FDA Label Change On PML Threatens Gilenya’s Sales Ascent
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA convinced by lack of prior immunosuppressant use in two cases detected in routine monitoring.
You may also be interested in...
Rare Disease Roundtable: Dealing With Pricing Pressure
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.
Rare Disease Roundtable: How Rare Is Too Rare?
Part 1: Execs from rare disease-focused companies weighed in on investor sentiment during a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference.
Can-Fite Plans Phase III For Namodenoson, Despite Liver Cancer Trial Failure
Patients with the most severe type of disease were all randomized to treatment with the study drug, which may have had a negative impact on outcome, the Israeli company suggested.