New Drugs

  • Dexcom G6 gets FDA nod

    on March 28th, 2018
    The first integrated continuous glucose monitoring system suitable for patients as young as 2 years has received market clearance from the Food and Drug Administration. The Dexcom G6 is about 28% smaller than its predecessor, the G5, can be worn for up to 10 days – 43% longer than the G5 – and d[...]
  • Siponimod trial ‘first’ to show delayed disability in secondary progressive MS

    on March 22nd, 2018
    FROM THE LANCET Phase 3 data with siponimod, Novartis’ investigational treatment for multiple sclerosis, show a 21% reduction in the time to disease progression versus placebo in patients with the secondary progressive subtype of the disease. A significantly lower percentage of patients with secon[...]
  • FDA approves new option in Hodgkin lymphoma treatment

    on March 20th, 2018
    The Food and Drug Administration has approved brentuximab vedotin, in combination with chemotherapy, for previously untreated adults with stage III or IV classical Hodgkin lymphoma. The drug, which is marketed by Seattle Genetics as Adcetris, is already approved in classical Hodgkin lymphoma after r[...]
  • FDA approves subcutaneous immunoglobulin treatment for CIDP

    on March 20th, 2018
    The Food and Drug Administration has approved Hizentra as the first subcutaneously administered human immunoglobulin maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP), according to a statement from its manufacturer, CSL Behring. Immune globulin subcutaneous[...]
  • VIDEO: Fezolinetant drops testosterone levels in PCOS

    on March 19th, 2018
    REPORTING FROM ENDO 2018 CHICAGO (FRONTLINE MEDICAL NEWS) – Testosterone levels dropped by one third for women with polycystic ovary syndrome (PCOS) and hyperandrogenemia when they received a centrally acting medication currently in development. The proof-of-concept phase 2 trial, which saw no con[...]
  • Fruquintinib promising agent for advanced NSCLC

    on March 12th, 2018
    FROM JOURNAL OF CLINICAL ONCOLOGY Investigational agent fruquintinib holds promise as a third- or fourth-line treatment option for patients with advanced non–small-cell lung cancer (NSCLC), according to new findings published in the Journal of Clinical Oncology. The median progression free surviva[...]
  • Dr. Paul E. Marik proclaims end to corticosteroid monotherapy for sepsis

    on March 8th, 2018
    REPORTING FROM CCC47 SAN ANTONIO (FRONTLINE MEDICAL NEWS) – While critical care specialists await more data on a so-called sepsis cocktail with varying degrees of hope and skepticism, Paul E. Marik, MD, FCCP, has proclaimed the dawning of a new era. Dr. Marik became a celebrity in the critical car[...]
  • Hemophilia A treatment gains approval in Europe

    on March 8th, 2018
    The European Commission has approved emicizumab for routine prophylaxis of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to emicizum[...]
  • FDA approves tests to screen for tickborne parasite in blood supply

    on March 7th, 2018
    The Food and Drug Administration has approved two new tests to screen whole blood and plasma supplies for the tickborne parasite Babesia microti. The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) detects antibodies to B. microti in human plasma samples and the Imugen Babesia microti [...]
  • New treatment options emerge for intermediate, advanced HCC

    on March 7th, 2018
    REPORTING FROM THE 2018 GI CANCERS SYMPOSIUM SAN FRANCISCO (FRONTLINE MEDICAL NEWS) – Two new therapies that target vascular endothelial growth factor signaling are efficacious and may expand the treatment armamentarium for intermediate and advanced hepatocellular carcinoma, data from a pair of ra[...]
  • Arm-placement indication for CGM approved by FDA

    on February 28th, 2018
    The Food and Drug Administration has approved a new indication for the Guardian Sensor 3 continuous glucose monitor (CGM), allowing patients to position it on their arms, according to an announcement by Medtronic, the sensor’s manufacturer. Although previously only the abdomen had FDA approval as [...]
  • Phase 2 study tests low-dose maintenance therapy for ALL

    on February 27th, 2018
    FROM CLINICALTRIALS.GOV Researchers at MD Anderson Cancer Center in Houston are studying the safety and clinical effectiveness of low-dose inotuzumab ozogamicin in controlling acute lymphocytic leukemia (ALL). The phase 2 study ( NCT03441061 ), which was launched on Feb. 15, will include up to 40 ad[...]
  • Dual kinase inhibitor performs well in its first safety, efficacy study for atopic dermatitis

    on February 26th, 2018
    REPORTING FROM AAD 2018 SAN DIEGO (FRONTLINE MEDICAL NEWS) – A novel molecule that inhibits two major inflammatory pathways acquitted itself well in its first safety and efficacy clinical trial in patients with moderate to severe atopic dermatitis. After 29 days, 100% of those taking the highest d[...]
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