Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.
The executive orders (EOs) pouring out of the Trump White House, and the resulting court challenges, continue to pile up, deepening the uncertainty hanging over the life sciences sector and the U.S. economy in general.
On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”
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.
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