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February 16, 2022
The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.
The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.
The agency recommended 53 new active substances in 2021, up 35% from 2020.
February 15, 2022
While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.
February 11, 2022
Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.
EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.
EMA has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre.
February 10, 2022
Sartorius Stedim Biotech has completed the acquisition of the chromatography equipment division of Novasep.
The European Patent Office has granted another patent to Salipro Biotech, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.
CGT Catapult has partnered with MICA Biosystems to advance MICA’s regenerative medicine technology to the UK’s MHRA.