Safety likely will be top of mind when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee meets Feb. 28 and March 1 to advise the agency on two respiratory syncytial virus (RSV) vaccines proposed for use in adults who are at least 60 years old.
While the FDA has yet to take a stance on whether risk evaluation and mitigation strategy (REMS) patents can be listed in its Orange Book, the U.S. Court of Appeals for the Federal Circuit weighed in Feb. 24 with a decisive “no” when those patents only claim a system.
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s.
Looking to turn around the decline of clinical trials within its borders, the U.K. government appointed James O’Shaughnessy, a former health minister, board member of Health Data Research UK and a senior partner at Newmarket Strategy, to conduct an independent review of the country’s commercial clinical trial landscape.
Now that the U.S. FDA has granted accelerated approval for Biogen Inc./Eisai Co. Ltd.’s early Alzheimer’s drug, Leqembi (lecanemab), the Centers for Medicare & Medicaid Services (CMS) is being pressured to rethink its coverage of amyloid-targeting monoclonal antibodies.
If the Feb. 16 hearing before the U.S. Senate Commerce Committee is anything to go by, it’s almost a given that the bipartisan Pharmacy Benefit Manager (PBM) Transparency Act will eventually be passed by the Senate. But its journey through the Republican-controlled House could be more uncertain in light of growing concerns about an “activist agenda” at the FTC.
In decrying high U.S. drug prices, lawmakers often cite statistics about the number of patients who forgo or ration their prescriptions because of the out-of-pocket cost. Those discussions overlook the role payer utilization management tactics, including prior authorization, may play in patients abandoning their treatment, be it a specific drug or an imaging service.
A trio of proposed Medicare drug payment models that made a Feb. 14 debut in the U.S. is playing to mixed reviews. Two of the models to be tested by the U.S. Centers for Medicare & Medicaid Services (CMS) Innovation Center seem to “address the real problems underlying prescription drug pricing – patient out-of-pocket expenses and better payment systems that reward the value a medicine brings to the patient and the overall health care system,” said John Murphy, chief policy officer for the Biotechnology Innovation Organization. But he called the third model, which is expected to restrict Medicare payment for some Part B drugs that have indications with accelerated approval, “an attack on the accelerated approval pathway,” which Congress mandated to spur investment and innovation in areas of unmet medical need.
In decrying high U.S. drug prices, lawmakers often cite statistics about the number of patients who forgo or ration their prescriptions because of the out-of-pocket cost. Those discussions overlook the role payer utilization management tactics, including prior authorization, may play in patients abandoning their treatment, be it a specific drug or an imaging service.
With an eye toward the future, the U.S. Patent and Trademark Office (USPTO) is seeking comment on artificial intelligence (AI) technologies and inventorship issues that may arise as AI takes on a bigger role in innovation.
