FDA approves Liquidia's inhaled hypertension drug in two settings
The FDA approved Liquidia’s treprostinil program for two related kinds of high blood pressure, turning up the heat on rival United Therapeutics and its Tyvaso franchise. Treprostinil, now branded as...
View ArticleLilly to buy non-opioid pain biotech SiteOne for up to $1B
Eli Lilly is deepening its presence in the non-opioid pain field by buying California biotech SiteOne Therapeutics, which is in a similar arena as the recent landmark approval for Vertex's pain drug....
View ArticleRFK Jr. ends routine Covid vaccine guidance for kids, pregnant women
The CDC will no longer recommend routine Covid-19 vaccines for healthy kids and pregnant women after HHS Secretary Robert F. Kennedy Jr. axed existing guidance. Kennedy, joined by FDA Commissioner...
View ArticleBoundless Bio changes plans for cancer drug after toxicity issues
Boundless Bio has hit the reset button in the face of toxicity issues, nixing ongoing treatment arms in an early-stage cancer study in favor of a new combination for its CHK1 inhibitor. And in a ...
View ArticleSernova chair resigns following insider trading charges by DOJ
Canadian cell therapy biotech Sernova said Sunday that its board chairman Ross Haghighat has resigned after being indicted by the Department of Justice on Friday, with 16 counts of insider trading ...
View ArticleFDA 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...
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