Tag: drug development

Company milestone aligns with June’s Men’s Health Month and ongoing capital raising initiative

CAMBRIDGE, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the initiation of dosing in the global clinical study, PROMINENT. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with primary membranous nephropathy (PMN). PROMINENT is designed to enroll approximately 180 adults with PMN and expected to readout in 2029. PMN is a severe antibody-mediated disease of the kidney that is a leading cause of nephrotic syndrome and carries a significant risk of kidney failure.

BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform’s continuous innovation and PathAI’s commitment to delivering enhanced capabilities as the product evolves.

CAMBRIDGE, Mass., June 27, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced new data that reinforce the clinical impact of nusinersen across a broad spectrum of individuals affected by spinal muscular atrophy (SMA). These latest findings from Part C of the DEVOTE trial evaluating a higher dose regimen of nusinersen and the NURTURE trial which evaluated the approved 12 mg regimen (SPINRAZA^®) in clinically presymptomatic SMA were presented at the SMA Research & Clinical Care Meeting hosted by Cure SMA in Anaheim, Calif. Biogen’s applications for the higher dose regimen of nusinersen are currently under review in the U.S., Europe, Japan and other global markets. The higher dose regimen of nusinersen comprises a more rapid loading regimen – two 50 mg doses 14 days apart – and a higher maintenance regimen – 28 mg every four months.

ProFound to receive $25M in upfront and near-term milestone payments with a potential value from downstream milestones of $750M per target

LIKMEZ™ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL re-launched and commercial sales ongoing