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.
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
The latest global regulatory news, changes and updates affecting biopharma, including: Aurolife, CDC, Central Drugs Standard Control Organisation, FDA, Glaxosmithkline, National Institute of Allergy and Infectious Diseases, Sanofi, U.S. Court of Appeals, World Health Organization.
The Dec. 9, 2019, FDA draft guidance spelling out performance criteria for magnetic resonance coils seemed to take up a relatively simple matter, but industry’s response suggested otherwise. The Medical Imaging & Technology Alliance (MITA) recommended that the agency undertake nearly two dozen changes to the draft, including a change to the title to indicate that the scope of the guidance is limited to receive-only MRI coils.
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).
Palo Alto, Calif.-based Varian Medical Systems Inc. has won the U.S. FDA’s nod for its Ethos therapy, an artificial intelligence (AI)-driven holistic solution that is aiming to transform cancer care. This solution is designed to deliver an entire adaptive treatment in a typical 15-minute slot and is intended to put the patient at the center of care, noted Chris Toth, president of Varian Oncology Systems.
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