Semaglutide, tirzepatide compounder hit with FDA warning letter
Compounding facility ProRx Pharmacy Network has received an FDA warning letter over issues with its semaglutide and tirzepatide production. The FDA uncovered several issues at ProRx’s facility in...
View ArticleOne February FDA adcomm meeting is delayed, another canceled
An FDA advisory committee meeting for a kidney drug has been canceled, and another meeting to discuss opioids has been delayed, amid ongoing confusion and disruption in several US government health...
View ArticleOzempic label expanded to include reduced risk of worsening kidney disease
The FDA on Tuesday broadened the label of Novo Nordisk's blockbuster diabetes drug Ozempic. The GLP-1 injectable can now also be marketed for the reduction in risk of worsening kidney disease ...
View ArticleAstraZeneca, Daiichi Sankyo bring Enhertu to HER2-ultralow setting
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu is now approved to treat a new subset of breast cancer patients with very low levels of HER2 protein. The blockbuster drug has been...
View ArticleLilly cuts mid-stage heart failure and chronic kidney drug
Eli Lilly is discontinuing a Phase 2 relaxin treatment candidate for heart failure and chronic kidney disease, a spokesperson for the company confirmed to Endpoints News. The drug, an under-the-skin...
View ArticleJudge allows Aurion Biotech's path to IPO despite Alcon objections
A Delaware judge issued a split ruling in a bizarre legal squabble over the IPO plans of Aurion Biotech, which should allow the cell therapy startup to go ahead with its public offering. The judge' ...
View ArticleZentalis resorts to layoffs as it prioritizes WEE1 inhibitor for cancer
Zentalis Pharmaceuticals is axing about 40% of its staff and doubling down on advancing its only pipeline candidate as part of a broader company reorg designed to save cash. The company had a tricky...
View ArticleKennedy hearing updates: Trump HHS nominee faces Senate
The first of two confirmation hearings begin on Wednesday for Robert F. Kennedy, Jr. to serve as President Donald Trump's HHS secretary. Kennedy is appearing before the Senate Finance Committee and is...
View ArticleTrump administration makes first comments on how it will run IRA drug...
The Trump administration said on Wednesday it will consider "opportunities to bring greater transparency” to the Medicare drug price negotiation process under the Inflation Reduction Act. With the...
View ArticleCurie.Bio has a new $340M fund; Layoffs at Benchling, I-Mab
Plus, news about Cullinan Therapeutics, Regulus and Imvax: Curie.Bio’s new $340M fund: The investment firm and biotech startup incubator disclosed the second seed fund on Wednesday. Curie.Bio generally...
View ArticleLonza looks to buy facilities and tech to boost service offerings
Lonza said Wednesday morning it is on the hunt for deals to increase its capacity and technology offerings, which comes after its revenues took a small hit last year and it recently revealed plans to ...
View Article8VC, a tech and life sciences VC firm behind Altos Labs, eyes $1B fund
8VC, a venture capital firm that has spread its bets across multiple industries, including biotech and digital health, is aiming to raise about $1 billion for its sixth fund, according to a new SEC ...
View ArticleTeva CEO says Austedo can grow 'way beyond' impact of IRA
Teva CEO Richard Francis said he expects sales growth to continue for the company’s top-selling drug Austedo, even after it becomes subject to new prices negotiated under the Inflation Reduction Act....
View ArticleExclusive: Fertility startup to begin Phase 3 study of stem cell therapy for IVF
Fertility startup Gameto has received permission from the FDA to see if its ovary-in-a-dish technology can make in vitro fertilization a less grueling process, the company told Endpoints News in an...
View ArticleInhibikase shelves Parkinson’s asset after Phase 2 flop
Inhibikase Therapeutics is slamming the brakes on its Parkinson’s disease program after the candidate failed to improve symptoms in a mid-stage test in treatment-naïve patients. The biotech’s...
View ArticleSanofi is in the market for M&A, thanks to ‘strong’ balance sheet
Sanofi is likely to increase its M&A this year since it has more cash in its pockets, as the French pharma also monitors China as a possible source of new drug innovation, CFO François Roger ...
View ArticleRoche aims for derisked deals and ruthless portfolio cuts in 2025
Roche’s M&A strategy in the coming year revolves around derisked mechanisms and high unmet needs, CEO Thomas Schinecker said Thursday. And further dealmaking over assets from China-based biotechs...
View ArticleMerck stops another Winrevair study early based on positive results from...
Merck announced Thursday that it prematurely stopped a Phase 3 study of Winrevair, a drug approved last year for a rare form of high blood pressure in the lungs. The Phase 3 HYPERION study looked ...
View Article