In the Japanese Phase 3 study, 0% mortality was reported over the 30-month treatment period and acoramidis was well-tolerated The approval was based on a Japanese Phase 3 study and the global ATTRibute-CM Phase 3 trial, which demonstrated the most rapid benefit seen in any Phase 3 study of...
treatment News
MENLO PARK, Calif. — BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is pleased to announce a global collaboration with Janssen Research & Development, LLC, a Johnson & Johnson company (Johnson & Johnson), in the AZALEA Phase 3...
ATLANTA, Georgia — UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only approved medicine to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),2 continued to be generally well tolerated, and demonstrated sustained symptom...
HOUSTON, Texas — Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002...
GUANGZHOU, China — Bio-Thera Solutions, Ltd. today announced the publication of the Phase I clinical study results for BAT4406F, an ADCC-enhanced fully humanized anti-CD20 monoclonal antibody in Chinese patients with neuromyelitis optica spectrum disorders (NMOSD) in the journal CNS Neuroscience & Therapeutics. Neuromyelitis optica spectrum disorder (NMOSD) is a rare...
NORTH BRUNSWICK, N.J — BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce site recruitment for BTI-203, a Phase 2 study of recombinant human gelsolin (rhu-pGSN) for the treatment of Acute Respiratory Distress Syndrome (ARDS) (NCT05947955). The study, A Phase...
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...
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),...
