The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.
The U.S. Food and Drug Administration approved Phathom Pharmaceuticals Inc.’s Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules) for the treatment of Helicobacter pylori infection in adults.
Two strategic biopharmaceutical collaborations were announced, each merging one company’s innovative biologic technology with a second company that can drive potential therapeutics over the finish line to commercialization.
Temps are falling and so is investor cash as BioSpace reviewed which biotech companies are scooping up the dollars.
J&J’s Janssen Pharmaceutical ended a collaboration with San Francisco’s Theravance Biopharma after a disappointing performance from a drug the two companies were developing together.
Lilly announced that mirikizumab, the company’s monoclonal antibody formulation to treat ulcerative colitis (UC), met the primary endpoint of clinical remission and all key secondary endpoints at one year in a Phase III maintenance study.
Florida-based AzurRx BioPharma is bolstering the company’s gastrointestinal disease pipeline with the $229 million acquisition of First Wave Bio and its small molecule therapeutics for auto-immune inflammatory bowel diseases (IBD) and other serious conditions.
Phathom Pharmaceuticals Inc. submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori infection in adults.
CytoReason and Ferring Pharmaceuticals announced a collaboration that pairs CytoReason’s artificial intelligence (AI)-based computational model of the human body with Ferring’s expertise in inflammatory bowel disease (IBD). The purpose is to develop cell-based disease models to accelerate drug discovery and reduce development costs.
A little more than one year after Gilead Sciences Inc. and Galapagos NV announced intentions to seek regulatory approval for Jyseleca (filgotinib) as a treatment for rheumatoid arthritis, the companies pulled the plug on that goal as well as others following a Complete Response Letter issued in August 2020.
