News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
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...
SparingVision will acquire GAMUT Therapeutics, the biotech behind a gene-independent approach to treat the later stages of rod-cone dystrophies such as retinitis pigmentosa (RP).
The European Union has exercised its option, under a previous agreement, to order 100 million additional doses of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty.
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the plant.
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...