Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
Health and Human Services (HHS) Secretary Alex Azar was peppered with questions about the Trump administration’s budget proposal for fiscal 2021 during a Feb. 13 Senate hearing. However, another theme that resonated during the hearing was Senate legislation addressing drug prices. Azar addressed the issue of price caps, while noting that the bill “leaves plenty of room” for both ample profit margins and innovation in drug development.
The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable. Ron Klain, who served as the Obama administration’s coordinator for the response to the Ebola virus, said during an Aspen Institute seminar that drug makers took a hit in their efforts to develop a vaccine for the Ebola virus, and thus there is a need to de-risk these and other development efforts in the private sector.
BOGOTA, Colombia – As part of an effort to further control drug costs, Colombia set price caps on 770 drugs in late January. The move takes the total of price-regulated drugs in the Latin American country to 2,487. The new caps on drug prices apply to a broad range of products from generics to biosimilars and to biologics such as ranibizumab, trastuzumab, vedolizumab, secukinumab and pembrolizumab, among dozens of others.
Pediatric gene editing specialist Logicbio Therapeutics Inc. has revealed an FDA clinical hold on a planned phase I/II trial of its lead candidate, LB-001, an investigational therapy for rare inherited metabolic disorder methylmalonic acidemia (MMA).
The Association for Accessible Medicines (AAM) is garnering support in its Ninth Circuit challenge to a new California law that seemingly thumbs its nose at a 2013 U.S. Supreme Court ruling on so-called pay-for-delay patent settlements.