Acorda To FDA: “Back At You” – But Fampridine-SR Approval Still Not Certain
This article was originally published in The Pink Sheet Daily
Executive Summary
Refusal to file letter gets quick response, but could prove long-term curse.
You may also be interested in...
FDA’s Refusal-To-File Slows Acorda’s Promising Niche MS Drug
Firm may need to refile NDA for mobility-boosting Fampridine-SR.
Another Hybrid License Deal: Chiesi Buys Majority Stake In Cornerstone
In a creative deal that echoes the strategic tie-up last year between Infinity and Mundipharma, Italian giant Chiesi Farmaceutici is buying a majority stake in Cornerstone Therapeutics, which gets $15.5 million along with U.S. rights for 10 years to Chiesi's marketed lung surfactant Curosurf
Another Hybrid License Deal: Chiesi Buys Majority Stake In Cornerstone
With a would-be competitor from Discovery Labs stalled at FDA, approved lung surfactant Curosurf sits at the center of equity, cash tie-up.