BioSpace News Archive

BioArctic AB’s partner Eisai announced that they have initiated submission of data for Biologics License Application to the National Medical Products Administration of China for lecanemab, an investigational anti-amyloid beta protofibril antibody.

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Lunsumio® for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Galapagos NV announced changes in the Executive Committee effective 1 January 2023.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for valbenazine as a treatment for chorea associated with Huntington disease (HD).

Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. Food and Drug Administration (“FDA”) has accepted for substantive review the Company’s de novo classification request seeking clearance to expand the functionality of Owlet’s Dream Sock’s existing sleep monitoring capabilities to include opportunistic heart rate and oxygen notifications, through software as a medical device that Owlet calls “Health Notifications.”

Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that for the first time, a patient was dosed in the United States with its in-house manufactured product candidate UCART22, and completed the 28 day DLT period on December 14th, 2022, without complication.

Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal full year ended September 30, 2022.

CytomX Therapeutics, Inc. announced that it plans to outline its pipeline priorities for 2023 and provide a data update for the CX-2029 Phase 2 cohort expansion study, on Thursday, January 5, 2023, after the close of U.S. markets.

Applied Molecular Transport Inc. announced top-line Phase 2 results from the LOMBARD monotherapy trial for AMT-101 in biologic-naïve and experienced patients with moderate-to-severe ulcerative colitis.

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated submission of data for Biologics License Application to the National Medical Products Administration of China for lecanemab, an investigational anti-amyloid beta protofibril antibody.