Biogen/Ionis’ Tofersen Wins Accelerated Approval In ALS Subgroup – A Significant But Narrow Precedent
US FDA designates ongoing ATLAS trial in presymptomatic individuals with SOD1 mutation as confirmatory study. ‘Classic Biogen’ approval is first in ALS under the expedited pathway and could lead to more drugs reaching market on basis of a reduction in plasma neurofilament light chain concentration.
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Priya Singhal, head of development, spoke with Scrip about the company’s R&D restructuring, readouts coming from the culled pipeline and how Biogen is thinking about adding to it in the future.
The European Medicines Agency is this week due to decide whether to back pan-EU marketing authorization for five new medicines, including a combination antibiotic product and a drug for chemotherapy-induced neutropenia.
The European Medicines Agency is this week due to decide whether to back pan-EU marketing authorization for seven products, including three for orphan indications.