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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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airos Medical, GE Healthcare, Gynesonics, Quest Diagnostics.
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.
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nantong Egens Biotechnology, Ntbio Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Zionexa.
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