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Latest From Eisai Co., Ltd.

Are Jubilant Pharmova’s US Plant Closure, FDA Observations At Canada Unit A Concern?

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

Manufacturing Strategy

US FDA Wants Advice About Advisory Committees: Try Having Some?

The FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

Advisory Committees Drug Review

Are Jubilant Pharmova’s US Plant Closure, FDA Observations At Canada Unit A Concern?

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits. Scrip takes a look at the likely impact.

Manufacturing Business Strategies

Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

Europe Approvals
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