HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19. China now has six clinical trials investigating the drug, originally developed for influenza and also tested against Ebola virus disease.
PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.
A list of biopharma companies and nonprofit entities, including academia, working feverishly to find a vaccine or antiviral treatment to address the rapidly spreading coronavirus, now known as COVID-19, has more than doubled, increasing from about 30 a few weeks ago to 71 as of March 6.
HONG KONG – U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. has teamed up with Mount Sinai Health System, New York City's largest academic medical system, to develop novel biotherapies in oncology and immunology. The two parties will also be using Harbour’s H2L2 Harbour Mice platform to develop a monoclonal antibody (MAb) against the coronavirus that has turned into a global epidemic.
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.
LONDON – The Gates Foundation and Wellcome Trust have joined forces with financial services specialist Mastercard in establishing a $125 million seed fund to accelerate development of drugs to treat COVID -19.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Kyowa Kirin, Noxopharm, Shionogi, Takeda, Tessa, Ultragenyx.
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