New Drugs

  • Pilot trial of first in kind biologic shows RA treatment potential

    on February 23rd, 2017
    FROM ANNALS OF THE RHEUMATIC DISEASES The novel biologic mavrilimumab that targets the GM-CSF pathway has shown therapeutic potential in the treatment of rheumatoid arthritis in a proof-of-concept trial, particularly in patients who have failed to respond to biologics that target other pathways. Wri[...]
  • Antibody could replace conventional antiviral therapy in HIV

    on February 22nd, 2017
    AT CROI SEATTLE (FRONTLINE MEDICAL NEWS) – In a phase II trial, an antibody that targets domain 1 of the CD4 receptor maintained viral suppression among patients who had been taking combination antiretroviral therapy (cART). The study lasted up to 16 weeks, and no viral rebound was seen. In vitro [...]
  • Lanadelumab reduced hereditary angioedema attacks by 88%-100%

    on February 22nd, 2017
    FROM THE NEW ENGLAND JOURNAL OF MEDICINE Lanadelumab, a monoclonal antibody that inhibits kallikrein, reduced attacks of hereditary angioedema with C1 inhibitor deficiency by 88%-100% in a small, phase I trial. Hereditary angioedema with C1 inhibitor deficiency is a rare disorder characterized by un[...]
  • Osimertinib helps NSCLC that progresses despite EGFR-TKIs

    on February 21st, 2017
    FROM THE JOURNAL OF CLINICAL ONCOLOGY Osimertinib, an epidermal growth factor receptor tyrosine kinase inhibitor selective for both EGFR and T790M mutations that render cancers resistant to EGFR-TKIs, yielded a high overall response rate, “encouraging” progression-free survival, and a durable tr[...]
  • Hope on the horizon for novel antidepressants

    on February 21st, 2017
    EXPERT ANALYSIS FROM THE NPA PSYCHOPHARMACOLOGY UPDATE LAS VEGAS – There remains a great unmet need for more effective and rapidly acting treatments for major depressive disorder, and research is revealing that both new and existing drugs may help, according to one expert. One argument for additio[...]
  • Nivolumab shows promise for pretreated advanced HCC

    on February 3rd, 2017
    AT THE 2017 GASTROINTESTINAL CANCERS SYMPOSIUM SAN FRANCISCO (FRONTLINE MEDICAL NEWS) – Nivolumab was associated with durable responses in heavily pretreated patients with advanced hepatocellular carcinoma in the dose-escalation and dose-expansion phases of the CheckMate 040 study. Further, the sa[...]
  • FDA approves nivolumab for advanced urothelial carcinoma

    on February 2nd, 2017
    The Food and Drug Administration has granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuv[...]
  • Adjuvant GEMOX disappoints for localized biliary tract cancer

    on February 1st, 2017
    AT THE 2017 GASTROINTESTINAL CANCERS SYMPOSIUM SAN FRANCISCO (FRONTLINE MEDICAL NEWS) – Post-surgery adjuvant treatment with gemcitabine and oxaliplatin (GEMOX) was feasible, but failed to significantly improve relapse-free survival when compared with surveillance among patients with localized bil[...]
  • Latuda receives FDA approval for adolescent schizophrenia treatment

    on January 31st, 2017
    Lurasidone HCl, marketed as Latuda, has received approval from the Food and Drug Administration for the treatment of schizophrenia in adolescents aged 13-17 years old, according to a press release from Sunovion Pharmaceuticals. FDA approval of Latuda is based on results of a 6-week study in which ad[...]
  • Refractory RA patients respond well to peficitinib in phase II study

    on January 31st, 2017
    FROM ARTHRITIS & RHEUMATOLOGY A 12-week course of daily oral peficitinib improved the severity of refractory rheumatoid arthritis in a manufacturer-sponsored phase II trial of the investigational drug, which inhibits all of the intracellular signaling molecules in the Janus kinase family. The ra[...]
  • FDA opens abbreviated approval pathway for interchangeable biosimilars

    on January 26th, 2017
    The Food and Drug Administration has proposed a regulatory path for biosimilar biologics that are interchangeable with the reference product, paving the way for a new generation of less-expensive versions of these unique drugs. But bringing an interchangeable biosimilar to market won’t be easy. Th[...]
  • Everolimus fails in pretreated gastric cancer

    on January 26th, 2017
    AT THE 2017 GASTROINTESTINAL CANCERS SYMPOSIUM SAN FRANCISCO (FRONTLINE MEDICAL NEWS) – Adding everolimus to paclitaxel failed to significantly improve outcomes in pretreated patients with gastric or esophagogastric junction adenocarcinoma in a German randomized phase III study. Median overall sur[...]
  • Semaglutide compares well with sitagliptin

    on January 26th, 2017
    AT THE ADA ANNUAL SCIENTIFIC SESSIONS NEW ORLEANS (FRONTLINE MEDICAL NEWS) – Semaglutide, a GLP-1 agonist for type 2 diabetes that’s dosed weekly, was superior to daily sitagliptin in improving glycemic control and reducing body weight in people who are also on metformin and/or thiazolidinedione[...]
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