Now that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals unit, has won the FDA’s nod for Ponvory (ponesimod), market factors will decide how the once-daily oral selective sphingosine-1-phosphate receptor 1 modulator fares against several others already approved in the class. Read More
Barely five and a half years since the company was founded, Kiniksa Pharmaceuticals Ltd. has moved its first drug over the finish line, winning FDA approval for interleukin-1 blocker (IL-1) rilonacept to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 and older. Read More
Following a missed primary endpoint in its phase III study in treating anti-PD-1-refractory advanced melanoma, Idera Pharmaceuticals Inc. is considering stopping the registrational trial of its synthetic Toll-like receptor 9 (TLR9) agonist or pressing on toward the clinical trial’s second primary endpoint. Read More
HONG KONG – Otsuka Pharmaceutical Co. Ltd. is celebrating its 100th anniversary by inking a collaboration and licensing agreement with Perception Neuroscience LLC to develop and commercialize the latter’s PCN-101 (r-ketamine) in Japan. The treatment targets mood disorders such as major depressive disorder and treatment-resistant depression. Perception is also developing PCN-101 to treat TRD outside Japan. Read More
Researchers at the University of California at San Diego have used a gene therapy approach to treat pain by specifically suppressing the Nav 1.7 ion channel in the spinal cord, both preventing and reversing pain in several animal models with distinct underlying reasons for pain. Read More
CAJICA, Colombia – Countries in Latin America have joined those in Europe expressing mixed reactions about continuing their vaccination plans with the AZD-1222 SARS-CoV-2 vaccine developed by Astrazeneca plc and the University of Oxford, following reports of alleged adverse events. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amyndas, Bluesky, Clovis, Eisai, Idera, Incyte, Merck & Co., Sarepta. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Hua, Oramed, Premas, RDIF, Revive, Strides, Vtv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Idorsia, J&J, Kiniksa, RDIF. Read More
