Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
The European Medicines Agency’s safety committee (PRAC) says a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen: but says the benefit-risk analysis for the vaccine remains...
The EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.
The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...
The European Commission has reached an agreement with CureVac for up to 405 million doses of its mRNA-based COVID-19 vaccine candidate: representing the biggest COVID-19 vaccine deal the Commission has inked so far.
Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.
The difficulties in the manufacture of CAR-T treatments have become increasingly understood as the breakthrough technology has been commercialised, but Kite’s head of medical affairs says its process is nearly flawless.