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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
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eisai’s Lenvima (lenvatinib), in combination with Merck’s Keytruda (pembrolizumab), to treat patients with advanced renal cell carcinoma (RCC). The FDA... READ MORE
Avadel Pharmaceuticals plc has been granted Orphan Drug Designation from the US Food and Drug Administration (FDA) for FT 218 for the treatment of narcolepsy. FT 218 is a once-nightly formulation of sodium... READ MORE
The FDA granted Shire’s Phase III-stage drug maribavir (SHP620) Breakthrough Therapy Designation for treating cytomegalovirus (CMV) infection and related disease in transplant patients who are resistant or refractory to previous therapy. Maribavir is... READ MORE
Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications, today announced that investigators from the National Institutes of Health (“NIH”) have relayed to the Company positive... READ MORE