For Novartis' Generic Advair, Another 18 Months Was Too Far Into The Unknown
Company did not kill its development program because of US FDA feedback, but the experience seems to be another lesson in the difficulty in gaining approval for complex generics.
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Zolgensma Stands Out In Strong Q4 For Novartis
CEO Vas Narasimhan is confident the Swiss major's gene therapy for spinal muscular atrophy will outperform present and future rivals – Biogen's Spinraza and Roche's risdiplam, respectively – as "we have a better profile simply because we are a one-time therapy."
Complex Generic Approval Delays Getting Congressional Attention
US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.
Hikma Addresses Advair Issues In US
Hikma has submitted a response to the US FDA addressing all outstanding deficiencies in its application for a generic version of GlaxoSmithKline’s Advair Diskus.