FDA Approves Eylea for Diabetic Retinopathy
The U.S. FDA approved Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) Injection for all stages of diabetic retinopathy, which is the leading cause of vision loss in diabetic patients.
Celgene and Acceleron File BLA for Potential Blockbuster Blood Disease Treatment
Celgene and developmental partner Acceleron Pharma are eying a potential U.S. FDA approval of a blood-disease treatment.
FDA Advisory Panel Gives Mixed Review to Sanofi’s Dengue Vaccine
A mixed review from a U.S. FDA panel of experts could sink the chances of a green light for Sanofi’s dengue vaccine Dengvaxia.
Alder Submits BLA to U.S. FDA for Eptinezumab
Alder BioPharmaceuticals Inc. announced the submission of a Biologics License Application (BLA) to the U.S. FDA for eptinezumab for migraine prevention targeting the calcitonin gene-related peptide (CGRP).
FDA Approves Novo Nordisk Hemophilia A Treatment
Denmark-based Novo Nordisk snagged approval from the U.S. FDA for a new treatment for hemophilia A, though Esperoct will not be available in the United States until 2020.
Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China
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).
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy for initial treatment of metastatic non-squamous non-small cell lung cancer
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.
FDA Requests Another Trial for Pharming’s Ruconest Label Expansion
The U.S. FDA issued a Complete Response Letter to Netherlands-based Pharming Group for the company’s supplemental Biologics License Application for Ruconest.
GSK says U.S. FDA wants more information on pulmonary drug
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).
Merz Snags FDA Approval for Chronic Sialorrhea
The FDA approved Merz Neurosciences’ supplemental Biologics License Application for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.
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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!