PML Case With Roche's Ocrevus, Link Unlikely
Executive Summary
A German case of PML in a patient treated with Ocrevus, but who was also previously treated with Tysabri, threatens to take the gloss off Roche’s new multiple sclerosis therapy.
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The European Medicines Agency has confirmed the recommendations of its Pharmacovigilance Risk Assessment Committee (PRAC) to update the product information for the sodium-glucose co-transporter-2 (SGLT2) inhibitors, used to treat type 2 diabetes, to include diabetic ketoacidosis as a rare adverse reaction. The EMA has also recommended temporarily stopping SGLT2-inhibitor use in patients who are in hospital because of serious illness or are undergoing major surgery.
Conditional European approval for Fampyra for MS walking disability
Following a reluctant recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in May, the European Commission has now conditionally approved Biogen Idec and Acorda Therapeutics' Fampyra (sustained-release fampridine), to improve walking in adult patients with multiple sclerosis (MS) who have walking disability.
Pipeline Watch: Phase III Readouts in Wilson Disease, Parkinson's Disease And COVID-19
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.