Amgen’s KRAS drug Lumakras clinches FDA green light in colorectal cancer
Amgen’s Lumakras has secured an FDA approval in combination with the drugmaker’s Vectibix for a subset of patients with metastatic colorectal cancer, marking a positive change for the selective KRAS...
View ArticleKathy High leads GV, ARCH-backed eye disease biotech; Arvinas commercial exec...
→ Spark co-founder Kathy High made a quiet return to eye disease drug development, becoming CEO of US-Swiss biotech RhyGaze “late last year,” the Philadelphia Business Journal reported this week....
View ArticleAstraZeneca wins BTK race to market in first-line mantle cell lymphoma
AstraZeneca’s Calquence became the first BTK inhibitor approved in the US for first-line use in mantle cell lymphoma on Thursday. The drug may now be used in combination with chemoimmunotherapy in ...
View ArticleOzempic makes list for next Medicare negotiation round
Novo Nordisk’s blockbuster GLP-1 products Ozempic and Wegovy are among the next 15 drugs subject to the government’s Medicare negotiation program under the Inflation Reduction Act, following repeated...
View ArticleNovo claims high-dose Phase 3 Wegovy win but sales impact might be muted
Following the poorer-than-hoped performance of CagriSema last month, Novo Nordisk needed an emphatic clinical success with its high-dose version of Wegovy. The obesity drug did not quite manage one. A...
View ArticleWuXi AppTec sells medical device testing unit; Layoffs at Notch Therapeutics
Plus, news about Neurizon: WuXi AppTec divests again: The company is selling its US medical device testing operations, including facilities in Minnesota and Georgia to medtech consulting firm NAMSA,...
View ArticleWhat Trump's CMS can and can't change with the second round of drug price...
CMS didn't wait for President-elect Donald Trump to take office before issuing its second list of drugs to be negotiated under the Inflation Reduction Act, even though the agency had until Feb. 1 to...
View ArticleFDA approves AstraZeneca and Daiichi Sankyo’s ADC for breast cancer despite...
The FDA on Friday approved datopotamab deruxtecan, an antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, for a subset of patients with the most common form of breast cancer, despite...
View ArticleSage sues Biogen days after $469M buyout offer
Sage Therapeutics has sued Biogen in Delaware court, one week after receiving a $469 million buyout offer from the larger neuroscience pharma company. The full lawsuit was sealed, and the court said...
View ArticleJPM's M&A Monday frenzy; Ozempic selected for IRA negotiations; Pfizer says...
Welcome back to the new and improved Endpoints Weekly! This week we’ll be recapping the JP Morgan Healthcare Conference, IRA price negotiations, Pfizer’s plans to get back on track, and more. Thanks to...
View ArticleAnother US biotech emerges with drug candidate from China-based Keymed
The China-to-US experimental medicine pipeline is ballooning: yet another US-based biotech formed around a candidate from China's Keymed Biosciences on Monday. Life sciences investment firm RTW has set...
View ArticleSionna and Odyssey end JPM week with IPO filings
Sionna Therapeutics and Odyssey Therapeutics have joined Metsera and Maze in an attempt to go public via the still-rocky IPO route. The biotechs, focused on cystic fibrosis and immunology,...
View ArticleExiting Medicare director expects current law to guide next price negotiations
Meena Seshamani believes the landmark Inflation Reduction Act will “lay the foundation” for future drug price negotiations under the new Trump administration. Seshamani, the former Medicare director...
View ArticleWith support from NFL owner Jeffrey Lurie, Icelandic biotech closes Series A...
A father-and-son biotech with ties to Iceland and Philadelphia has put together a €26.5 million Series A to develop oral treatments for Alzheimer’s disease and other neurodegenerative conditions....
View ArticleAscentage estimates $133M in proceeds as it plans dual listing
Ascentage Pharma's plans for a dual listing in the US could load its coffers with about $133 million in net proceeds, the commercial drugmaker said in a Tuesday SEC filing. ...
View ArticleFDA puts Atara’s INDs on hold after rejection; Ascletis' safety data for...
Plus, news about Amylyx and Sanofi: FDA places hold on Atara Biotherapeutics’ active INDs: The holds affect the T cell therapy that the agency rejected last week as well as another program called...
View ArticleChina's drug development explosion forces a US biotech reckoning
In 2019, Stanford University professor Irv Weissman and a colleague published a paper that represented a new way to target some aggressive cancers. Shortly after, they did what many researchers do when...
View ArticleWhat to make of UnitedHealth Group’s rebate move
In its first earnings since the murder of UnitedHealthcare CEO Brian Thompson, UnitedHealth Group made a move that caught industry insiders’ attention. The healthcare giant said its pharmacy benefit...
View ArticleSanofi says no supply interruptions after landing FDA warning letter for US site
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in Massachusetts. The letter, published on Tuesday, was handed to Sanofi on ...
View ArticleJ&J's Spravato wins expanded label for depression as singular treatment
Johnson & Johnson’s Spravato nasal spray received a label expansion on Tuesday, now approved as a standalone treatment for major depressive disorder in adults after two oral antidepressants fail,...
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