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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABM, Achilles, Bioinvent, Fibrogen, Kadmon, Myovant, Oncolytics, Oppilan, Principio, Reneo, Seelos, Sunesis, Vaccitech.
Makers of devices for ablation for atrial fibrillation (AF) have struggled at times to overcome clinician skepticism, but a new report in a respected medical journal might persuade some of those cardiologists. A study of nearly 28,000 AF patients in South Korea demonstrated that device therapy yielded lower rates of death and admission for heart failure compared to medical therapy, suggesting that ablation is a valid alternative to medical therapy, at least for patients in Asia.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.
A new U.K. trial evaluating drugs for hospitalized patients in the early stages of COVID-19 has elected to test Evelo Biosciences Inc.'s anti-inflammatory monoclonal microbial, EDP-1815, after an earlier trial found it led to favorable anti-inflammatory activity in psoriasis patients.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Conformis, Mainstay Medical, Medtronic, Omnipathology.
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.”
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