Jan 29, 2021 | EMA, News, Regulatory
The European Medicine’s Agency (EMA) announced today (1/29) it’s approval of the AstraZeneca and University of Oxford’s COVID-19 vaccine. The approval marks the third vaccine passed by the EMA. The vaccine is administered as two doses, with the second coming between 4... 
Jan 15, 2021 | News, Regulatory
The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use... 
Jan 12, 2021 | News, Regulatory
The European Medical Association (EMA) granted NeuroSense Therapeutics, a clinical stage drug development company, orphan drug designation today (1/12) for PrimeC, a unique combination drug for treatment of Amyotrophic Lateral Sclerosis (ALS). The U.S. Food and Drug... 
Dec 10, 2020 | News, Regulatory
BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency’s (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that... 
Dec 1, 2020 | News, Regulatory
After finding that the Johnson & Johnson vaccines triggered antibody cell formation to fight COVID-19, the European Medicines Agency (EMA) began to review the drug for emergency use authorization (EUA). Meanwhile, the company’s rivals Moderna and...
