Study Affirms Safety of Anti-Clotting Drug
January 17th 2015Preliminary results of an ongoing post-marketing study examining Janssen Pharmaceuticals' rivaroxaban (Xarelto) in patients with non-valvular atrial fibrillation (NVAF) indicate that the anti-clotting drug's safety in real-world settings is consistent with the findings of previous phase 3 clinical trials.
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Simulated Saline Solution Recalled After Erroneous Patient Infusion
January 15th 2015Although the FDA previously warned health care professionals not to inject Wallcur's Practi-0.9% sodium chloride intravenous solution, given that the non-sterile product was for medical training purposes only, it was mistakenly administered to patients and is now being recalled.
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AstraZeneca Antiplatelet Drug Prevents Cardiovascular Events After Heart Attack
January 14th 2015AstraZeneca announced today that a study evaluating ticagrelor (Brilinta) for the secondary prevention of atherothrombotic events in patients with a history of heart attacks has met its primary efficacy endpoint.
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Novartis Submits NDAs for Investigational COPD Drugs Following Promising Trials
January 12th 2015Novartis announced that it has submitted New Drug Applications to the FDA for QVA149 and NVA237, investigational drugs for the long-term maintenance treatment of chronic obstructive pulmonary disease, following positive results from phase 3 trials of the drugs.
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Pharmacy Blood Pressure Monitoring Kiosks Comparable to Ambulatory Assessment
January 11th 2015Results of a peer-reviewed clinical study support the use of pharmacy-based PharmaSmart kiosks in assessing hypertension, as the routine blood pressure testing on the kiosks was deemed comparable to daytime ambulatory blood pressure measurement.
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Actavis Resubmits Cariprazine Approval Application to FDA
January 8th 2015The FDA has acknowledged receipt of Actavis's resubmitted New Drug Application for its investigational atypical antipsychotic, cariprazine, which is indicated for the treatment of patients with schizophrenia and manic or mixed episodes associated with bipolar I disorder.
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FDA Approves New Treatment for Cystic Fibrosis with Genetic Mutation
January 6th 2015A supplemental new drug application for the use of Vertex Pharmaceuticals' ivacaftor in cystic fibrosis patients aged 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene has been approved by the FDA.
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Baxter Submits Application for FDA Approval of Von Willebrand Disease Treatment
December 29th 2014Baxter International Inc has submitted a biologics license application to the FDA for the approval of BAX111, the first highly purified recombinant von Willebrand factor in clinical development as a treatment for von Willebrand disease.
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