USFDA

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's supplemental Biologics License Application (sBLA) for the expanded use of Enbrel® (etanercept) to treat pediatric patients with chronic severe plaque psoriasis.

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In 2015, the FDA granted Breakthrough Therapy and Priority Review designations for this indication. XALKORI also is indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Visunex Medical Systems, Inc. announced the FDA clearance of the Visunex Medical Systems PanoCam Pro Wide-field Imaging System for the imaging of all newborn infants.PanoCam Pro is a wireless imaging system that fills an unmet need in the imaging of all newborn babies that may help detect external, anterior, and posterior segment vision disorders that may have long-term effects on the vision of millions of children around the world each year.

Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to peptide SOR-C13 for the treatment of ovarian cancer.

Genmab A/S announced that a supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of ofatumumab (Arzerra®) in combination with  fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational anti-CD19 monoclonal antibody, MEDI-551, for the treatment of patients with neuromyelitis optica (NMO) as well as neuromyelitis optica spectrum disorders (NMOSD). Developed by MedImmune, MEDI-551 is currently in Phase IIb clinical development for NMO.

Cepheid announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Carba-R, a qualitative in vitro diagnostic test for fast, accurate, and reproducible identification of 5 distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP.

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Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, to include data from KEYNOTE-010.

Roche announced that the US Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan® (rituximab)-containing regimen, or had their follicular lymphoma return after such treatment. Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin lymphoma (NHL) and accounts for approximately one in five cases of NHL.

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Odefsey is Gilead’s second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV.