BioSpace News Archive

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• Press Releases

  EMA Grants PRIME Designation to TolerogenixX’s MIC-Lx Therapy for Donor-Specific Immune Tolerance in Kidney Transplantation

  March 11, 2026

   · 

  1 min read
• Press Releases

  Commit Biologics appoints serial biotech founder as new CEO to take complement-powered immune engagers into the clinic

  March 11, 2026

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  4 min read
• Press Releases

  Gene Therapy for Duchenne Muscular Dystrophy: Genethon Confirms Two-Year Efficacy in Patients Treated with Its Drug Candidate GNT0004 at Therapeutic Dose in the First Phase of Its Clinical Trial

  March 11, 2026

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  4 min read
• Press Releases

  Chiesi and Bespak Partner to Advance Carbon Minimal Inhaler Production With UK Manufacturing Site

  March 11, 2026

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  6 min read
• 

  Duchenne muscular dystrophy

  Capricor Shares Rise as FDA Sets August Decision Date for Rejected Duchenne Therapy

  Capricor Therapeutics’ deramiocel was rejected in July 2025, potentially caught between Nicole Verdun, a former top biologics regulator at the FDA, and outgoing Vinay Prasad, director of the Center for Biologics Evaluation and Research.

  March 11, 2026

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  2 min read

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  Tristan Manalac
• Press Releases

  Validation of Patient-Reported Outcomes in the On-Demand Treatment of Hereditary Angioedema Attacks Published in Clinical Reviews in Allergy & Immunology

  March 11, 2026

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  10 min read
• 

  GLP-1

  Novo Hit With FDA Warning Letter for Unreported Ozempic Safety Signals

  Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report.

  March 11, 2026

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  2 min read

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  Tristan Manalac
• Press Releases

  60 Degrees Pharmaceuticals Announces All Patients Cured of Babesiosis After Tafenoquine Treatment in Expanded Use Clinical Trial

  March 11, 2026

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  10 min read
• Press Releases

  Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Business Updates

  March 11, 2026

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  19 min read
• Press Releases

  Arvinas to Present Phase 1 Data for ARV-102, a PROTAC LRRK2 Degrader, in Oral Session at the 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders

  March 11, 2026

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  5 min read