The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Cycle, Essa, Gan & Lee, Gannex, Kiadis, Mateon, Novartis, Pharmacyte, Regeneron, Reven, Sanofi, SK, Seneca, Supernus, Vaxart, Vertex, Ziopharm.
LONDON – With just four months to go until Brexit is activated, the start of September finally saw the med-tech industry get official guidance on the licensing regime for medical devices in the U.K. once the Medicines and Healthcare Products Agency (MHRA) becomes the standalone regulator Jan. 1, 2021.
PARIS – For the past three years, French health care establishments, hospitals, radiotherapy centers and medical biology laboratories have had to report any security incidents affecting their IT systems. The French national agency for digital health care (ANS) has just released its latest annual report.
Avinger Inc. has received U.S. FDA clearance for a its Ocelaris next-generation, image-guided chronic total occlusion (CTO) crossing system for patients with peripheral artery disease (PAD). The catheter-based system, which will be sold under the brand name Tigereye, provides real-time imaging from within the vessel during a CTO-crossing procedure. It will be available on a limited basis beginning later this year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cardio-Phoenix.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Immupharma, Junshi, Seres, Sol-Gel.
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