The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Medicare & Medicaid Services, HHS.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fluidigm, Inova, Jointechlabs, Natera, Surgentec.
The latest global regulatory news, changes and updates affecting biopharma, including: Apotex, Auspex, Glenmark, Johnson & Johnson, Sandoz, Teva, Taro.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3Sbio, Alimera, Hansa, Hifibio, Catalyst, Kye, Revive, TLC.
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Health and Human Services, Drug Enforcement Administration, FDA, Health Canada, National Center for Advancing Translational Sciences, SK Biopharma.
HONG KONG – Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B. Braun, Gyroscope, Philips, Sientra.
DUBLIN – Ipsen SA is on track for an NDA filing for palovarotene in fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease characterized by the gradual replacement of skeletal muscle and connective tissue with bone, following an interim analysis of phase III data which indicates that the drug may have a substantial effect on the disease process.
The idea of patent pools such as the COVID-19 Technology Access Pool (C-TAP) created by the World Health Organization a few months ago has drawn a lot of support from low- and middle-income countries and a handful of wealthier ones, but not so much from industry.
RSS
