Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Algernon, Anavex, Can-Fite, Elixirgen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Clarity, FSD, Genmab, Novartis, Pierre Fabre, Revive, Specialised Therapeutics, Treadwell, Trevena.
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.
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