Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Adial, Ascendis, CSL Behring, Daiichi Sankyo, Esperare Foundation, Gilead, Medivir, Mesoblast, Mylan, Napo, Sinovac, Viiv.
Carag AG received investigational device exemption (IDE) approval from the U.S. FDA for its Carag Bioresorbable Septal Occluder (CBSO). The device is the first transcatheter septal occluder with a nonmetal, bioresorbable framework. The Baar, Switzerland-based company plans a "swift start" for a staged study trial in the U.S. with 250 patients, Carag's CEO Jérôme Bernhard told BioWorld.
CAJICA, Colombia – The Latin American biotech sector is scrambling in the midst of the COVID-19 pandemic, not only in coping with the outbreak, but also in finding the path to the future, while avoiding the pitfalls and looking for new opportunities ahead.
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acacia, Beigene, Biophytis Eusa, Geron, Metvital, Mundipharma, Napp, Rhythm.
The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.
Orthopedic implant startup Engage Surgical has received 510(k) clearance from the FDA for its Engage Partial Knee system, the only cementless partial knee implant available in the U.S. The company is introducing the product via a limited release to select surgical centers.