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February 17, 2022
Thermo Fisher Scientific is expanding its Millersburg, Penn., site with a $40 million investment to support increased production of single-use technology for critical vaccines and biologics.
The commercialization and licensing deal will see Biogen commercialize Xbrane’s Xcimzane, a proposed biosimilar for CIMZIA (certolizumab pegol).
ONK will receive non-exclusive rights to Intellia’s proprietary ex-vivo CRISPR/Cas9 technology in the development of five allogeneic NK cell therapies.
ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.
FDA has granted Eli Lilly and Company’s bebtelovimab, a monoclonal antibody designed for treatment of COVID-19, an Emergency Use Authorization (EUA).
The deal between ProBioGen and AstraZeneca will allow AstraZeneca to use ProBioGen’s GlymaxX technology.
February 16, 2022
Guidance published during the pandemic has been updated to include content requirements for summary safety reports.
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.