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J&J expands Tremfya into IBD with new FDA approval
The FDA has approved Johnson & Johnson’s IL-23 blocker Tremfya to treat ulcerative colitis, a boost to the pharma’s hopes that the drug will serve as a worthy follow-up to the blockbuster Stelara....
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Sanofi buys into radiopharmaceutical field with $110M upfront, going after...
While it’s put more emphasis on becoming an “immunology powerhouse” in recent quarters, Sanofi still shows signs of interest in oncology. On Thursday it announced licensing deals with the radiopharma...
View ArticleModerna plans $1.1B in R&D and program cuts, delays break-even point to 2028
Stéphane Bancel has relented to Wall Street’s desire for cost-cutting and reining in Moderna’s pipeline. To kick off its annual R&D day in New York, Moderna said Thursday that it will slash its...
View ArticleAura's infrared light-activated drug stops tumor growth and preserves vision...
Aura Biosciences said eight of 10 patients with a rare eye cancer who received a therapeutic dose of its experimental virus-like drug conjugate saw their tumors stop growing at one year. Of the 10...
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F2G inks $100M Series H for another shot at treating fungal infections
Manchester, UK-based F2G has patched together another $100 million in funding a little over a year after receiving a CRL for its experimental fungal infection drug known as olorofim, it said Thursday...
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Cancer gene therapy startup Vironexis emerges from stealth with $26M seed round
A new startup attempting to develop AAV gene therapies to treat cancer emerged from stealth Thursday morning with $26 million in seed funding — and a plan to quickly get into the clinic. Vironexis...
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Noom offers compounded GLP-1 drugs, promises patients can quit and keep...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Noom is the latest weight loss startup to start prescribing compounded versions of the obesity...
View ArticleGilead says twice-yearly HIV prevention shot succeeds in second pivotal trial
Gilead announced that its twice-a-year HIV injection prevented all but two cases of HIV among 2,180 participants in a Phase 3 study as it prepares to launch the drug, called lenacapavir, in 2025 for...
View ArticleLilly budgets $1.8B to boost Kisunla, GLP-1 manufacturing in Ireland
Eli Lilly is rapidly increasing its presence in Ireland with a $1 billion expansion to bolster its biologic drug production and a separate $800 million investment to further grow its GLP-1...
View ArticleSofinnova’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...
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