CHMP recommends five new drugs, reconsiders Eli Lilly’s Kisunla
The European Medicines Agency’s human medicines committee (CHMP) recommended the authorization of five new medicines this week and announced that it has begun its reexamination of Eli Lilly’s...
View Article#ADA25: Vertex's diabetes cell therapy allows 10 patients to come off insulin
Vertex Pharmaceuticals’ cell therapy for type 1 diabetes allowed 10 of 12 patients (83%) to stop taking insulin a year after they were infused, according to results presented Friday. The data came from...
View ArticleFDA unveils new pilot program; Sage finds a buyer; Eli Lilly to acquire...
Welcome back to another edition of Endpoints Weekly, and happy start to the summer! The North Pole reached its maximum tilt toward the sun at 2:42 a.m. UTC this morning (10:42 p.m. Friday night on ...
View ArticleA puzzling update from Novo Nordisk and new data from Roche at #ADA25
The annual meeting of the American Diabetes Association is underway in Chicago. The confab has already yielded a major update from Vertex Pharmaceuticals and more exciting data are on the way. But ...
View ArticleCompass reports Phase 3 depression data for psilocybin drug
Compass Pathways said Monday its psilocybin drug has cleared the first of two late-stage tests in a challenging form of depression as it advances toward the potential of becoming the first classical...
View ArticleIllumina to buy SomaLogic for $350M upfront, pushing further into proteomics
Illumina has agreed to pay $350 million upfront for SomaLogic, the companies announced on Monday, in a deal that underscores the DNA giant's strategy of offering a broader look at biology. SomaLogic...
View Article#ADA25: Lilly’s bimagrumab boosts weight and fat loss when added to Novo's...
Eli Lilly’s muscle-boosting drug allowed obese patients who are taking Novo Nordisk’s Wegovy to retain almost all of their lean tissue, according to data presented Monday. The data are from a Phase 2b...
View ArticleTop drug regulator to depart FDA in July
The top drug regulator at the FDA is retiring, according to an email reviewed by Endpoints News and confirmed by several individuals within the agency. Jacqueline Corrigan-Curay, who’s been at the...
View ArticleCidara's preventive influenza biologic is effective in Phase 2b trial
Cidara Therapeutics’ long-acting antiviral biologic effectively prevented seasonal flu infections in a mid-stage trial, the biotech said Monday. Its shares {$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,...
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