To accelerate drug development targeting the pandemic, the FDA issued final guidance May 17 on master protocols for drugs intended to prevent or treat COVID-19 infections. Although the guidance is geared toward developing COVID-19 drugs, the FDA said it expects master protocols to continue to play an important role in addressing the public health needs in future pandemics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Adamis, Algernon, Apellis, Diamedica, Everest, Icanomab, Immunitybio, Ix, Kiromic, Mindmed, Pharmather, RDIF.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Amo, Antengene, Appili, Athenex, Baudax, Foghorn, Galera, GSK, Incyte, Knopp, Regeneron, Sanofi, Seelos.
LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium.
Digital health and diagnostic efforts continue to dominate med-tech deal-making so far in 2021, while activity focused on medical devices has dropped over the last few years. COVID-19 partnerships also have fallen since last year. Digital health accounts for 43%, the largest portion, of deals this year. About 239 deals are targeting this space, including pandemic efforts. Diagnostic efforts represent about 19%, or 103, of the total deals.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Becton Dickinson, Crannmed, Labcorp, Zoll Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biotheranostics, Caregility, Diaceutics, Genetron, Halberd, Health Recovery Solutions, Hologic, Identifysensors Biologics, Osi Systems, Second Sight Medical Products, Seracare Life Sciences, Spacelabs Healthcare.
Roughly a year and a half after the start of the COVID-19 pandemic, many unknowns remain about the future of the virus. How it will mutate, how long protection from either illness or vaccination will last, when it will cease to be a pandemic and instead be endemic, even whether the worst is still ahead. And there is also an increasing acknowledgment that there remain unknowns about SARS-CoV-2’s past.
More than 150 U.S. patents could be at stake if the World Trade Organization (WTO) were to adopt an intellectual property waiver as originally proposed by India and South Africa.
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