Samsung Bioepis Co. Ltd. announced the company’s expansion in mainland China through a licensing agreement with C-Bridge Capital. The transaction covers multiple biosimilar candidates from Samsung Bioepis, including third-wave biosimilar candidates SB11 and SB12 – which reference Lucentis (ranibizumab) and Soliris (eculizumab) – as well as the biosimilar candidate SB3 that references Herceptin (trastuzumab).
Roche announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq in combination with Abraxane and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.
The U.S. FDA issued a Complete Response Letter to Netherlands-based Pharming Group for the company’s supplemental Biologics License Application for Ruconest.
GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).
The FDA approved Merz Neurosciences’ supplemental Biologics License Application for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.
The FDA granted Genentech’s Tecentriq triple combination with Avastain, paclitaxel and carboplatin Priority Review for the first-line treatment of patients with metastatic NSCLC.
Shire plc announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review for lanadelumab (SHP643).
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
The U.S. regulatory agency approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma.
The FDA accepted for filing Seattle Genetics’ supplemental Biologics License Application for Adcetris in patients with cutaneous T-cell lymphoma.