Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
With the FDA approval of Novartis AG’s Isturisa (osilodrostat), an oral treatment for adults with Cushing’s disease, Recordati SpA, of Milan, is planning its U.S. market launch for the second or third quarter of this year. Recordati, which acquired Isturisa’s worldwide rights from Novartis in October for $390 million, expects sales to peak at $100 million annually.
“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.