FDA warns EyePoint over eye implant manufacturing woes
The FDA has sent EyePoint Pharmaceuticals a warning letter after uncovering manufacturing issues with the company’s eye implant Yutiq. The letter, issued July 12 and published Tuesday, said FDA...
View ArticleSanofi pauses supply of two flu vaccines in China over ‘unexpected...
Sanofi is halting distribution of its two approved flu shots in China due to low potency, and says it won’t meet supply expectations for the products there this flu season. After what it called a...
View ArticleHouse Oversight chair tells PBM CEOs to correct testimonies from July hearing
House Oversight Chair James Comer (R-KY) has told the CEOs of the three major PBMs — CVS Caremark, Express Scripts and Optum Rx — to correct what he’s claiming are contradictions in their statements...
View ArticleRegeneron sues Sandoz to halt biosimilar to its blockbuster eye drug
Regeneron is going after Sandoz in a New Jersey federal court over Sandoz’s recently-approved drug Enzeevu, a biosimilar to Regeneron’s blockbuster eye treatment Eylea. Eylea, which has collected...
View ArticleDelaware high court to review expert testimony in Zantac suits, in win for...
Ten of the plaintiff-chosen experts expected to testify in litigation over whether the heartburn drug Zantac caused cancer will be reviewed by the Delaware Supreme Court, raising the possibility that...
View ArticleUK government partners with pharma on new £400M life science infusion
The new UK Labour government is making one of its first major investments in the biopharma ecosystem, establishing 18 new clinical trial hubs in a joint industry collaboration worth up to £400 million...
View ArticleHow an upstart pharmacy benefit manager has been winning over companies like...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) In a market long dominated by three giants, a different kind of pharmacy benefit manager has been...
View ArticleClik here to view.
BioMarin lays off 225 employees as it cuts spending on gene therapy rollout
BioMarin’s decision to scale back its gene therapy ambitions will result in about 225 employees losing their jobs, the biotech disclosed late Wednesday. The layoffs, which are tied to “organizational...
View ArticlePreclinical team hit hardest in Repare's R&D prioritization, layoffs
Repare Therapeutics is cutting its headcount by about 25%, with most of the layoffs concentrated in the company’s preclinical team, as part of what the company is calling a “strategic prioritization”...
View ArticleMerck ends two Phase 3 studies of Keytruda, including an early-stage...
Merck said Thursday morning it is discontinuing two Phase 3 trials of Keytruda, the world’s top-selling medicine, after independent data monitoring committees determined they weren’t going to succeed....
View ArticleJ&J heads to FDA for Vyvgart competitor; Tokyo conglomerate launches venture...
Johnson & Johnson submits FDA application for Vyvgart competitor: The pharma company is seeking approval of nipocalimab in the autoimmune disease generalized myasthenia gravis, where argenx’s...
View ArticleRecursion nears ‘moment of truth’ with first key data, kicking off 18-month...
After years of talking up artificial intelligence’s potential to help make drugs, Recursion will finally bring data to the table — and lots of it. Sometime next month, the Salt Lake City-based biotech...
View ArticleAhead of acquisition by Novo Holdings, are Catalent’s dark days behind it?
In the months leading up to its pending acquisition by Novo Holdings, Catalent has meaningfully boosted its revenue for the first time in over a year, making headway while other contract manufacturers...
View ArticleAfrigen, CEPI to speed up mRNA vaccine manufacturing; Bora Pharma invests in...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The Coalition for Epidemic Preparedness Innovations (CEPI) is...
View ArticleFDA hints at what Chevron's elimination means in new SCOTUS filing
Earlier this summer, when the Supreme Court eliminated a longstanding legal doctrine that deferred to federal agencies on interpreting federal law, many legal observers said the move could spell the...
View ArticlePennsylvania judge sides with drugmakers on first steps for growing GLP-1...
A Pennsylvania federal judge has agreed to prioritize two main arguments at issue in a growing number of lawsuits over the alleged side effects of GLP-1s, a legal decision that developers of the drugs...
View ArticleFDA’s drug evaluation wing launches new AI oversight panel
The FDA is hoping that rapidly-advancing artificial intelligence capabilities will not pass it by. The agency’s Center for Drug Evaluation and Research (CDER) has launched its own AI Council, according...
View ArticleClik here to view.
Updated: Alnylam’s new Phase 3 ATTR data bring uncertainty to standard of...
Alnylam Pharmaceuticals is continuing to make its case for vutrisiran to become the drug of choice for a heart muscle disease, and while the company reported positive results at a major medical meeting...
View ArticleClik here to view.
J&J's human resources leader to retire; Amgen becomes the newest pharma with...
Kristen Mulholland → Kristen Mulholland will take over for the retiring Peter Fasolo as chief human resources officer at J&J on Oct. 1. “Peter has led J&J’s talent strategy for the past 16...
View ArticleClik here to view.
NuCana stops Phase 2 as chemotherapy derivative 'unlikely' to meet primary...
Chemotherapy biotech NuCana’s stock $NCNA tanked nearly 50% in premarket trading Friday following a Thursday announcement that it had stopped a Phase 2 trial due to disappointing data. The company said...
View Article