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
- Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies
- Regeneron's REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients
- COVID-19 Long-Acting AntiBody (LAAB) combination AZD7442 rapidly advances into Phase III clinical trials
- Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19
- BioNTech and Pfizer initiate rolling submission to European Medicines Agency for SARS-CoV-2 vaccine candidate BNT162b2
Research & Development
- A vaccine project funded by the Federal Ministry for Economic Affairs and Energy develops a second generation COVID-19 vaccine
- NIH begins large clinical trial to test immune modulators for treatment of COVID-19
- Scientists identify common vulnerabilities across SARS-CoV-2, SARS-CoV-1 and MERS coronaviruses
- Popular COVID-19 conspiracies linked to vaccine 'hesitancy'
- World Bank approves $12 billion for COVID-19 vaccines
- Can an antibody 'cocktail' prevent COVID-19 infection?
- Total deaths recorded during the pandemic far exceed those attributed to COVID-19
Conferences & Events
- 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
- Wearable Injectors and Connected Devices Conference 2020
Regulatory Affairs
- Investigational COVID-19 vaccine well-tolerated, generates immune response in older adults
- EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
- FDA issues emergency use authorization for convalescent plasma as potential promising COVID-19 treatment
- FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
- FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials