Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonesupport, Burning Rock Biotech, Establishment Labs.
Pfizer Inc. may have a blockbuster on its hands with the U.S. FDA’s approval of Velsipity (etrasimod), a selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endonovo Therapeutics, Foundation Medicine, Infobionic, Medtronic.
No one is looking in the rearview mirror at Medtronic plc as a fresh U.S. FDA approval for the next generation version of its intrathecal drug delivery system allows the company to leave behind a spate of problems associated with its Sychromed II device. The device delivers medication directly to the fluid surrounding the spinal cord via a small catheter positioned to deposit the drug at the site of most severe pain. The targeted delivery improves management of chronic and cancer-related pain as well as management of severe spasticity without use of systemic opioids.
With an eye on making the U.K. more attractive for clinical trial research, the Medicines and Healthcare products Regulatory Agency took a step Oct. 12 to overhaul its clinical trials regulations by reducing the approval time for the lowest-risk studies.
The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue.
The FDA town hall on the final day of the 2023 edition of the Med Tech Conference included the usual patter about the achievements at the agency’s Center for Devices and Radiological Health (CDRH), but a few useful nuggets of information nonetheless slipped through in this year’s session. CDRH director Jeff Shuren acknowledged that the agency is steering device advisory committee hearings away from votes on whether to approve a product, an approach he said is under consideration at the agency’s other product centers as well.
Responding to the burgeoning field of digital health, the U.S. FDA reported the creation of a new Digital Health Advisory Committee that it expects to be up and running in 2024.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Neoss, Orthofix Medical, Sentiar.
As it continues its crackdown on accelerated approval, the FDA continues to stress that successfully completing confirmatory trials should be the top priority for sponsors of drugs that enter the U.S. market via accelerated approval.
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