CLEVELAND, Ohio — NovelMed today announced that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). NM5072 is being developed for PNH patients in the United States...
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CLEVELAND, Ohio — NovelMed Therapeutics Inc., a clinical-stage biopharmaceutical company specializing in alternative pathway (AP) complement-mediated therapies, today announced two major milestones in the clinical development of Ruxoprubart (NM8074) for Paroxysmal Nocturnal Hemoglobinuria (PNH). The company has received regulatory clearance to initiate a Phase II study for the subcutaneous (SC)...
CLEVELAND, OHIO— NovelMed Therapeutics, Inc. today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Ruxoprubart, an alternative pathway (AP) blocker anti-Bb antibody, for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). FDA’s recognition of Ruxoprubart as an orphan drug for PNH underscores its potential...
NoviSystems, a Research Triangle-area company that empowers data-driven decision making, has commercially launched Fusion Analytics, its platform to help hospitals, drug manufacturers and other complex businesses gain answers and insights that can save them time and money. NoviSystems has assembled a team of senior advisers to help apply Fusion Analytics...
PLAINSBORO, N.J. — Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone.1 Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature...
DUBLIN, Ireland — Prothena Corporation plc (NASDAQ:PRTA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to coramitug, a potential best-in-class amyloid depleter antibody currently in Phase 3 development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Fast Track Designation is intended to...
Bagsværd, Denmark – Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an update of the Alhemo® (concizumab) label to include the treatment of severe hemophilia A and moderate or severe haemophilia B without inhibitors. “If...
BAGSVÆRD, Denmark and PLAINSBORO, N.J. — Today, Novo Nordisk announced Mim8 (denecimig) has been submitted for review to the U.S. Food and Drug Administration (FDA) through a Biologics License Application (BLA), a formal request to evaluate a biologic medicine. Denecimig is an investigational, next-generation bispecific antibody Factor VIIIa (FVIIIa) mimetic,...
LEXINGTON, Mass. – Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) today announced that it has entered into a definitive agreement with Novo Nordisk under which Novo Nordisk will acquire Dicerna, a biopharmaceutical company focused on the development of investigational ribonucleic acid interference (RNAi) therapeutics, for $38.25 per share in cash, which represents a total equity value...
Novo Nordisk has entered into a definitive agreement to acquire Dicerna Pharmaceuticals (Dicerna) for a total equity value of approximately USD 3.3 billion. The acquisition of Dicerna’s ribonucleic acid interference (RNAi) platform is a strategic addition to Novo Nordisk’s existing research technology platforms and supports the strategy of using a...