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.
“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.
LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts.
The first wave of biosimilars began lapping at U.S. shores five years ago when the FDA approved Sandoz Inc.’s Zarxio on March 6, 2015, giving it a label identical to that of its reference biologic, Amgen Inc.’s Neupogen (filgrastim). But the tsunami of biosimilars, and the multibillion dollars of savings they were expected to bring, has yet to wash ashore.
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.
In a flurry of catch-up following the coronavirus outbreak in China, a number of biopharma companies have announced development within the last few weeks to address the ever-spreading infection known as COVID-19.
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 – Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab).
DUBLIN – Could a recombinant human protein drug rejected by Glaxosmithkline plc in 2019 benefit patients with COVID-19 infection? Apeiron Biologics AG disclosed Wednesday Feb. 26 that an investigator-initiated pilot study of APN-01 is getting underway in Guangzhou, China.
BEIJING – While repurposing drugs may be a quick solution to an epidemic like COVID-19 that has a limited research window, it’s just luck as to whether an already available drug candidate exists for newly emergent diseases. Experts say it’s more realistic to develop better drugs instead of attempting to repurpose old ones.
RSS
