Novartis Respiratory Franchise Sits On FDA Launch Pad; Can It Achieve Orbit?
Executive Summary
EXPEDITION clinical program seems to satisfy U.S. requirements for firm’s COPD bronchodilators; now all Novartis needs is approval, some clinical differentiation – and perhaps a marketing partner.
You may also be interested in...
FDA Approves GSK’s Anoro Ellipta, The First LABA/LAMA Combination
FDA approved GSK’s Anoro Ellipta as the first LABA/LAMA combination product in the U.S. for the maintenance treatment of COPD Dec. 18, positioning GSK to launch a second respiratory product months after launching Breo Ellipta.
Novartis Once-Daily COPD Combo Safe, Effective And Ready For Filing – Everywhere But In The U.S.
Novartis released results from “an unprecedented package of data” to be filed with European regulators for its novel once-daily dual bronchodilator combination of the LABA indacaterol and the LAMA NVA237 (glycopyrronium) for COPD at the European Respiratory Society Congress, but FDA has already made clear that it wants to see trials with once- and twice-daily dosing at lower strengths than those tried in the European program, and those studies have yet to launch.
Anjarium To Pioneer Next-Generation Non-Viral Gene Therapies
Emerging Company Profile: Switzerland-based Anjarium Biosciences AG has successfully raised $61m in a series A financing that will fund expansion of its novel proprietary platform and development of a nascent pipeline of non-viral gene therapies.