BETHESDA, Md. – The Cystic Fibrosis Foundation affirmed its support for the PASTEUR Act, a bipartisan proposal that, if passed, will support the development of new antibiotics and promote appropriate use of existing ones. The organization issued the following statement: “New solutions are needed now to bring novel antibiotics into...
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Washington, DC – Rare diseases, by their very nature, don’t fit the mold—so neither should the trials for therapies designed to treat them nor the regulatory process to approve them. This was the tone set during a recent panel discussion where Peter Marks, director of the FDA’s Center for Biologics...
Basel, Switzerland – Some pathogens hide inside human cells to enhance their survival. Researchers at the University of Basel, have uncovered a unique tactic certain bacteria use to spread in the body without being detected by the immune system. In their study, they reveal the crucial role of a bacterial...
BEERSE, BELGIUM — Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved a Type II extension of indication for RYBREVANT®▼ (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed), for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with epidermal...
PARAMUS, N.J. — NS Pharma, Inc., a subsidiary of Nippon Shinyaku Co., Ltd, announced today that the European Commission (EC) has granted orphan drug designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic granulomatosis with polyangiitis (EGPA). The orphan drug designation by the EC...
YONGIN, South Korea — GC Biopharma Corp. announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its intracerebroventricular (ICV) Enzyme Replacement Therapy (ERT) candidate, GC1130A, designed for Sanfilippo Syndrome type A (mucopolysaccharidosis type IIIA), developed in collaboration with Novel Pharma. GC1130A has previously achieved notable...
HOUSTON, TX – Moleculin Biotech, Inc., (Nasdaq: MBRX), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Annamycin for the treatment of AML. Annamycin is the Company’s next-generation anthracycline...
TOKYO, Japan — Astellas Pharma Inc. President and CEO Naoki Okamura contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium. The Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted...
RAHWAY, N.J. – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer...
NEW YORK, NY — Mesoblast Limited, a leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) a Rare Pediatric Disease (RPD) Designation following submission of results from the randomized controlled trial in...