HONG KONG – Cadila Healthcare Ltd. (Zydus Cadila) has won approval for its saroglitazar to be used as the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH) in India. The green light from the Drug Controller General of India (DCGI) makes saroglitazar the first drug in the world approved for this indication.
PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends.
HONG KONG – Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy designation by the U.S. FDA based on data from two independent phase I/II trials.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, COVID-19, Eastgate, India’s Central Drug Standard Control Organization, India’s Directorate of Revenue Intelligence, SEC.
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.
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.
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.
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