Kevin Tang and keeping CEO
Aurinia Pharmaceuticals offered an olive branch to a group of shareholders clamoring for change. It’s shrinking its board by two seats, and it added activist investor Kevin Tang. CEO Peter Greenleaf...
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