FDA says it explained issues early on for Corcept's rejected Cushing's...
An FDA rejection letter for Corcept Therapeutics’ potential hormonal disorder drug says the agency told the company it had serious concerns before the application was submitted. The complete response...
View ArticleBig Pharma earnings kick off; Third-round IRA drugs selected; Hengrui’s...
Welcome back to Endpoints Weekly! Fourth-quarter earnings season is in full swing, and our team covered reports this week from Teva, Roche, Sanofi, Takeda and Regeneron. CMS also unveiled the next 15...
View ArticleEuropean law changes mean drugmakers may have to grapple with generic...
European regulators will soon sign in a new raft of laws that could make drugmakers jump through more hoops to delay generic and biosimilar competition. And companies developing rare disease and orphan...
View ArticlePharming’s immunodeficiency drug gets CRL for use in younger patients
The FDA has issued a complete response letter to Pharming, rejecting its attempt to expand the approval of its drug for a rare form of immunodeficiency into younger patients. Joenja was
View ArticleSanofi’s venglustat succeeds in Phase 3 Gaucher trial but fails separate...
Sanofi’s investigational drug, with a track record of mixed results in the clinic, has passed a Phase 3 trial in Gaucher disease, but flunked a separate late-stage study in Fabry disease.
View ArticleSanegeneBio licenses RNAi candidate to Genentech for $200M upfront
Genentech will pick up an RNAi candidate from SanegeneBio, a China and US biotech fresh off a $110 million Series B. The Roche unit will pay $200 million upfront for the global ...
View ArticleFDA opens submissions for PreCheck program to speed up US factory builds
The FDA has started accepting pitches for drugmakers to participate in the agency’s PreCheck program, a new initiative aimed to speed up the construction of US manufacturing sites. The agency
View ArticleFDA rejects Aquestive's allergy drug over packaging issues
The FDA has delivered a complete response letter to Aquestive Therapeutics for its allergy medication due to issues over the drug’s packaging. The agency declined to approve Aquestive’s allergy patch...
View ArticleKyowa Kirin reveals side effect in trial; GSK was lone bidder for RAPT
Plus, news on AstraZeneca, Johnson & Johnson, Averin Capital and Chugai: 🧪 Kyowa Kirin discloses side effect for recently regained drug: A patient participating in a Phase 3 trial to treat eczema...
View ArticleSpring Health acquires Alma, expanding insurance reach in virtual mental health
Spring Health is the latest virtual mental health company to lean into insurance as it acquires competitor Alma. The deal, announced Thursday, would give Spring, which has traditionally focused on...
View ArticleGSK returns rights to Wave's RNA editing program for AATD
GSK no longer plans to collaborate on a closely-watched RNA editing program from Wave Life Sciences, whose fate could influence the prospects of the emerging field. Wave announced Monday that GSK ...
View ArticleNew CagriSema data show improvement over semaglutide
Novo Nordisk’s next-gen metabolic drug CagriSema performed better than the blockbuster semaglutide at reducing blood sugar and weight in patients with type 2 diabetes. That was the topline result from...
View ArticleFirst 10 Medicare-negotiated drug prices have taken effect: Are seniors...
The first 10 drugs that underwent government price negotiations in 2023 were projected to save the government billions of dollars. Now, one month since the new pricing took effect, the extent to which...
View ArticleCarbon Health files for bankruptcy, seeking to sell or restructure
Carbon Health has filed for bankruptcy protection and is seeking to restructure or sell itself, the urgent and primary care startup said Monday. The company voluntarily filed for Chapter 11 in the US...
View ArticleMenlo and a16z back AI scientist startup Phylo
Within days of defending their PhDs last year, two Stanford University researchers incorporated their own startup, betting they could build a business around their AI system that handles scientific...
View ArticleAstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo
The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval...
View ArticleUpdated: Do Pfizer’s monthly GLP-1 data justify Metsera’s $10B price tag?
Pfizer said Tuesday that the monthly injection that was one of the cornerstones of its $10 billion buyout of Metsera allowed obesity patients to lose up to 10.5% of their weight, on ...
View ArticlePfizer takes $4.4B charge related to cancer drug in fourth-quarter earnings
Pfizer took a write-down on one of its recent high-profile acquisitions while reporting a positive readout from another. The pharma giant said on Tuesday it took a $4.4 billion impairment charge...
View ArticleUltragenyx unwraps data that may be central to its gene therapy resubmission
Ultragenyx outlined new data on Tuesday that it hopes will convince the FDA to approve its recently resubmitted rare disease gene therapy. Among 17 patients with Sanfilippo syndrome type A who received...
View ArticleDaiichi ends work on an ADC; Layoffs at GSK's R&D unit
Plus, news about Acadia Pharmaceuticals, Eli Lilly, PepLib Biotech, MeiraGTx, ZipBio, Santé Ventures, Adlai Nortye, NMD Pharma, Eton Pharmaceuticals, vTv Therapeutics and Newsoara: ✂️ Daiichi Sankyo...
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