FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.
It doesn't appear there is going to be a quick fix to get Mylan NV's generic version of GlaxoSmithKline PLC's AdvairDiskus (fluticasone/salmeterol) to market. President Rajiv Malik told investors May 10 that the US FDA's complete response to its ANDA for an interchangeable version of Advair was deemed a "major CRL."
The company's first quarter sales and earnings release was the first chance investors have had to hear publicly from management...
Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.
The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.
In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.
The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.
The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.
The US firm was already looking to compete in ulcerative colitis, but now expands its ambitions by moving into rheumatoid arthritis as well.
Wales-based group launches with $140m series A.
