Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
HONG KONG – South Korean biopharmaceutical company Kolon Tissuegene Inc. got a new lease on life as the U.S. FDA lifted the hold on the phase III trial for its lead candidate, Invossa-K (Invossa), for the treatment of osteoarthritis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Ascendis, Autolus, Eagle, Emmaus, Index, Mayne, Mithra, Provention, Regeneron, Tetra, Tissuetech, Zai.
The FDA approved Urogen Pharma Ltd.’s mitomycin gel, an orphan drug branded Jelmyto, on April 15, offering patients the first non-surgical option for low-grade upper tract urothelial cancer (LG-UTUC) and granting the Princeton, N.J.-based company with its first marketed product.
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athersys, Forma, Gensight, Harbour, Humanigen, Pfenex, Remegen, Sinovac, Tetra, Urogen.
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
When it comes to guidance on interchangeables, the Pharmaceutical Research and Manufacturers of America (PhRMA) has some guidance for the FDA: Be more definite.
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