TORONTO, Ontario — Biomind Labs Inc. (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological disorders by targeting the drivers of disease, today announced the successful conclusion of the Phase 2 clinical trial of its...
treatment News
CAMBRIDGE, Mass. and NESS ZIONA, Israel — BiomX Inc., a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that its phage cocktail, BX004, has been granted Orphan Drug Designation (“ODD”) by the United States Food and Drug Administration (“FDA”), for the treatment...
Peer-reviewed publication from Iqbal, et al. describes the multi-site evaluation of optical genome mapping (OGM) for postnatal genetic disorders with 404 samples and shows:
Concordance of OGM against various standard of care (SOC) methods –99.5% [399 out of 401 samples]
First-pass success rate for OGM – 90.2% [369 out of 409 samples]
Overall success rate – 98.8% [404 out of 409 samples]
Inter- and intrasite repeatability –100%
Pre-print publication from Broeckel, et al. describes the multi-site evaluation of OGM in an additional 560 unique samples, with a total of 749 unique samples to-date from 1,037 datapoints and shows:
Concordance for all combined samples against SOC methods – 99.6% [746 out of 749 samples]
For a subset of 79 prospectively collected samples from patients suspected of a genetic disorder, SOC had reportable findings in 19 cases [24%]; OGM had reportable findings in 27 cases [34%], corresponding to a 42% increase in the number of cases with reportable findings when OGM was used
For another subset of cases consisting of 135 retrospectively collected samples from patients suspected of autism spectrum disorders (ASD), SOC found reportable variants in 63 samples [46%]; OGM identified reportable variants in 83 samples [61%] corresponding to a 32% increase in the number of cases with reportable findings when OGM was used
IRVINE, Calif. – Bioniz Therapeutics, Inc., (“Bioniz”), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, today announced the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer....
MAINZ, Germany and SHANGHAI, China – BioNTech SE (Nasdaq: BNTX) and Duality Biologics (Suzhou) Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for BNT325/DB-1305 for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who...
VANCOUVER, BC – BioNxt Solutions Inc. is pleased to report that the comparative pharmacokinetic (PK) study for its oral dissolvable film (ODF) based proprietary Cladribine product for the treatment of Multiple Sclerosis (MS) has been completed. Results will be reported by the Company when available. The PK study closely follows...
PARIS – The European Medicines Agency has issued a marketing authorisation for OZAWADE™ (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea in adults. OZAWADE™ is indicated to improve wakefulness and reduce EDS in adult patients suffering from obstructive sleep apnoea (OSA) whose EDS...
Paris — The European Medicines Agency has just granted an extension of the indication for the marketing authorisation for WAKIX® (pitolisant), which is now indicated for the treatment of narcolepsy in children from the age of 6 years, with or without cataplexy. Narcolepsy is a rare disease, which originates in...
Washington, DC – In 2023, cell and gene therapy saw an unprecedented surge with seven FDA approvals, and this year, an even greater number of these treatments could reach the market. So far in 2024, the regulator has given the green light to three new CGTs, and at least seven...
Washington, DC – The March approval of ITF Therapeutics’ Duvyzat marked the third new FDA-approved treatment in 10 months for Duchenne muscular dystrophy (DMD), a genetic disorder that causes progressive muscle weakness and degeneration. In June 2023, the regulator greenlit Sarepta’s Elevidys as the first-ever gene therapy for DMD. That...