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
- Roche opens access to pathology imaging tools to improve patient care
- Pfizer and BioNTech submit a variation to EMA with the data in support of a booster dose of COMIRNATY®
- Sandoz strengthens pipeline by entering into agreement for biosimilar bevacizumab, a key oncology medicine
- SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate
- Lilly and Lycia Therapeutics enter into strategic collaboration to discover and develop novel lysosomal targeting chimera (LYTAC) degraders
Research & Development
- COVID-19 nasal vaccine candidate effective at preventing disease transmission
- How a plant virus could protect and save your lungs from metastatic cancer
- Scientific evidence to date on COVID-19 vaccine efficacy does not support boosters for general population
- NIH scientists build a cellular blueprint of multiple sclerosis lesions
- First-in-human clinical trial for a vaccine to treat opioid use disorders enrolls first patients
- No serious health effects linked to mRNA COVID-19 vaccines
- Blood vessels produce growth factor that promotes metastases
Conferences & Events
- Novartis, Bayer and Boehringer Ingelheim to showcase their commitment to a reimagined pharma industry
- 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
Regulatory Affairs
- FDA advances data, IT modernization efforts with new office of digital transformation
- ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
- FDA approves first COVID-19 vaccine
- FDA approves new treatment for Pompe disease
- FDA approves first interchangeable biosimilar insulin product for treatment of diabetes