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September 28, 2020
Steven J. Lynn previously held positions at FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs.
The board will work with Lonza’s research scientists and product managers to offer guidance on the company’s research and scientific programs for in vitro ADME and toxicology testing.
GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility.
September 24, 2020
FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.
A strategic serialization partnership has been announced by advanco and Syntegon, aimed at tackling the global issue of counterfeit drugs.
Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.
The facility for early-phase clinical biologics formulation development and drug product fill/finish services will be integrated with an existing Catalent facility nearby.
The radiopharmaceutical CDMO is building a new cGMP facility in Springfield, NJ.
September 23, 2020
The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).
CMDO Piramal Pharma Solutions held a grand opening at a facility they acquired in Sellersville, PA.