The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
The U.S. Congress is turning its attention, once again, to bipartisan pharmacy benefit manager (PBM) reforms, after efforts to rein in PBM practices died with the 118th Congress. With an eye on finally getting them passed, the House Energy and Commerce Committee kicked off the process with a Feb. 26 hearing that was supposed to be focused on the reform legislation the committee approved last year and follow-on legislation to rein in harmful PBM practices.
The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
Citing recent executive orders that suggest additional cuts to the federal workforce may be in the offing, U.S. Sens. Patty Murray, D-Wash., and Jeanne Shaheen, D-N.H., wrote to Health and Human Services Secretary Robert Kennedy urging him to end “indiscriminate cuts that will cause lasting harm to FDA’s public health mission” and to protect the agency’s statutory obligations.
Though it’s been used off-label for more than three decades to treat cerebrotendinous xanthomatosis, Mirum Pharmaceuticals Inc.’s chenodiol gained an official U.S. FDA nod Feb. 21 as the first drug approved specifically for treating the rare autosomal recessive lipid storage disease.
The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
With massive terminations, data removals, holds on U.S. government funding, cancellation of various programs and meetings, the potential for 25% tariffs on medical products and a multitude of court challenges and appeals, the dust is flying thick at the FDA, NIH and throughout the Department of Health and Human Services (HHS).
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