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Tag: safety profile

New Data for Nusinersen Underscore Biogen’s Commitment to Advancing Clinical Research to Improve Outcomes in SMA

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.

UCB announces positive results from GEMZ Phase 3 study of fenfluramine in CDKL5 deficiency disorder

Phase 3 study met primary and most key secondary clinical endpointsThis marks the third developmental and epileptic encephalopathies (DEE) population for fenfluramine with positive phase...

Cellarity Initiates Phase 1 Clinical Study of CLY-124, a First-in-Class Globin-Switching Oral Medicine for the Treatment of Sickle Cell Disease

Initiation follows successful IND clearance based on preclinical data package indicating robust increase in fetal hemoglobin with no cytotoxicity Novel Globin-Switching mechanism derived from...

BioCity’s ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria

Second BTD Recognition Highlights Compound's Potential as Next-Generation Broad-Spectrum Renal TherapySHANGHAI, June 25, 2025 /PRNewswire/ -- BioCity Biopharma ("BioCity") announced today that the Center for...

CARsgen Therapeutics Announces NDA Acceptance of Satri-cel by China’s NMPA

SHANGHAI, June 25, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that...

ProZenith Ingredients Researched: The Science Behind the Popular Formula

Plant-Based Ingredients, Scientific Research, and Mineral Synergy Come Together in This Modern Approach to Natural Weight Support
Plant-Based Ingredients, Scientific Research, and Mineral Synergy Come Together in This Modern Approach to Natural Weight Support

Wall Street Eyes Breakout Cancer Therapies Amid Soaring Drug Prices

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 24, 2025 /PRNewswire/ -- Equity Insider News Commentary – Rising rates of cancer...

Wall Street Eyes Breakout Cancer Therapies Amid Soaring Drug Prices

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 24, 2025 /PRNewswire/ -- Equity Insider News Commentary – Rising rates of cancer...

Wall Street Eyes Breakout Cancer Therapies Amid Soaring Drug Prices

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 24, 2025 /CNW/ -- Equity Insider News Commentary – Rising rates of cancer...

SRPT STOCK LOSS: Sarepta Therapeutics, Inc. Shareholders are Alerted of Ongoing Securities Fraud Investigation — Contact BFA Law (NASDAQ:SRPT)

Sarepta Therapeutics, Inc. investors that lost money are notified to contact BFA Law about its ongoing securities fraud investigation.

Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy

Orally administered treatment was well tolerated, with early signs of clinical activityIn models of non-proliferative diabetic retinopathy (NPDR), danegaptide has demonstrated protection against retinal...

Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy

Orally administered treatment was well tolerated, with early signs of clinical activityIn models of non-proliferative diabetic retinopathy (NPDR), danegaptide has demonstrated protection against retinal...

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog...

Phase 2 data highlights best-in-class potential of dual GLP-1R/GIPR agonist BGM0504 for weight management and metabolic risk reduction in individuals with type 2 diabetes...

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog...

Phase 2 data highlights best-in-class potential of dual GLP-1R/GIPR agonist BGM0504 for weight management and metabolic risk reduction in individuals with type 2 diabetes...

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