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.
After nearly three months of the U.S. federal government operating on stopgap spending measures, Congress has agreed to a $1.4 trillion spending bill for fiscal 2021. The omnibus package, which includes $97 billion for the Department of Health and Human Services, gives both the FDA and NIH small increases in funding.
The latest global regulatory news, changes and updates affecting biopharma, including: USPTO to expand diversity in innovation; Opioid prescriptions could cost Walmart billions.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Appili, Biogen, Cytodyn, Dr. Reddy’s, Innovation, Kempharm, Nicox, Ocular, Onconova, Orchard, Polyphor, Takeda, Uniqure, Vertex, Ziopharm.
LONDON – The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use. The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27.
A day after the FDA’s Vaccines and Related Biological Products Advisory Committee lent its support to Moderna Inc.’s COVID-19 vaccine, the agency granted it emergency use authorization (EUA). About 20 million doses will be delivered by the end of December and the rest in the first quarter of 2021, according to Moderna.
The latest global regulatory news, changes and updates affecting biopharma, including: EMA updates on cyberattack; CDSCO extends import leniency; FDA’s obsolete human tissue rule on scrapheap.
Following a priority review of Orgovyx (relugolix), an oral hormone therapy developed by Myovant Sciences GmbH, the FDA has approved the medicine for the treatment of adults with advanced prostate cancer. The first success among three indications for which Myovant has developed the gonadotropin-releasing hormone (GnRH) receptor agonist, the green light marks Myovant’s transformation into a commercial-stage company, SVB Leerink analyst Ami Fadia noted. Company shares (NYSE:MYOV) fell 4.5% to $23.61 following the Dec. 18 approval.
Although FDA approvals in 2020 are falling just shy of records, the amount of regulatory news this year is more than twice the amount seen only four years ago and a 41% increase over that reported in 2019. The COVID-19 pandemic accounts for roughly 14% of the total, but regardless, by all accounts, 2020 has been an excessively busy year for both the biopharma industry and regulatory agencies.
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