Prestige BioPharma Ltd. (hereinafter “Prestige BioPharma”) today announced that the European Medicines Agency (EMA) Orphan Drug Commission (COMP) has granted a positive opinion for an Orphan Drug Designation (ODD) status to its first-in-class anti-PAUF monoclonal...
EMA
Category
BioNTech & Pfizer’s BNT162b2 Now Under Rolling Submission Status by EMA: Means COVID-19 Vaccine Could Get Approved Faster
The COVID-19 vaccine candidate known as BNT162b2 may be getting closer to registration (e.g. approval) as the European Medicines Agency (EMA) has accepted the initiation of a rolling submission from partners Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX), the...
European Medicines Agency Initiates Rolling Review of AZD1222 While FDA Puts Trial on Hold for a Different Review
The European Medicines Agency (EMA) human medicines committee (CHMP) reports publicly the first ‘rolling review’ of a COVID-19 vaccine starting with AstraZeneca’s AZD1222 or the “Oxford” vaccine. This committee is investigating the first batch of data on the vaccine...
Importance of Drug Regulators Sharing Real-World Data Worldwide to Target COVID-19: Enter ICMRA
The European Medicines Agency (EMA)—the regulatory body controlling drug rules in Europe—issued a press release announcing an agreement among drug regulators to cooperate on observational research (real-world data) focusing on medicines used in clinical practice...
Drug Study Report Transparency vs. Industry Interests: A Battle Building in Europe
Europe’s biopharma sponsors, or at least some of them, are resisting transparency when it comes to the proactive publishing of study reports upon completion of the study. The European Medicines Agency (EMA) gradually improved its transparency policy. With Brexit and...