Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Cansino, Incyte, Insmed, JCR, Merck, Protagonist, RDIF, Zealand.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Augustine, Celonic, Cipla, Cure, Curevac, Devpro, Evelo, Eyenovia, Eversana, Fairjourney, Hepion, Hoth, Immunome, Intervivo, Iontas, JSR, Lead Discovery, Life Edit, Lyell, Maze, Mindset, Novo Nordisk, Organicell, Plus, Point, Sangamo, Scholar Rock, Siga, Tallac, Viracta, Xoma, Zenas.
The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.
LONDON – Positive interim data from the U.S. trial of Astrazeneca plc’s COVID-19 vaccine have added yet more evidence it is effective in older adults and quelled concerns about serious thrombotic events that led countries in Europe to pause use of the vaccine earlier this month. Overall, the vaccine showed 79% efficacy in preventing symptomatic COVID-19, and was 100% effective in preventing serious disease and hospitalization. The effect was comparable across different ethnicities and age groups, with 80% efficacy in participants over 65 years of age. The analysis is based on 141 cases of COVID-19 infection.
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.
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