Keeping Track: US FDA Approves Pfizer’s Vyndaqel, Jacobus’ Ruzurgi, But Nixes Acacia’s Barhemsys Again
The latest drug development news and highlights from our US FDA Performance Tracker.
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Pfizer is one of 10 pharma companies that have reached settlements with the US Department of Justice over their relationships with co-pay assistance foundations. It now seeks a declaratory judgement that proposed programs for its heart drug tafamidis do not violate the anti-kickback statute.
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.