Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Blueprint, Dialectic, Exicure, Exithera, Idorsia, Junshi, Kempharm, Oblato, On Target, RDIF, Saniona, Sorrento, Wellmarker, Xentria.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Applied Biomath, Astrazeneca, Betterlife, Black Diamond, Cipla, DNA Script, Emmaus, ERS, Eurofins, Exmceuticals, F4, Global Cannabinoids, GSK, Halberd, Hoth, Immunitas, Isa, Kainos, Kamada, Kindeva, Medicinova, Morphosys, Mylan, Nanobiotix, Oasmia, Otsuka, Partner, Repertoire Immune, Resverlogix, Sirs, United, Vaxalto.
NEW DELHI – Significant disruptions to supplies of active pharmaceutical ingredients (APIs) from China caused by the COVID-19 pandemic have led India to fundamentally rethink its supply chains and the structure of its pharmaceutical industry, according to industry executives and consultants.
Months of talks between Johnson & Johnson (J&J) and Merck & Co. Inc. about a COVID-19 vaccine manufacturing partnership came to fruition March 2 with the Biden administration hailing the deal as an “unprecedented historic” agreement between two long-time rivals.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA updates recognized standards list; Advisory hearing scheduled for Transmedics’ OCS; GAO said ‘no’ to Spartan Medical appeal; CDC posts updates on SARS sequencing.
LONDON – The SARS-CoV-2 variant of concern that caused a wave of infection in Manaus, Brazil, in December and January has been found to be both more transmissible and to evade immunity conferred by prior natural infection with the virus.
With several more emergency use authorizations (EUAs) across the globe, COVID-19 efforts to flatten the emerging variants with cocktail therapies and tweaked vaccines are frantically underway. BioWorld has tracked 884 therapeutics and vaccines that have entered development for the deadly SARS-CoV-2 virus since it first emerged more than a year ago, and the U.S. government has now provided EUAs to three vaccines and six therapies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Argenx, Astrazeneca, Beigene, Biocryst, Biogen, Eisai, Eyenovia, Fibrogen, Merck, Molecular Targeting Technologies, Oyster Point, RDIF, Sorrento, Strongbridge.
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