Shares of Reata Pharmaceuticals Inc. tanked unexpectedly Feb. 27, a day before the U.S. FDA is set to make a decision on the NDA seeking approval of once-daily Nrf2 activator omaveloxolone for Friedreich’s ataxia, on reports that Billy Dunn, the director of the FDA’s Office of Neuroscience, was stepping down from his position.
Safety likely will be top of mind when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee meets Feb. 28 and March 1 to advise the agency on two respiratory syncytial virus (RSV) vaccines proposed for use in adults who are at least 60 years old.
The U.S. FDA marked the 40th anniversary of the Orphan Drug Act with Rare Disease Day 2023 as Robert Califf, the agency’s commissioner of food and drugs, opened the day by expressing his wonder and accompanying concern regarding gene editing and gene therapy.
While the FDA has yet to take a stance on whether risk evaluation and mitigation strategy (REMS) patents can be listed in its Orange Book, the U.S. Court of Appeals for the Federal Circuit weighed in Feb. 24 with a decisive “no” when those patents only claim a system.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Lucira Health, Milestone Scientific.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Astrazeneca, Beigene, Chiesi, Daiichi Sankyo, Incyte, Janssen, Merck, Protalix, Regeneron, Ridgeback, Servier, Sobi, Timber.
Medtronic plc recently received the CE mark for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) strengthening its cardiovascular portfolio which saw a 7% year-on-year growth in the third quarter of its fiscal year 2023.
Plans by the U.K. government to claw back from pharma companies another 3.1% of the proportion of the drugs they sell to the National Health Service have been heavily criticized by the pharmaceutical industry as sending the “worst possible signal” to global investors. The Department of Health and Social Care announced in a consultation in December that it planned to increase the statutory scheme payment percentage from 24.4% to 27.5% starting April 1, 2023.
The SEC and the U.S. Attorney’s Office for the Southern District of New York charged a former pharmaceutical executive and his cousin Feb. 23 with the insider trading of Eastman Kodak Co. stock prior to a COVID-19 partnership with the U.S. government to support the launch of Kodak Pharmaceuticals.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Areteia, Bioatla, Enlivex, Ips Heart, Merck, Moderna, Octapharma, Regeneron.
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