Vanda loses constitutional fight over FDA's drug talks with competitors
The FDA dodged claims from Vanda Pharmaceuticals that it allegedly violated the US Constitution by recommending the same drug specifications for both Vanda and its generic competitors. The opinion,...
View ArticleAstraZeneca exec stresses Calquence's patent life ahead of next Medicare...
AstraZeneca says it plans to participate in the next round of Medicare negotiations under the Inflation Reduction Act. But this time around, the company says it’s dealing with a whole different set of...
View ArticleTeva’s MS drug and generics to add black box warning for anaphylaxis
The FDA has issued a new boxed warning for Teva Pharmaceuticals' multiple sclerosis drug Copaxone and generic versions marketed by other companies after some patients had serious allergic reactions....
View ArticleAnthos' detailed mid-stage data back its anticoagulant, but can the drug...
Anthos Therapeutics’ anticoagulant poses a lower risk of bleeding events than Bayer and J&J’s Xarelto when used to prevent blood clots in atrial fibrillation patients, full results from a mid-stage...
View ArticleBioMarin's James Sabry talks biotech M&A, dealmaking in 2025
SAN FRANCISCO — Not many biotechs survive beyond 25 years, let alone get multiple drugs approved and turn a profit. BioMarin Pharmaceutical has done all that, but finds itself navigating an unusual...
View ArticleHealth Tech startup Innovaccer lays out its acquisition strategy
Innovaccer is buying up health tech companies with the goal of providing healthcare organizations with a simple place to go for a number of tools. The Silicon Valley-based startup sells tools to...
View ArticleFDA delays decision on Stealth’s Barth syndrome drug; TargetRx raises $50M
Plus, news about Valneva and Ab&B Bio-Tech: FDA delays decision on Stealth BioTherapeutics drug to April 29: The company’s elamipretide is being developed for Barth syndrome, a rare genetic...
View ArticleAbbVie partners with Neomorph in latest molecular glue deal
Neomorph is back at it again with another pharma collaboration. The startup, which is backed by Deerfield Management and the Dana-Farber Cancer Institute, secured another partnership for its molecular...
View ArticleWhat health tech wants from a Trump administration
We’re in the first week of the second Trump administration, and it’s becoming clearer how it might impact healthcare technology. Notably, President Donald Trump revoked the Biden Administration’s AI
View ArticleCatalent to make CAR-T for Galapagos; Kindeva gets $129M for nerve agent...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Catalent said it will manufacture Galapagos’ clinical-stage CAR T...
View ArticlePurdue, Sacklers reach new $7.4B opioid settlement after SCOTUS rejection
Purdue Pharma and the Sackler family have agreed to a $7.4 billion settlement in a longstanding legal battle over the nation’s opioid epidemic. The deal, announced Thursday, comes months after the...
View ArticleTeva, Astellas plan to participate in IRA drug price negotiations
At least three drugmakers say they will participate in the next round of Medicare negotiations under the Inflation Reduction Act, even though they continue to criticize the process as “price setting.”...
View ArticleAs another Trump term gets underway, pharma advisors get comfortable with...
What will President Donald Trump's team do on healthcare? Nobody knows for sure. That was the general agreement among the policy experts who advise the drug industry last week at the JP Morgan...
View ArticleUnitedHealth Group names Tim Noel as next insurance CEO
UnitedHealth Group has named a new CEO to lead its health insurance business, following the murder of the division’s former top executive in December. The role will be filled by Tim Noel, a company...
View ArticleObesity biotech Aardvark files for IPO to advance oral drug
Aardvark Therapeutics filed for an IPO Thursday night, making it the sixth biotech in line this year for a potential listing on the Nasdaq. The San Diego biotech is trying to ...
View ArticleALX Oncology to make case for accelerated approval with evorpacept in gastric...
ALX Oncology is forging ahead with a treatment approach that has long been abandoned by other drugmakers, eyeing a potential accelerated approval pathway for its CD47-targeting drug in gastric cancer...
View ArticleModerna information chief to retire next month; Pharming looks to Flagship...
Moderna’s chief information officer Brad Miller is “retiring” in February, a company spokesperson confirmed to Endpoints News. His roughly two-year stint followed more than five years in top executive...
View ArticleNovo Nordisk’s amycretin prompts 22% weight loss in early obesity trial
Novo Nordisk’s subcutaneous form of amycretin achieved estimated weight loss of 22% at six months in a Phase 1b/2a clinical trial, the Danish company said Friday. The data are highly competitive ...
View ArticleAstraZeneca allocates $570M for Canadian expansion, looks to add 700 new jobs
AstraZeneca is looking to increase its presence north of the US border. The UK pharma said it is budgeting $570 million to expand its footprint in Canada, which will help create more than 700 new ...
View ArticleBoehringer merges cancer vaccine and oncolytic virus teams; Dantari sells off...
Plus, news about Madrona and Abdera: Boehringer Ingelheim combines two cancer units: The drugmaker is merging its cancer vaccine unit AMAL Therapeutics and its oncolytic virus team ViraTherapeutics,...
View Article