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Latest From Purdue Pharma L.P.

Deal Watch: Roche Partners With Jnana On Cellular Metabolism Approach To Disease

Pharma and the US biotech will target key regulators of cellular metabolism with focus on immune and neurological disorders. Royalty Pharma buys portion of PTC’s royalty rights to risdiplam, under development at Roche.

Deals Business Strategies

Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach

With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.

Drug Review Review Pathway

Swift Pace Of Accelerated Approval Submissions Suggests Strong Constituency For US FDA Program

FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.

Review Pathway Drug Review

Keeping Track Of US FDA Decisions: COVID-Induced Complete Response Letter For Contepo; Safety Sinks Abicipar Pegol; Approvals For Fintepla and Gimoti

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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