Federal court backs FDA approval of Jazz sleep drug competitor
The US District Court for Washington, DC, on Wednesday ruled against Jazz Pharmaceuticals' attempt to undo the FDA's approval of a competing sleep drug from Avadel Pharmaceuticals that uses the same...
View ArticleUCB's anti-tau Alzheimer's program fails Phase 2 primary endpoint, but...
UCB reported Thursday that a Phase 2 study for its anti-tau Alzheimer’s program bepranemab did not meet its primary endpoint. Neither the low dose nor high dose resulted in patients seeing a benefit,...
View ArticleTeva fined €462.6M over Copaxone patent and competition allegations
Generics giant Teva Pharmaceuticals has been hit with another fine related to its blockbuster multiple sclerosis drug Copaxone, this time by the European Commission. Teva will have to pay €462.6...
View ArticleFDA adcomm votes against Lexicon type 1 diabetes and CKD drug
For the second time in five years, an FDA advisory committee voted against endorsing the benefit-risk profile of Lexicon's drug sotagliflozin. The Endocrinologic and Metabolic Drugs Advisory Committee...
View ArticleQ&A with Obesity Society’s CEO as the field prepares for next-gen meds
The race to create the next best medication for obesity is well underway, and the incumbents are doing everything they can to shore up manufacturing, fight the compounders and develop their own...
View ArticleBiogen brings in medical chief as CFO plans retirement; MacroGenics CEO...
→ Michael McDonnell is retiring as CFO of Biogen on Feb. 28, and Chris Viehbacher’s crew has lined up chief accounting officer Robin Kramer as his replacement. Peer Review covered McDonnell’s
View ArticleEssa’s shares tank as it looks for options after abandoning prostate cancer drug
Essa Pharma is exploring “strategic options” as it ends work on its prostate cancer drug that failed a mid-stage test. The company's shares {$EPIX} nosedived by as much as 65% premarket Friday. In a...
View ArticleBaxter pulls IV products out of China to shift supply to the US
Baxter has “suspended commercial activities” of its intravenous products in China to ease supply issues in the US caused by Hurricane Helene, the company told Endpoints News. “The urgent need to...
View ArticleExclusive: Blood stem cell therapy maker Garuda gets new CEO, adds $47M
Garuda Therapeutics has replaced its top leader and reeled in about $47 million to continue funding its blood stem cell therapy work, Endpoints News has learned. The Cambridge, MA-based biotech...
View ArticleFDA removes hold on three CARsgen CAR-T trials; Ono passes on itolizumab
Plus, news about Kymera Therapeutics, Nanoscope, Eupraxia, Alpha Cognition and EyePoint: FDA's decision on CARsgen’s CAR-T therapies: The FDA on Thursday lifted a clinical hold on three of CARsgen...
View ArticleNovo Nordisk claims late-stage MASH victory, continuing GLP-1's expansion
A day after Madrigal Pharmaceuticals impressed investors, Novo Nordisk is looking to steal the spotlight. The Danish drugmaker reported Friday that semaglutide succeeded in a Phase 3 study of patients...
View ArticleHeritage and Apotex to pay $49.1M in price-fixing settlement
Generic drug manufacturers Heritage Pharmaceuticals and Apotex have agreed to pay $49.1 million to settle allegations from nearly all US states that the companies inflated and manipulated drug prices...
View ArticleMaven Clinic cuts 10% of workforce weeks after raising $125M
Maven Clinic laid off 60 people on Monday, Endpoints News has learned. The layoffs at the unicorn health tech startup represented about 10% of its workforce and happened across the organization,...
View ArticleBMS, J&J and AstraZeneca plea with appeals court to overturn drug price...
A panel of three judges on the US Court of Appeals for the Third Circuit didn't offer too many hints at which side it would take as it heard oral arguments on Wednesday from a ...
View ArticleHow RFK Jr. might influence the FDA; Pharma's Q3 highlights; AbbVie's latest...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleCinRx touts positive data from two obesity drug candidates
CinFina Pharma, a subsidiary of the hub-and-spoke biotech CinRx, shared early-stage data for two of its Janssen-licensed obesity candidates at this year’s ObesityWeek. CIN-110, a PYY analog, and...
View ArticleNovo adds to Wegovy’s cardio strength with hospital admissions analysis
SAN ANTONIO — Novo Nordisk’s wildly popular anti-obesity drug Wegovy helped heart disease patients end up in the hospital less often and stay there for shorter durations than those on placebo,...
View ArticleViking oral weight loss drug shows promising Phase 1 data
SAN ANTONIO — Viking Therapeutics' highly anticipated readout of its oral anti-obesity pill showed a placebo-adjusted weight loss of 6.8% after four weeks, sticking the biotech near the front of a...
View ArticleEuropean Commission marks Dec. 6 for Novo-Catalent deal decision
The European Commission has set Dec. 6 as its deadline to decide if Novo Holdings’ multi-billion-dollar acquisition of Catalent passes its antitrust review, according to a notification on its website. ...
View ArticleMASH drug developers chart path forward as more patients use GLP-1s
For years, drug developers working to treat an advanced form of fatty liver disease known as MASH were chasing wide-open terrain. There were no products on the market, millions of potential patients...
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