Washington DC – Eli Lilly’s Omvoh (mirikizumab) secured approval from the US Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis (UC) in adults after a past rejection earlier this year. In April, the agency rejected the biologic licence application (BLA) for Omvoh citing...
treatment News
BOSTON, Mass. — Elicio Therapeutics, Inc., a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced that the first patient has been dosed at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York, as part of the randomized Phase...
BOSTON, Mass. — Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the publication of promising preclinical data in Cancer Immunology Research, a journal of the American Association for Cancer Research (“AACR”). These preclinical data...
WALTHAM, Mass. – Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) today announced the addition of a new study arm in the ongoing global Phase 2 clinical program for ELX-02 for the treatment of cystic fibrosis (CF) in patients with at least one G542X allele. The Phase 2 clinical program now includes a...
PINE BROOK, N.J. and BASEL, Switzerland — Elusys Therapeutics and Lonza Sales AG entered into an agreement for the production of Anthim(TM), a therapeutic monoclonal antibody in late stage development for the treatment of anthrax infection. Under this agreement, Lonza will provide process development services and manufacturing capacity for this...
Elypta announces the enrollment of the first patient in the newly initiated AURORAX-0093A (AUR93A) study. AUR93A is intended to explore Elypta’s metabolism-based liquid biopsy platform for the prognosis of muscle-invasive bladder cancer (MIBC) before neoadjuvant chemotherapy. The first patient was enrolled at San Raffaele Hospital, Milan, Italy. AUR93A In AUR93A,...
HYOGO, Japan – JCR Pharmaceuticals Co., Ltd. (TSE 4552; Chairman and President: Shin Ashida; “JCR”) announced today that European Medicines Agency (EMA) has granted orphan drug designation to JR-171, an investigational drug for the treatment of mucoplysaccharidosis type I (MPS I, or Hurler, Hurler-Scheie and Scheie syndrome). JR-171 is a blood-brain-barrier...
CASTELVECCHIO PASCOLI, Italy — Kedrion announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its investigational treatment for Congenital Aceruloplasminemia (ACP), a rare genetic disorder of iron metabolism. Aceruloplasminemia is an autosomal recessive disorder caused by mutations in the CP gene, leading to a deficiency or...
ROCKLAND, Mass. — EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of two new post-hoc analyses of tertiary endpoints from the MAGNIFY-MS study, a Phase IV, prospective, open-label study evaluating the efficacy and safety of MAVENCLAD® (cladribine) tablets in...
LAS VEGAS — Muscular dystrophies encompass a range of muscle disorders resulting from genetic mutations. Over time, these conditions lead to muscle weakness, which hinders everyday activities. Muscular dystrophy takes various forms, each targeting specific muscle groups and manifesting at different ages with varying degrees of severity. It can either...