Although it held off on a proposed rule change addressing yet another gaming opportunity for drug manufacturers in the U.S., the Centers for Medicare & Medicaid Services (CMS) still is pressing its policy for including more 505(b)(2) drugs in multiple source reimbursement codes, which could force them to compete with generics on price.
HONG KONG and BEIJING – China’s Sinovac Biotech Ltd. delayed releasing trial data from its Coronavac COVID-19 vaccine while the National Medical Products Administration (NMPA) accepted an NDA from China National Biotec Group (CNBG) for its own vaccine, BBIBP-CorV.
As expected, the Centers for Medicare & Medicaid Services’ (CMS) interim final rule to implement a seven-year most favored nation (MFN) Medicare payment model for 50 drugs crashed into the brick wall of a U.S. court.
Following a better-than-expected commercial liftoff for the overactive bladder medicine Gemtesa (vibegron) in its first market, Japan, the Dec. 23 FDA approval for the medicine opens a new commercial chapter for Urovant Sciences, a company that’s on its way to being a wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd.'s Sumitovant Biopharma Ltd.
Shares of Voyager Therapeutics Inc. and its partner, Neurocrine Biosciences Inc., fell in early trading Dec. 23 after Voyager announced an FDA clinical hold on the phase II Restore-1 trial of VY-AADC, an adeno-associated virus-based gene therapy Neurocrine is developing as NBIb-1817 for the treatment of Parkinson's disease. The trial had been paused since at least November as its data safety monitoring board reviewed MRI abnormalities in some study participants.
In an exclusive interview with BioWorld on the challenges facing a deeply divided Congress and some of the highlights of his years in the U.S. House, retiring Congressman Greg Walden (R-Ore.) said that once the COVID- 19 pandemic is over, federal policymakers should hold a summit with officials from states and major cities to look at a new preparedness partnership that would ensure the availability of strategic medical supplies.
The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.
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