FDA Starts 2015 As It Plans To Go On: A Spate Of Approvals, A Full Slate Of Possibilities
This article was originally published in Pharmaceutical Approvals Monthly
With more than 40 novel agents under FDA review – and seven approvals already – prospects are good for 2015 to be another stellar year for new molecular entity and novel biologic approvals. Supplemental indications with “breakthrough” designations and the first biosimilars could challenge the primacy of NMEs in the approval narrative.
You may also be interested in...
Lung cancer will be a battleground in 2015, as the big pharma oncology players jockey for position in immuno-oncology while filling out their targeted therapy portfolios.
After an impressive commercial run for Biogen Idec, with four drug launches in two years, it’s up to R&D to deliver more innovative medicines. The bar is high in the areas of neurology Biogen is exploring; Chief Medical Officer Alfred Sandrock discussed the company’s R&D momentum in a recent interview.
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.