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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Brainsway, National Government Services, Wisconsin Physician Services.
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.
Guilford, Conn.-based Hyperfine Research Inc. has received the U.S. FDA’s nod for a bedside magnetic resonance imaging (MRI) system and is eyeing this summer for shipments. The portable system can be wheeled directly to the patient’s bedside and plugs into a standard electrical wall outlet.
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.
BEIJING – China will kickstart a phase III trial Feb. 3 to determine whether patients with 2019-nCoV can be treated with Gilead Sciences Inc.’s NUC inhibitor,...
HONG KONG – In another example that communication is proving as difficult as containment in the current coronavirus outbreak, China’s state media reported, to...
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV...
SEATTLE – Tracing the family tree of COVID-19 through its evolving DNA sequence makes it possible to disprove many false claims circulating on social media about...
BEIJING – Chinese regulators are speeding up to approve more test kits for the deadly coronavirus that already has killed 170 people and infected more than 7,700...
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