The European Commission (EC) has authorised the world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis. The authorisation for the subcutaneous (SC) formulation now applies to all previously approved indications for the intravenous (IV) formulation in adults including: ankylosing spondylitis (AS),
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Critical Path Institute (C-Path) announced that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the FDA issued a positive response to the Letter of Intent (LOI) developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC), for a panel of four safety biomarkers of
The MHRA has granted Alnylam’s lumasiran a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). The decision will allow patients with the ultra-rare disease primary hyperoxaluria type 1 (PH1) access to the drug before its official approval by the European Commission. PH1 is an ultra-rare orphan disease affecting around 90 patients in