“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition.
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.
HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs. In a note dated March 3, India’s Directorate General of Foreign Trade compiled a list of now restricted APIs and formulations that were previously free to export. It ranged from paracetamol and erythromycin salts to progesterone and vitamin B1, 6 and 12.
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.
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
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