The FDA Thursday approved Mylan NV’s Semglee (insulin glargine), adding another player to the U.S. insulin space that has been pretty much controlled by three companies – Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA.
Due to the pressing challenges of COVID-19, Health Canada is giving drug companies six more months to prepare for major reforms to its 1987 Patented Medicines Regulations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biophytis, BMS, CNS, Diffusion, Eyegate, Genequantum, Inmune, Intelgenx, Lannett, Leo, Mylan, Novartis, Pfizer.
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bacainn, Curis, F2G, Fulcrum, Pharnext, Redhill, Rezolute, Vertex.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Global Blood Therapeutics, Immune, Immunic, Immuron, Revive, Saniona.
The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Arch, Cassi, Cytodyn, Enochian, Heat, Helsinn, Insmed, Kiniksa, Lupin, Sound, Taiho.
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