Johnson & Johnson’s once-daily oral selective sphingosine-1-phosphate receptor 1 modulator Ponvory (ponesimod) won FDA clearance for adults with relapsing forms of multiple sclerosis. The label includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Ponvory will face off with market leader Gilenya (fingolimod, Novartis AG), which posted 2019 sales of $3.2 billion and two other drugs in the class.

Kiniksa reaches commercial stage with first FDA-approved drug for recurrent pericarditis

Barely five and a half years since the company was founded, Kiniksa Pharmaceuticals Inc. has moved its first drug over the finish line, winning FDA approval for interleukin-1 blocker (IL-1) rilonacept in recurrent pericarditis. It marks the first FDA nod for the rare autoinflammatory cardiovascular disease characterized by recurring inflammation of the pericardium that limits patients’ physical activity and reduces quality of life.

At the crossroads: Idera ponders TLR phase III continuation

Following a missed primary endpoint in its phase III study in treating anti-PD-1-refractory advanced melanoma, Idera Pharmaceuticals Inc. is considering whether to stop the registrational trial of its synthetic Toll-like receptor 9 agonist or press on toward the second primary endpoint. The Illuminate-301 study of tilsotolimod in combination with ipilimumab vs. ipilimumab alone missed the objective response rate endpoint but the overall survival endpoint remains. Whatever the decision, Idera said its phase II study of tilsotolimod in combination with ipilimumab and nivolumab for treating microsatellite stable colorectal cancer will keep moving ahead. The Exton, Pa.-based company stock (NASDAQ:IDRA) struggled mightily at midday with shares trading 63% lower.

Otsuka hopes to change Perception on depression with partnership for r-ketamine PCN-101

HONG KONG – Otsuka Pharmaceutical Co., Ltd. is celebrating its 100th anniversary by inking a collaboration and licensing agreement with Perception Neuroscience 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. The agreement gives Otsuka the exclusive rights to develop and commercialize products containing PCN-101 in Japan. It will also undertake development, regulatory, and commercialization activities in the country. Perception will rake in an up-front payment of $20 million, which it plans to use to fund its overall development of treatments. The company will also be eligible to receive development, regulatory and commercial milestones, as well as tiered, double-digit royalties on future sales.

Startup Navega tests gene therapy for pain syndromes

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. The work was published in the March 10, 2021, issue of Science Translational Medicine. First author Ana Moreno and senior author Prashant Mali are two of the co-founders of startup Navega Therapeutics Inc., which is working to bring the approach into the clinic and hopefully, from there, to the market.  

Mixed decisions about Astrazeneca’s SARS-CoV-2 vaccine in Latin America

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.

Also in the news

Amyndas, Bluesky Immunotherapies, Bristol Myers Squibb, Clovis Oncology, Connect, Eli Lilly, Finch, Hua, Idera, Idorsia, Incyte, Instil, J&J, Kiniksa, Merck, Oramed, Oravax Medical, Premas, RDIF, Revive, Sarepta, Solid, Vtv, X4