FDA approves Sanofi's RNAi drug for hemophilia A and B
The FDA on Friday said it approved a new RNAi-based hemophilia treatment from Sanofi that the company licensed from Alnylam. Patients with hemophilia A or B will now be able to ...
View ArticleNovartis’ radiopharma drug Pluvicto gets an expanded label
Novartis’ prostate cancer radiopharmaceutical Pluvicto has netted a highly anticipated and highly delayed expanded indication. The FDA on Friday approved the drug for certain patients before they have...
View ArticleAmgen loses challenge to Colorado drug review board
A federal judge on Friday dismissed Amgen’s lawsuit against Colorado's drug affordability board and its call for a price cap on the company's blockbuster autoimmune drug. District Judge Nina Wang...
View ArticleBluebird gets new M&A bid, seeking to top private equity offer
A rival group is seeking to buy cell therapy biotech bluebird bio, in an effort to outbid a private equity offer by Carlyle and SK Capital, the company confirmed on Friday afternoon. The rival buying ...
View ArticleLykos’ interim CEO is set to step down
Lykos Therapeutics’ interim CEO Michael Mullette is planning to step down, according to a source familiar with the decision. Mullette relayed the move to staff in February, saying that he would stay on...
View ArticleCOVID research cuts target work on antivirals and vaccines to prevent future...
On Tuesday, drug discoverer and biotech entrepreneur Alpha Lee told scientists at a chemistry meeting about a new molecule to combat the Zika virus. There are no treatments designed to stop the...
View ArticleFDA's Peter Marks resigns, in disagreement with Kennedy
Peter Marks, the head of the FDA's Center for Biologics Evaluation and Research and one of the agency's highest-profile officials, has suddenly resigned amid a simmering disagreement with the Trump...
View ArticleHHS cuts and more from DC; Lyndra winds down; 23andMe files for bankruptcy;...
Welcome back to Endpoints Weekly, where we recap the week’s biggest news from the biopharma industry. Let’s start in DC. The Senate confirmed nominations this week for Johns Hopkins researcher Marty...
View ArticleLilly's heart drug study shows potential for once-a-year dosing
Phase 2 results on Eli Lilly’s experimental heart disease drug showed it could be dosed far less frequently than competing treatments in development from Novartis and Amgen, giving Lilly a way into an...
View ArticleBiotech markets fall as industry takes stock of Marks' exit at FDA
The departure of one of the FDA’s highest-profile regulators, whose career was defined by advancing new technologies to patients, rattled investors and companies who were already feeling insecure....
View ArticleAstraZeneca’s cholesterol pill is set for Phase 3, but lags behind Merck rival
AstraZeneca has great ambitions for its mid-stage oral cholesterol drug, believing that it could reach peak sales of more than $5 billion. Positive data presented Monday at the American College of...
View ArticleMerck’s PAH drug slashed risk of serious events in halted trial
New data unveiled Monday showed that Merck’s Winrevair can significantly cut the risk of death, lung transplantation and hospitalization in patients with a rare form of high blood pressure in the ...
View ArticleCorcept shares soar after Phase 3 win in ovarian cancer
Corcept Therapeutics’ oral glucocorticoid receptor antagonist has improved survival outcomes in a late-stage test in patients with a challenging form of ovarian cancer, sending its shares up 76% at...
View ArticleVaxcyte's Phase 2 pneumococcal vaccine data disappoint investors
Vaxcyte’s stock price {$PCVX} dropped by 50% on Monday after the company reported new Phase 2 data from a study evaluating an experimental pneumococcal vaccine in infants. The company said VAX-24 was...
View ArticleFDA reschedules opioid-focused advisory meeting
A meeting of outside experts to discuss the FDA’s post-marketing requirements for opioid medications is now slated for May 5 after being postponed earlier this year. The meeting — originally scheduled...
View ArticleHeart gene therapy company Tenaya to lay off 30% to 40% of staff
Heart gene therapy maker Tenaya Therapeutics is laying off 30% to 40% of its staff by the end of the year, the company’s CEO Faraz Ali told Endpoints News by email. Tenaya had 97 employees ...
View ArticleFDA changes may not be over after Marks exit, with more cuts and departures
A top official pushed out over vaccines. Senior staff heading for the exit. Thousands of workers targeted for firing. A new commissioner who has yet to visibly take charge ...
View ArticleDC court sides with HHS in Vertex's fertility program fight
Vertex lost a legal battle against the federal government on Monday over its proposed fertility support program that would have offered up to $70,000 in services for certain gene therapy patients. A DC...
View ArticleFederal judge nixes FDA's lab-developed test rule
The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s regulation, a Texas federal court held on Monday. The decision is a ...
View ArticleUpdated: J&J’s third talc bankruptcy bid is stopped by Texas federal judge
A federal judge on Monday dismissed a Johnson & Johnson subsidiary’s third attempt to settle tens of thousands of talc cases through bankruptcy. Judge Christopher Lopez cited multiple issues with...
View Article