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April 25, 2022
EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.
April 22, 2022
FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”
FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.
April 21, 2022
The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.
April 20, 2022
Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.
Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.
New guidance from FDA and legislation from Congress promote clinical trial diversity.
April 18, 2022
AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.
Thermo Fisher Scientific has launched its first GMP-manufactured Cas9 protein for clinical genome editing research.