Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Bayer, Beigene, Bioheng, BMS, Boehringer, Day One, Eli Lilly, Hope Biosciences, Hutchmed, Prestige, Vertex.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo, Medtronic, Onward Therapeutics, Qualimed, Sensome.
In denying cert to Abbvie Inc. v. FTC June 21, the U.S. Supreme Court may have strengthened an FTC tool for going after biopharma companies that try to protect their patents. The high court’s refusal to hear the case reinforces a September decision by the U.S. Court of Appeals for the Third Circuit that the biopharma industry has said will make it more difficult for drug companies to pursue patent infringement cases in keeping with Hatch-Waxman.
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Merck, Orphazyme, Sanofi.
A new FDA discussion paper addresses cybersecurity issues specific to the servicing of medical devices, with the goal of guiding the conversation about potential challenges and opportunities. It coincides with a larger agency initiative to provide more clarity on servicing.
It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Hecin, Holista Colltech.
Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints.
Shares in Orphazyme A/S cratered after the FDA rejected its arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition where fat builds in tissues and organs.
RSS
