Clinical research
EMD Serono, a unit of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) had approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS).
Novartis will pay $310 million upfront for the Boston-based inflammation company IFM Tre. IFM TRE is very much an early-stage company, with one compound, IFM-2427, in an early Phase I clinical trial, and two preclinical assets.
During a presentation at the American Association for Cancer Research meeting over the weekend, Astellas touted new overall survival data for Xospata.
The SAB, composed of international experts in the field of allergy immunotherapy, acknowledged the clinical benefits of gp-ASIT+™ and confirmed the interest of a follow-up study to enhance the future market positioning and differentiation of the compound.
Eisai Co., Ltd. announced that in the 8th meeting of the Data Safety Monitoring Board for the global Phase III clinical studies on the investigational oral BACE inhibitor elenbecestat in early Alzheimer’s disease, the DSMB reviewed safety data including the potential for decline in cognition, and recommended the continuation of the studies.
Auris Medical Announces Randomization of First Dose Cohort in AM-201 Phase 1b Proof-of-Concept Study
Auris Medical Holding Ltd. announced that the first cohort of subjects have been randomized in its Phase 1b proof-of-concept trial of AM-201, the Company’s investigational drug for the prevention of antipsychotic-induced weight gain and somnolence.
Gilead Sciences and Belgium-based Galapagos NV reported positive late-stage results from its FINCH 1 and FINCH 3 rheumatoid arthritis studies.
Proteon Therapeutics, based in Waltham, Mass., announced that its PATENCY-2 Phase III clinical trial of vonapanitase in chronic kidney disease (CKD) failed to meet its co-primary endpoints.
The South San Francisco cuts are not surprising, given that in December the company was forced to halt a Phase III study of Rova-T.
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
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