Keeping Track: Neurology And Breakthroughs Stay In Spotlight As US FDA Approves Radicava, Imfinzi; TaiMed Submits Ibalizumab
The latest drug development news and highlights from our Performance Tracker.
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The Astellas-partnered drug did not reach statistical significance on any FORTITUDE-ALS endpoints, but clinically significant results over time justify a longer Phase III study that's likely to enroll ALS patients with a faster rate of disease progression.
Early engagement with US payers suggests openness to covering a liquid form of riluzole, because the tablet version is proven, but it's impossible to take for many ALS patients, says Italfarmaco subsidiary ITF Pharma.
Keeping Track: FDA Approves Novel HIV Treatment, New Dosing Regimen For Opdivo; Another Rare Pediatric Disease Designation For Prometic
The latest drug development news and highlights from our US FDA Performance Tracker.