The agreement between gout player Horizon plc and RNAi expert Arrowhead Pharmaceuticals Inc. could result in a subcutaneously given, infrequently dosed fix for the disease that takes aim at xanthine dehydrogenase. “They brought us the target – it wasn’t something we were developing,” said Arrowhead CEO Christopher Anzalone, but the Pasadena, Calif.-based firm’s research on hepatocyte-directed therapies provides confidence. Read More
Shares of Vir Biotechnology Inc. (NASDAQ:VIR) and Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) each rose modestly on June 21 as both delivered positive updates on their COVID-19 programs. Vir and its partner, Glaxosmithkline plc, shared final clinical data confirming the efficacy of their monoclonal antibody therapy, sotrovimab, following an FDA emergency use authorization for the therapy last month. Cumberland announced five case studies in which its antibiotic, Vibativ (telavancin), successfully treated hospital-acquired and ventilator-associated bacterial pneumonia in COVID-19 patients. Read More
PERTH, Australia – Immutep Ltd. announced a AU$60 million (US$45.1 million) capital raise via two tranches to progress two clinical programs of its lead immunotherapy, eftilagimod alpha, to registration studies. Read More
In a split decision delivered June 21, the U.S. Supreme Court resolved the dilemma created by the constitutional non-reviewability of decisions rendered by the Patent Trial and Appeal Board (PTAB). The Supreme Court’s solution is to make those PTAB decisions reviewable by the director of the Patent and Trademark Office (PTO), although the PTO director’s discretion regarding which PTAB cases should be reviewed may itself prove highly controversial in the months and years to come. Read More
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market. Read More
In denying cert to Abbvie Inc. v. FTC June 21, the U.S. Supreme Court may have strengthened an FTC tool for going after biopharma companies that try to protect their patents. The high court’s refusal to hear the case reinforces a September decision by the U.S. Court of Appeals for the Third Circuit that the biopharma industry has said will make it more difficult for drug companies to pursue patent infringement cases in keeping with Hatch-Waxman. Read More
Tarsus Pharmaceuticals Inc. announced results from a pivotal trial of its therapy for Demodex blepharitis, which could lead to an FDA filing to treat the common eye disease for which there are no FDA-approved medications. Read More
Jacobio Pharmaceuticals Group Co. Ltd. has received a milestone payment of $20 million from Abbvie Inc. for dosing the first two patients in the U.S. for a global phase I/IIa study of SHP2 inhibitor JAB-3312 in combination with PD-1 antibody pembrolizumab and MEK inhibitor binimetinib, taking another step forward in the global SHP2 race. Read More
Biopharmas raising money in public or private financings, including: Biophytis, Celsion, Elevation, GH Research, Inhibikase, Kempharm, Monte Rosa, Protagonist, Rapt. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Merck, Orphazyme, Sanofi. Read More
