Having already notched approvals in the EU and U.K., Astrazeneca plc hopes to prime the pump for a U.S. approval of nirsevimab as a respiratory syncytial virus (RSV) prophylactic for infants when it makes its case June 8 before the FDA’s Antimicrobial Drugs Advisory Committee.
As Monica Bertagnolli, U.S. President Joe Biden’s choice to be the next NIH director, meets with senators to gather support for her confirmation, she’s sure to be grilled by some of them about her stance on whether the agency can march in on drug patents based on a drug’s list price. Up until now, NIH directors have said no. A change in that policy, along with nearly flatline NIH spending and other new government initiatives, could impact private investment in drug R&D by increasing the cost of research and lowering the return on investment.
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Regent, Avadel, Bioinvent, Canbridge, Daiichi Sankyo, Foghorn, Hemogenyx, Innovent, Kyverna, Springworks, Theratechnologies.
U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing.
China continues to ramp up efforts to digitize its health care system, as it moves closer toward a 2025 deadline that is part of a nationwide plan. Several of the country’s largest tech conglomerates now have digital health operations that are beginning to show profits and are expected to grow significantly over the next decade.