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Novartis AG

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Latest From Novartis AG

Gene Therapy Approvals By US FDA Could Double In 2020

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.

Gene Therapy Drug Review

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Approvals Drug Review

Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications

Accelerated approval in epithelioid sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.

Approvals Business Strategies

New CEO Brett Monia Takes The Lead As Ionis Prioritizes Non-Partnered Programs

Monia told Scrip at the J.P. Morgan Healthcare Conference that the company will be more selective about partnerships going forward and build commercial capabilities to market Ionis-owned drugs.

Leadership Business Strategies
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