In a rare move, the FDA disclosed summary trial information May 17 about Cytodyn Inc.’s Vyrologix (leronlimab), noting that currently available data don’t support the clinical benefit of the drug as a COVID-19 treatment.
DUBLIN – Bergenbio ASA joins an expanding list of companies whose candidate drug has failed to attain the primary endpoint of a clinical trial in COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Advicenne, Affyimmune, Biontech, Brii, Cytodyn, Eli Lilly, Innocare, Innovent, Kinnate, Merck, Pfizer, Qpex, Relief.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amarin, Apnimed, Bergenbio, Catalyst, Cybin, GSK, I-Mab, Leo, Medicago, Metacrine, Mustang, Novo Nordisk, Realta, Roche, Sarepta, Seven and Eight, Shield.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amazon, Amwell, Cerus, Ellerca, Outset Medical, Quidel, Roche, Signify Health.
Seychelles has seen rising numbers of COVID-19 cases despite 61% of its population being fully vaccinated as of May 8, calling into question the effectiveness of the COVID-19 vaccines used by the island nation.
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.
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