Hemosonics LLC said it was recently awarded U.S. FDA clearance for a new hemostasis test cartridge assay it said significantly expands the indications for clinical use of its existing Quantra system to now also include trauma and liver transplantation procedures. The expanded Quantra hemostasis system with its QStat cartridge will add to capabilities of the system’s QPlus cartridge assay already established in the point-of-care and lab-based, whole blood hemostasis testing market.
The CMS had floated a coverage concept for devices routed through the U.S. FDA breakthrough devices program shortly before the Biden administration took office, but the change in administration proved lethal to the program in terms of its initial contours. The latest development in this saga would have the program revert to an expanded use of the existing Medicare coverage with evidence development (CED) program, a far cry from the original concept of same-day coverage upon FDA approval or clearance of the device.
The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abm Respiratory Care, Mediwound, Vericel.
Citing an "atypical FDA review process and corporate greed" ahead of the controversial approval of Biogen Inc.'s Aduhelm (aducanumab), Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) called for "corrective actions" at the agency to "re-earn the trust of the American people." Pallone's comments prefaced a report drawn from 18 months of investigation around the regulatory review and approval process for the Alzheimer's disease drug, as well as Biogen’s pricing strategy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Beigene, Calliditas, Everest, Mediwound, Merck & Co.
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
The U.S. FDA managed to wrap up a guidance for clinical decision support (CDS) products after several years, one of several projects the agency was liable for in the area of digital health. While a much-needed draft guidance for change control for artificial intelligence algorithms made the guidance agenda for the FDA’s new fiscal year, that draft is only a B draft guidance priority, suggesting that a final guidance might not emerge until calendar year 2024, possibly later.
U.S. FDA approvals in 2022 are down by 31.3% compared with last year and clearances for new molecular entities are at the bottom of all recent years. As of Dec. 20, the agency had approved 143 drugs and biologics in 2022, including supplemental filings, just slightly higher than the 138 approvals in 2016, but far behind the 208 approvals recorded in both 2021 and 2017.
Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
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