The regulator’s approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.
The class of drugs, which includes Novo Nordisk’s Ozempic and Wegovy, are associated with the risk of gastrointestinal adverse events when used for weight loss, finds a study published Thursday in JAMA.
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
In its briefing document for Thursday’s FDA advisory committee meeting, the regulator contends that the company’s confirmatory CodeBreaK 200 trial for Lumakras is not an “adequate and well-controlled” study.
The Japanese pharma is voluntarily withdrawing its lung cancer drug mobocertinib, marketed as Exkivity, from U.S. and global markets after it missed the mark in a Phase III confirmatory trial.
Shares of the biotech startup jumped as much as 70% on Friday after the company reported promising early-stage results for a four-week trial that included only 24 patients.
The biopharma is projecting its HIV business will reach up to $8.5 billion in sales by 2026, based on the success of its long-acting antiretroviral therapy Cabenuva.
The companies, which have been partners for a decade on various research programs, are pooling their efforts in two early-stage programs for Alzheimer’s and Huntington’s diseases using RNA-targeting medicines.
The Italian pharma company is acquiring what was once one of the hottest stocks in the biotech sector, just months after the FDA rejected Intercept’s non-alcoholic steatohepatitis candidate.
The company’s experimental drug for amyotrophic lateral sclerosis reduced the risk of death by 49% compared to the largest U.S. database of previous ALS therapy trials.
The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
The company’s treatment for IgA nephropathy, sparsentan, failed to meet statistical significance by a measure of kidney function in a head-to-head confirmatory study versus irbesartan.
The company has dropped its gene therapy candidate TSHA-120 for giant axonal neuropathy after the FDA reiterated the need for a randomized, double-blind, placebo-controlled trial.
The deal is an expansion of an existing production agreement between the companies and just one of several deals with large pharma companies that the Korean biotech has scooped up this year.
The Swiss pharma’s shareholders on Friday approved spinning off the generics and biosimilars division, with plans to launch at least five additional biologic drugs.
