The latest global regulatory news, changes and updates affecting biopharma, including: MHRA resumes some onsite inspections; Kyprolis discount opens door to U.K. coverage; HHS delays Trump ‘Sunset’ rule.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chiasma, Clarus, Crinetics, Lumos, Neurocrine, Strongbridge, Rezolute, Rhythm, Theratechnologies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: SUNSET rule suspended; Alliance calls for speedy nomination of FDA commissioner; Pandemic costly to TB effort; FDA announces May 4 patient data meeting.
CAJICA, Colombia – Countries in Latin America have joined those in Europe expressing mixed reactions about continuing their vaccination plans with the AZD-1222 SARS-CoV-2 vaccine developed by Astrazeneca plc and the University of Oxford, following reports of alleged adverse events.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Idorsia, J&J, Kiniksa, RDIF.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Hua, Oramed, Premas, RDIF, Revive, Strides, Vtv.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amyndas, Bluesky, Clovis, Eisai, Idera, Incyte, Merck & Co., Sarepta.
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