FDA rejects Savara’s rare lung disease drug over limited manufacturing data
The FDA has rejected Savara’s application for its rare lung disease candidate over insufficient chemistry, manufacturing and controls data, the clinical-stage biotech said Tuesday. Savara said it...
View ArticleFDA leadership preps for summer biopharma listening tour across six cities
FDA Commissioner Marty Makary, newly minted CBER chief Vinay Prasad and Principal Deputy Commissioner Sara Brenner are visiting six US cities in June and July to meet with biotech and pharma executives...
View ArticleRegulus execs expect $120M exit pay from Novartis takeover
Novartis won a bidding war against a fellow large drugmaker to acquire Regulus Therapeutics, according to a regulatory filing released Tuesday that described how the deal came together. The competitive...
View ArticleAxsome and Hetero settle patent fight over sleep disorder drug
Hetero Labs could launch its generic sleep disorder drug as early as 2040 under a settlement deal with Axsome Therapeutics. The settlement, announced Tuesday, resolves patent litigation between Axsome...
View ArticleInflaRx cans Gohibic development after skin disease trial stopped for futility
InflaRx will cease work on its intravenous complement inhibitor Gohibic for the skin condition pyoderma gangrenosum after an interim analysis indicated that a Phase 3 trial would fail. The study’s...
View ArticleUpdated: MD Anderson-allied investment firm targets $250M for second cancer...
Headed into the biggest oncology research and development confab of the year, an investment firm partnered with one of the nation’s premier cancer institutions is looking at a hefty second batch of...
View Article#ASCO25: Strand Therapeutics reports promising start for mRNA cancer therapy
A Boston biotech with self-replicating mRNA technology has shared early data from its lead candidate for cancers that are refractory to immune checkpoint inhibitors. Strand Therapeutics said on...
View ArticleEndpoints Livestream: Is the biotech market really as bad as it seems?
Today on Post-Hoc Live, we took a deep dive into Founding Editor John Carroll’s Endpoints 100 survey. Twice a year for almost a decade, John has sent a long list of questions ...
View ArticleA new dawn for psychedelics? Compass could be the first to find out
The summer of 2024 was a dark time for psychedelics. The sector was reeling after Lykos Therapeutics failed to secure FDA approval for its MDMA-assisted therapy for post-traumatic stress disorder....
View ArticleVeru’s obesity drug roughly as safe as Wegovy; Keros’ board fight
Plus, news about Advanz, Alvotech and GeNeuro: Veru’s obesity drug generally safe when added to Wegovy: In the Phase 2b QUALITY trial, patients who were given enobosarm, an oral androgen receptor...
View ArticleWeeks after TIGIT fail, iTeos decides to wind down
Only 15 days after saying it was searching for strategic alternatives, iTeos Therapeutics' board has determined its answer: It will be shutting down. The move comes quickly after GSK and iTeos ...
View ArticleGSK, Spero report Phase 3 win for UTI antibiotic; Spero's stock soars
GSK and Spero Therapeutics announced that a Phase 3 trial for their complicated UTI antibiotic reached its primary endpoint, setting up a potential FDA decision later this year and significantly...
View ArticleExclusive: Insurance startup Devoted Health cuts 5% of workers in small layoff
Devoted Health, the Medicare Advantage insurer with a medical group, has laid off about 120 employees, a company spokesperson confirmed to Endpoints News. The layoffs, which occurred May 19, affected...
View ArticleNovo Nordisk ‘strongly’ urges US away from pharma tariffs
Novo Nordisk warned the US government not to impose pharma-specific tariffs, but instead to tax illegal importers of semaglutide, as comments for the Department of Commerce’s investigation into the...
View ArticleWill the FDA approve Moderna's next-gen Covid shot?
After months of speculation, the US’ stance on Covid-19 vaccines under HHS chief Robert F. Kennedy Jr. is coming into focus with a new approval framework, new immunization guidance and, more broadly, a...
View ArticleTrump axes Moderna bird flu pact worth more than $750M
The Trump administration has killed an award worth $766 million to help Moderna develop a bird flu vaccine, according to the company. The biotech said Wednesday that it received notice from the...
View ArticleMovement disorder biotech Vima steps onto scene with $60M
Since Bernard Ravina's medical training in neurology in the 1990s, there have been few new therapies that treat a movement disorder known as dystonia. "Nothing fundamentally has changed for these...
View ArticlePepGen ditches Duchenne programs after mid-stage fail
PepGen is abandoning its exon 51-skipping Duchenne muscular dystrophy candidate after it failed a Phase 2 trial. And it is getting out of the disease altogether as it discards three preclinical...
View ArticleOric locks down cash for Phase 3 prostate cancer trial with early data in hand
Oric Pharmaceuticals has secured funds to support a planned Phase 3 study of its prostate cancer drug scheduled for 2026 after early results showed “broad and deep” clinical responses. The California...
View ArticleFDA rejects Stealth's rare disease drug, but offers potential for accelerated...
After a slight delay, the FDA rejected Stealth BioTherapeutics' Barth syndrome drug application for elamipretide, the company said early Thursday, but will consider a resubmission via the accelerated...
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