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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.”
Aimmune Therapeutics Inc. wasted no time moving ahead after last week’s FDA approval of Palforzia for peanut allergy as the Brisbane, Calif.-based company obtained an exclusive worldwide license to develop and commercialize Xencor Inc.’s humanized monoclonal antibody, XmAb-7195, for treating allergic asthma.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advantage Choice Care, Cardinal Health, Ethicon, Tele Medcare.
Now that U.S. Health and Human Services (HHS) Secretary Alex Azar has declared a nationwide public health emergency due to the 2019 novel coronavirus (2019-nCoV), HHS is saying it may need more money to help it be as proactive and aggressive as possible in detecting the virus and containing an outbreak.
PERTH, Australia – Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).
BEIJING – The current speed of new developments in the 2019-nCov outbreak is illustrated by a Jan. 28, 2020, press conference in Munich, where Andreas Zapf, head of the infection task force in the Bavarian ministry for health and food safety, briefed reporters on the first confirmed German case.
HONG KONG – Aiming to increase the financial stability of the national health care insurance system, Japan has announced a list of 17 drugs for which prices will be reduced. The country’s Central Social Insurance Medical Council, an advisory group from the Ministry of Health, Labour and Welfare (MHLW), approved the drug repricing system on Jan. 22.
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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