Top drug regulator to depart FDA in July
The top drug regulator at the FDA is retiring, according to an email reviewed by Endpoints News and confirmed by several individuals within the agency. Jacqueline Corrigan-Curay, who’s been at the...
View ArticleCidara's preventive influenza biologic is effective in Phase 2b trial
Cidara Therapeutics’ long-acting antiviral biologic effectively prevented seasonal flu infections in a mid-stage trial, the biotech said Monday. Its shares {$CDTX} were up 95% in early trade on the...
View ArticleFormation Bio’s up to €545M licensing deal with Sanofi; Otsuka, Harbour...
Plus, news about Incyte, Carisma Therapeutics, Idorsia, Leap Therapeutics, Enterome, Merck, Forte Biosciences, Enzon and Viskase: Formation Bio licenses JAK/SYK inhibitor to Sanofi: The startup said...
View ArticleNovo Nordisk ends partnership with Hims over compounded drugs
Novo Nordisk has ended its unlikely partnership with Hims & Hers after less than two months. In late April, the pharma giant started allowing Hims, along with other telehealth companies, direct...
View ArticleExelixis' positive Phase 3 colorectal cancer data boost stock
Shares {$EXEL} of Exelixis jumped after the company reported positive Phase 3 data from one of its cancer studies. Exelixis said Monday that a combination of its oral TKI inhibitor zanzalintinib ...
View ArticleSupreme Court asks DOJ to weigh in on Hikma ‘skinny label’ fight
The US Supreme Court on Monday invited the US solicitor general to comment on a generic drug label case that Hikma Pharmaceuticals says could “effectively vitiate” a common practice for bringing...
View ArticleRoche plans to pit next-gen hemophilia A antibody against Hemlibra in Phase 3
Roche is moving its next-generation hemophilia A treatment into Phase 3 testing next year after seeing the early-stage data. The pharma disclosed Monday that part of the Phase 3 program will ...
View ArticleFDA approves AstraZeneca, Daiichi Sankyo's Datroway in EGFR-mutated lung cancer
The FDA on Monday approved AstraZeneca and Daiichi Sankyo’s TROP2-targeting drug Datroway in a new lung cancer indication, broadening the amount of patients for what the company hopes is their next big...
View Article#ADA25: Amgen plans more gradual MariTide dosing in Phase 3
Amgen intends to dose its long-acting obesity shot MariTide at a lower level in its Phase 3 than it did in Phase 2, after the drug’s side effects proved unmanageable in mid-stage research. The adverse ...
View ArticlePolitics collide with science ahead of new ACIP meeting
A newly-rebuilt CDC vaccine advisory panel will meet for the first time this week, informing whether the US' public health agency will continue to back data and evidence that have long guided its...
View ArticleNuvalent closes in on FDA filing for lung cancer drug with topline Phase 1/2...
Nuvalent has shared positive data for its ROS1 inhibitor from a “pivotal” mid-stage lung cancer study, and plans to start a rolling NDA submission next month. The biotech’s candidate, called...
View ArticleUK government blueprints ambition to be a key life sciences hub
The UK government has provided big picture plans to help it reach its target of becoming the leading life science center in Europe by 2030 and the third in the world by 2035, behind the ...
View ArticleArriVent plots next steps for lung cancer drug; Neuron23's $96.5M raise
Plus, news about Rivus, Amarin, Recordati, Liquidia, Healthcare Royalty, Lexeo, Perceptive, venBio, Novo Nordisk and Cidara: ArriVent to start another Phase 3 of lung cancer drug: In a Phase 1b trial,...
View ArticleNektar reports positive Phase 2b rezpeg data in eczema, stock skyrockets
Nektar Therapeutics is blazing a comeback trail for a drug it once worked on with Eli Lilly, trumpeting positive Phase 2b data on Tuesday that Wall Street found exceptional. Nektar said...
View ArticleRevolution secures up to $2B from Royalty Pharma in custom funding deal
Revolution Medicines has signed a “flexible funding agreement” with Royalty Pharma for up to $2 billion that should support it through late-stage development of its lead RAS inhibitor and beyond. The...
View ArticleSources: FDA chief Makary sought rejection of KalVista's drug
Multiple agency sources said FDA Commissioner Marty Makary was behind a short-lived request last week to reject a rare disease drug application from KalVista Pharmaceuticals that remains under agency...
View ArticleFormer Pfizer CSO Mikael Dolsten joins board of gene editing startup
Mikael Dolsten, Pfizer's former chief scientific officer who led the company’s Covid-19 vaccine development, has joined the board of Arbor Biotechnologies, a gene editing startup working on therapies...
View ArticleNovo and Hims' crossed wires
Back in April, I was surprised (and skeptical) when Hims said it was teaming up with Novo Nordisk to offer its members discounted Wegovy — just the start of a long-term collaboration with the pharma...
View ArticleRFK Jr. refutes that he guaranteed to keep ACIP's roster
A day after Sen. Bill Cassidy (R-LA) called for a delay to this week’s Advisory Committee on Immunization Practices meeting, HHS chief Robert F. Kennedy Jr. said he did not guarantee to preserve the...
View ArticleFDA hires former FDA scientist Michael Davis as CDER deputy director
The FDA is bringing back Michael Davis as the next deputy director of the Center for Drug Evaluation and Research, according to an internal memo viewed by Endpoints News. Davis’ hiring comes a day...
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