BioSpace News Archive

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.

Vicarious Surgical Inc., a next-generation robotics company seeking to improve the cost, efficiency, and outcomes of surgical procedures, hosted the first public demonstration of its Beta 2 surgical robotic platform on December 6, 2022, highlighting the latest evolution of its differentiated technology and showcasing recent cadaveric testing.

Elpiscience Biopharmaceuticals, Inc. announced that the Center of Drug Evaluation has cleared Elpiscience’s Investigational New Drug Application for ES014 to initiate a Phase 1 clinical study for patients with advanced solid tumors.

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.

IASO Biotherapeutics announced that the Investigational New Drug application for its in-house developed BCMA CAR-T CT103A has been approved by the U.S. Food and Drug Administration for use in U.S. clinical trials for relapsed/refractory multiple myeloma.

Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that the FDA has granted a new Biosimilar User Fee Amendment goal date of April 13, 2023, for Alvotech’s original Biologics License Application for AVT02 as biosimilar to Humira®.

Eli Lilly and Company (NYSE: LLY) and ProQR Therapeutics N.V. (Nasdaq: PRQR), today announced the expansion of their licensing and collaboration agreement focused on the discovery, development and commercialization of new genetic medicines.

Bavarian Nordic A/S (OMX: BAVA) announced today that the Company has completed the planned enrollment of subjects in the global, randomized, double-blind Phase 3 clinical trial of its investigational respiratory syncytial virus (RSV) vaccine candidate, MVA-BN ® RSV in adults ≥60 years of age.

Merck and Kelun-Biotech today announced that the companies have entered into an exclusive license and collaboration agreement to develop seven investigational preclinical antibody-drug conjugates (ADC) for the treatment of cancer.

Pluri Inc., a leading biotechnology Company, issued the following update to shareholders from CEO and President Yaky Yanay and announced that as planned the Company’s joint venture with Tnuva Group has successfully achieved proof of concept in its development of cultivated meat based on Pluri’s proprietary 3D cell-based technology platform.