FDA rejects Atara's cell therapy for rare transplant complication, stock craters
US regulators have rejected a T cell therapy for a rare and serious transplant complication related to Epstein-Barr virus from Atara Biotherapeutics and Pierre Fabre. The therapy, known as...
View ArticleDenmark’s new manufacturing learning center; Telix buys facility, assets and...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Novo Nordisk is investing DKK 120 million ($16.5 million) into...
View ArticleBoehringer's schizophrenia asset fails Phase 3; GSK buys organoid biotech
Plus, news about Kodiak Sciences, Outlook Therapeutics and Avacta: Boehringer Ingelheim reports Phase 3 schizophrenia fail: The drug, iclepertin, did not show any “statistically significant effects on ...
View ArticleBroad Institute paper offers potential new framework for treating...
Most clinical trials for Huntington’s disease have run aground in the last few years, but academic researchers haven’t been dissuaded from trying to shift how the rare genetic disorder is understood. A...
View ArticleNovartis enters fight against HHS for denying its 340B rebate model
Novartis is the latest drugmaker to sue the government for allegedly rejecting its proposed model to distribute federal drug discounts. The lawsuit marks the fifth drugmaker to challenge HHS’s Health...
View ArticleUnitedHealth Group reports higher revenue in first earnings since Brian...
Since the killing of UnitedHealth Group’s top insurance executive and the outpouring of public frustration with delayed and denied care that followed, a major question has circled the healthcare giant:...
View ArticleIs digital health living up to its promise?
A central aspiration of health tech is that technology will make getting care easier and less expensive, allowing for more people (and especially disadvantaged people) to use it. But new research...
View ArticleEMA in 2024 recommended highest number of drug approvals in 15 years
The EMA's human medicines committee recommended 114 medicines for approval in 2024, marking the highest number of positive opinions issued in 15 years, according to the regulator’s latest report. Of...
View ArticleDC appeals court halts launch of generic to Novartis' heart drug
Novartis won a potentially short-lived victory in its fight across multiple courts to keep generic versions of its blockbuster heart drug Entresto off the market. The US Court of Appeals for the DC...
View ArticleShionogi lands $375M from HHS to develop preventive drug for Covid-19
After seeing its Covid-19 drug fail in a Phase 3 trial last year, Shionogi on Thursday won a $375 million award from HHS to develop a preventive drug for the disease. The drug is aimed ...
View ArticleHHS blasts Boehringer's drug price case, reveals new details on Jardiance talks
HHS told the Second Circuit that Boehringer Ingelheim’s voluntary participation in Medicare negotiations “undermines” its legal challenge to the process. Voluntariness was a key factor in the lower...
View ArticleTeva says it has a 'unique position' in latest IRA challenge
Teva is the latest drugmaker to file suit against Medicare negotiations. But unlike other companies that have challenged the inclusion of their drugs in negotiations, Teva says its case is unique. The...
View ArticleDeparting FDA commissioner: 'We're losing the battle on misinformation'
Rob Califf officially ends his tenure as FDA commissioner on Monday, but in his final media event, he stressed that the US is still struggling to fight misinformation online. "I'm afraid that my...
View ArticleRoche's cardiometabolic chief warns against weight loss 'obsession' with GLP-1s
The rise of GLP-1s has made treating obesity one of the largest market opportunities in history. It also has reinforced a detrimental relationship between physical health and size, according to one...
View ArticleAmgen’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...
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