STOCKHOLM, Sweden — BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to exidavnemab for the treatment of Multiple System Atrophy (MSA), providing incentives for the development of treatments for rare diseases with a high...
treatment News
New Haven, Conn. — BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI) (the “Company” or “Bioasis”), a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factor and a differentiated, proprietary xB3 ™ platform for delivering therapeutics across the blood-brain barrier (“BBB”) and the treatment of central...
TEMPE, AZ – BioCareSD, a leading specialty distributor for orphan, rare and ultra-rare diseases, announced today that they have added RENFLEXIS, a biosimilar to REMICADE, to their ever-expanding portfolio of therapies. “BioCareSD is excited to have been selected as a specialty distributor of such an important therapy for countless patients...
WUXI, China — BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor selective antagonist SC0062, currently under development for chronic kidney disease (CKD),...
ANAHEIM, Calif. – BioCorRx Inc. (OTCQB: BICX), a developer of innovative treatment programs for substance use and related disorders, today announced that its subsidiary BioCorRx Pharmaceuticals Inc., a clinical-stage biopharmaceutical company, has been granted a new patent by the United States Patent and Trademark Office (USPTO). The USPTO has issued...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Japanese National Health Insurance System (NHI) has approved the addition of oral, once-daily ORLADEYO™ (berotralstat) to the NHI drug price list on April 21, 2021. Oral, once-daily ORLADEYO was approved in Japan in January 2021 for prophylactic treatment...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) for the prevention of recurrent attacks in patients with hereditary angioedema (HAE) 12 years and older. To support commercialization efforts...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the designs for REDEEM-1 and REDEEM-2, two upcoming pivotal trials with its oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 is a randomized, open-label, active, comparator-controlled comparison of the efficacy and safety of BCX9930...
RESEARCH TRIANGLE PARK, N.C. — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12...
RESEARCH TRIANGLE PARK, N.C.— BioCryst Pharmaceuticals, Inc. today announced that data from the open-label extension (OLE) of the APeX-2 trial of oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) in patients 12 years and older have been published online by the Journal of Allergy and Clinical...