Keeping Track: US FDA Approves Pfizer’s Vyndaqel, Jacobus’ Ruzurgi, But Nixes Acacia’s Barhemsys Again
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
You may also be interested in...
Pfizer Switches To Offense In Charity Co-Payment Suit Against HHS
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.
FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims
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).
Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.