Author Archives: Patricia Inacio PhD

Australia Offers Subsidized Coverage of Spinraza for Pre-symptomatic Children With SMA

Australia is expanding access to Spinraza (nusinersen) to children and infants with severe spinal muscular atrophy (SMA) who have not yet developed symptoms, a period when the medicine is likely to benefit patients the most. Effective Dec. 1, Biogen’s Spinraza will be added to the Pharmaceutical Benefits Scheme (PBS) for the…

Plans Advance for Biomarkers Panel to Assess Drug-induced Skeletal Muscle Injury

A new panel of four safety biomarkers to assess acute drug-induced skeletal muscle injury in Phase 1 clinical trials has received a positive response from the U.S. Food and Drug Administration (FDA). The new biomarker panel is particularly important for companies developing therapies for patients with neuromuscular diseases, including…

Asuragen’s Diagnostic Test for SMA Approved for Use in Europe

Asuragen’s diagnostic test for the analysis of genes associated with spinal muscular atrophy (SMA) — called AmplideX SMA Plus Kit — was given the European CE mark, approving it for commercial use, the company announced. The designation means the AmplideX kit complies with the…