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Home » Topics » Regulatory

Regulatory
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U.S. health compass

Azar: Grassley-Wyden bill leaves ‘plenty of room’ for profits, innovation

Feb. 13, 2020
By Mark McCarty
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.
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Regulatory front for Feb. 13, 2020

Feb. 13, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Feb. 12, 2020

Feb. 12, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cook, Medtronic, Tenet Healthcare.
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2-12-hyperfine-MRI.png

Bedside MRI system receives green light from the FDA

Feb. 12, 2020
By Liz Hollis
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.
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Earth threatened by virus

COVID-19 could prove an expensive distraction for life sciences

Feb. 12, 2020
By Mark McCarty
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.
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Colombia expands price caps: 2,487 drugs now have price regulation

Feb. 12, 2020
By Sergio Held
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.
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Regulatory front for Feb. 12, 2020

Feb. 12, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Reactants ignite, China syndrome melts down FDA drug-quality meeting

Feb. 11, 2020
By Randy Osborne
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.”
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Architectural pillars

Regulatory front for Feb. 11, 2020

Feb. 11, 2020
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.
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Regulatory front for Feb. 11, 2020

Feb. 11, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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