Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Braeburn, Cellenkos, Citius, Helsinn, Nkmax, Renovorx, Rigenerand, Sapience, Tetra Bio-Pharma, Y-mabs.
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Accord, Altimmune, ANI, Astrazeneca, Aveo, Compugen, Cytodyn, Eli Lilly, Genentech, Henlius, Hutchison China (Chi-Med), J&J, Longeveron, Merck, Mundipharma, Myovant, Myr, Opko.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of a historic first vaccine approval, having secured a positive vote May 29 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Boehringer, Chi-Med, Immune-Onc, J&J, Lilly, Menlo, Nabriva, Novartis, Onxeo, Orphazyme, Roche, Santhera, Takeda.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ashvattha, Basilea, Bird Rock, Cardiff, Cerecor, Chiesi, Immodulon, Macrogenics, Moleculin, Orpheris, Phasebio, Protalix, Roche, Theraly.
Intravenous artesunate, the international standard of care to treat severe malaria, has finally won full FDA approval for the condition, which affects about 300 of the approximately 2,000 people diagnosed with malaria in the U.S. each year.
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