News

Shire plc announced that the U.S. FDA has granted Breakthrough Therapy Designation for two investigational products for rare diseases: SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2...

Company will pursue an indication for the drug in treatment of Duchenne Muscular Dystrophy.Mallinckrodt plc a leading global specialty biopharmaceutical company, announced it has submitted an Investigational New Drug (IND) application for Synacthen® Depot to the U.S. Food and...

Pfizer Inc announced the publication of findings from the Phase 3 INO-VATE ALL study in the online issue of The New England Journal of Medicine. The study, also known as Study 1022, is an open-label, randomized,...

Ironwood Pharmaceuticals, Inc.and Allergan plc announced that the U.S. FDA has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC)....

Ultragenyx Pharmaceutical Inc. a biopharmaceutical company focused on the development of novel productsfor rare and ultra-rare genetic diseases, and Takeda Pharmaceutical Company Limited announced a strategic partnership to develop and commercialize therapies to treat rare genetic diseases. ...

• Existing biopharma venture fund renamed and expanded to all Merck business sectors• Newly established teams will focus on each of the three existing Merck business sectors as well as new businesses• Total fund size doubled to up to...

In ENESTfreedom, 51.6% of eligible first-line Tasigna patients maintained TFR for 48 weeks after stopping treatment; study did not meet its statistical primary endpoint, specifically the > 50% lower limit of the 95% confidence interval ENESTop...