Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akili, Apyx Medical, Companion Medical, Miracor Medical, Neoteryx, Preceptis Medical, Royal Philips.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunovative, Mirror Biologics, Karuna, Karyopharm, Marker, Myovant, Novaremed, Pharmacyclics, Polynoma, Reneo, Renibus, Santhera.
Mainstay Medical Holdings plc has won U.S. FDA approval for its Reactiv8 implantable neurostimulation device. The company is eyeing a commercial launch of the system in early 2021. The FDA approved Reactiv8 as an aid in managing intractable chronic low back pain associated with multifidus muscle dysfunction in adults who have failed therapy and are not candidates for spine surgery.
Xpovio (selinexor), an oral selective inhibitor of nuclear transport from Karyopharm Therapeutics Inc., of Newton, Mass., received FDA approval today for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Xpovio will be available immediately in the U.S., the company said, and, due to COVID-19 restrictions, the launch will be a virtual one.
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
A second attempt by Nabriva Therapeutics plc to win U.S. approval for the antibiotic Contepo (fosfomycin) has been undone by COVID-19. Manufacturing issues stymied the original NDA. This time, restrictions of FDA staff travel to Europe sunk the venture, leading to a new complete response letter (CRL) for the candidate as a potential treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Altimmune, Basilea, Bio-Thera, Deciphera, Merck, Nabriva, Regeneron, Resverlogix, Sanofi.