EMA
The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.
Business & Industry
- Amgen successfully completes acquisition of Five Prime Therapeutics
- GSK and Vir Biotechnology announce EMA review of dual-action monoclonal antibody VIR-7831 for the early treatment of COVID-19
- Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%
- Pfizer and BioNTech request regulatory agencies expand emergency use of their COVID-19 vaccine to adolescents
- Valneva reports positive Phase 1/2 data for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001
Research & Development
- SARS-CoV-2: New findings on the persistence of neutralizing antibodies
- Massive fragment screen points way to new SARS-CoV-2 inhibitors
- B.1.1.7. variant more transmissible, does not increase severity, Lancet studies suggest
- COVID-19 causes 'unexpected' cellular response in the lungs
- Clinical trial completion rates decline during COVID-19 pandemic
- Study identifies possible COVID-19 drugs - including several that are FDA-approved
- COVID-19 convalescent plasma with greater antibody levels is safe and shows promise
Conferences & Events
- Scientists urge for investment now in highly potent vaccines to prevent the next pandemic
- CPhI Worldwide to return in 2021
- Reuters Events' Cell & Gene Therapy USA
- Total health: Build a better healthcare system
- Don't fall for the 'next best action' trap
- Locking down shape-shifting spike protein aids development of COVID-19 vaccine
- COVID-19 vaccine innovation could dramatically speed up worldwide production
Regulatory Affairs
- FDA revokes emergency use authorization for monoclonal antibody Bamlanivimab
- Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
- AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
- Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
- EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events