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Lupin is no stranger to FDA rebukes. After facing accusations of “inadequate” manufacturing operations writ large last summer, the generics juggernaut is apparently yet to clean up its act.
India’s Zydus Lifesciences is in the FDA’s crosshairs once again, this time for a trio of unnamed violations at an injectables facility.
Catalent received an FDA write-up for its syringe filling facility in Belgium, BioProcess International reports, adding that it is "allegedly" the culprit behind supply challenges for Novo Nordisk’s obesity med Wegovy.
Biogen and Eisai have started an FDA rolling submission for another Alzheimer's disease drug. Samsung Biologics' long-term partnership with Roche has grown in value. Otsuka has penned a near-$1 billion deal for four Sunovion neuropsychiatric candidates. And more.