CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) – announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE). Litifilimab is a first in-class, humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2)....
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CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) announced positive results from the Phase 2 part of the AMETHYST Phase 2/3 study (Part A) of litifilimab in people living with cutaneous lupus erythematosus (CLE). Litifilimab is the first humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2), which...
CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a...
Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA) Interim Phase 1 data show children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function...
NEW HAVEN, Conn. – Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), announced the enrollment of the first patient in a Phase 1a/1b trial in Multiple Myeloma using the ARM, BHV-1100, in combination with autologous cytokine induced memory-like (CIML) natural killer (NK) cells and immunoglobulin (Ig) to target and kill multiple...
NEW HAVEN, Conn. and LEUVEN, Belgium – Biohaven Therapeutics Ltd., a subsidiary of Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), along with CD3 and LICR at KU Leuven, announced that they have entered into an exclusive global license and research agreement to develop and commercialize first-in-class TRPM3 antagonists to address...
LUND, SE – BioInvent International AB (“BioInvent”) (NASDAQ Stockholm:BINV), a leader in the discovery of novel immune-modulatory antibodies, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of ovarian cancer in combination with pembrolizumab. “Receiving FDA Fast...
LUND, Sweden – BioInvent International AB (“BioInvent”)(Nasdaq Stockholm: BINV)(STO:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has adopted a positive opinion for Orphan...
TEL AVIV, Israel — BioLineRx Ltd., a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been dosed in the l evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies...
TEL AVIV, Israel – BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive top-line results from the Company’s GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this...