U.S. lawmakers, advocacy groups and state officials who urged the Department of Health and Human Services (HHS) to march in on patents covering Gilead Sciences Inc.’s COVID-19 drug, Veklury (remdesivir), likely were disappointed, and perhaps surprised, by the Government Accountability Office’s (GAO) conclusion this week that, despite a $161.5 million taxpayer investment in the antiviral’s development, there are no government patents to march in on.
As COVID-19 vaccinations continue to roll out, momentum builds with strong phase III data for what could become the fourth and fifth walls of defense in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Autolus, Beyondspring, Lannett, Moderna, Neurophth, Respirent, Sanofi, Secura, Taiho, United.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief:, Agilent Technologies, Alydia, B. Braun, Delfi Diagnostics, Infraredx, Janssen, Komodo Health, Merck, Natera, Nipro, Organon, Oscar A-Co, Premier, Takeda, Tempus, Tesis Labs.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Aptorum, Athersys, Biontech, Equillium, Flexion, Istari, Kamada, Nascent, Outlook, Pfizer, Pharnext, Regeneron.
If these top-line phase III results were a grade card for 12- to 15-year-olds, they would be on the honor roll: The Pfizer Inc.-Biontech SE COVID-19 vaccine is 100% effective for the age group and produced robust antibody responses.
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