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Specialists Consulting for FDA & EMA Orphan Drug Development and Designations for Rare Diseases
A US-based corporation that operates as a not-for-profit, BioPharma Global offers FDA & EMA regulatory affairs and a complete suite of professional services to address the needs of emerging and growing biotech companies globally dedicated to rare disease research.
Clinical Network Services (CNS), an international clinical and regulatory service group, and BioPharma Global announced they have signed a cooperative partnership agreement. Read more here.
BioPharma Global News and Notes
AstraZeneca and Merck & Co., Inc. announced the US FDA has granted Orphan Drug Designation for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1. The potential benefit of selumetinib... READ MORE
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of... READ MORE
Abeona Therapeutics Inc., a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the FDA has granted Orphan Drug Designation (ODD) to... READ MORE
FDA Commissioner Scott Gottlieb released a statement regarding the Administration’s request for new FDA funding to “promote innovation and broaden patient access through competition.” In the statement, he emphasizes that new scientific opportunities... READ MORE