Leo Pharma A/S, of Ballerup, Denmark, has eyed a stronger company presence in Asia during the past year and took a giant step to achieving it by signing a worldwide exclusive licensing agreement with Oneness Biotech Co. Ltd., of Taipei, Taiwan, and Microbio Shanghai Co. Ltd. to develop and commercialize FB-825 for treating atopic dermatitis and allergic asthma.
Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules.
Castle Creek Biosciences Inc. CEO John Maslowski told BioWorld the firm’s $75 million financing will propel phase III research with FCX-007 in recessive dystrophic epidermolysis bullosa (RDEB), with top-line data due in the first quarter of 2021 – “a big inflection point” for the Exton, Pa.-based company, which plans a BLA filing for that year as well.
Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened.