BALA CYNWYD, Pa. — Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, announced preliminary top-line data from the 25 mg cohort of its Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 in participants with Friedreich’s ataxia (FA). Participants in...
treatment News
MARLBOROUGH, Mass. – Boston Scientific Corporation (NYSE: BSX) announced positive data from the TARGET study of the TheraSphere™ Y-90 Glass Microspheres (TheraSphere) – a type of radioembolization comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90) – during a late-breaking clinical trial presentation at the annual scientific meeting...
MARLBOROUGH, Mass. – Data presented at hotline and late-breaking trial sessions today at the EuroPCR 2021 congress demonstrated positive procedural performance, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI), of the Boston Scientific (NYSE: BSX) ACURATE neo2™ Aortic Valve System within the investigator-initiated Early neo2 Registry...
WALTHAM, Mass. — Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the approval and launch of highly anticipated oral agents as well as the increasing use of current and emerging injectable drugs will drive the overall multiple sclerosis drug market...
SOMERSET, N.J. — Legend Biotech Co. (NASDAQ: LEGN), a global leader in cell therapy, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expansion of the CARVYKTI® label to include adult patients with relapsed and refractory multiple myeloma, who have...
SOMERSET, N.J. – Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of ciltacabtagene...
STOCKHOLM, Sweden — BioArctic AB’s partner Eisai announced today that Leqembi® (brand name in China: “乐意保”, generic name: lecanemab-irmb) has been approved in China as a treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. China is the third country to grant marketing approval,...
NEW YORK, NY — LEXEO Therapeutics Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate...
THE WOODLANDS, Texas – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney...
EMERYVILLE, Calif. – Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has launched Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), also known as JZP458. Rylaze, which was approved by the FDA on June 30, 2021, is a recombinant erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for...