FDA Label Change On PML Threatens Gilenya’s Sales Ascent
This article was originally published in The Pink Sheet Daily
FDA convinced by lack of prior immunosuppressant use in two cases detected in routine monitoring.
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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.
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.
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.