It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy. While it’s not exhaustive, the annual list is composed of online and physical markets around the world that deal in commercial-scale counterfeiting and piracy across all sectors, including biopharma and med tech.
U.S. FDA approvals in 2022 are down by more than 30%, while new molecular entity approvals have been cut in half. So far this year, the U.S. FDA has approved 93 drugs and biologics, including expansions into new indications. In comparison with each of the last three years, it is a significant drop. There were 136 approvals in 2021, 143 in 2020 and 134 in 2019 announced by the end of August.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ultrasight.
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ainos, Can-Fite, Enlivex, Innocare, Janssen, Keymed, Moderna, Pfizer, Tachyon, Valneva.
The U.S. FDA granted breakthrough device designation to startup Brainspec Inc. for its non-invasive virtual brain biopsy system. The company uses standard magnetic resonance imaging equipment to measure brain chemistry rather than to create images, providing a more detailed view of pathophysiology involved in a range of neurological disorders.
Moderna Inc.’s and Pfizer Inc.-Biontech SE’s COVID-19 bivalent boosters could be coming to the U.S. in the first week or so of September – even though the U.S. FDA just received the completed emergency use authorization (EUA) requests for the vaccines this week. The CDC is already taking pre-orders from providers, states and other jurisdictions for the yet-to-be authorized booster doses as part of its fall-winter booster campaign strategy. It also scheduled a Sept. 1-2 meeting of its Advisory Committee for Immunization Practices, signaling that it expects the FDA to grant the EUAs by the end of August.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brain Scientific, Brainspec, Cordx.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asklepios, Beigene, Bristol Myers Squibb, Foghorn, Iecure, Jaguar, K36, Merck, Northwest, Synlogic.
The recall of CPAP, BiPAP and ventilator devices made by Philips Respironics Inc., of Murrysville, Pa., is now in its second year, but the rate of reported adverse events was exceedingly low prior to the onset of the June 2021 recall. Those numbers continued to climb in May, June and July of 2022, however, reaching 48,000 medical device reports and 44 deaths said to be associated with the recalled devices, a pace that would easily overwhelm the volume of reports seen in the 12 months ending April 30, 2022.
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