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May 07, 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.
Researchers from the United Kingdom, have identified a new additive manufacturing method that enables the 3D printing of medicine in highly porous structures.
Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.
Solentim has announced the expansion of its European operations, with the establishment of a new entity in Ireland.
Vectura and Inspira Pharmaceuticals have joined forces to develop a potential inhaled therapy for COVID-19.
May 06, 2021
FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.
Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.
Catalent has acquired Promethera Biosciences’ cell therapy manufacturing subsidiary, which includes a 32,400 ft2 facility in Gosselies, Belgium.
ISPE’s virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.