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Drugs Approvals and Trials

FDA approves new antibacterial drug Avycaz

The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections ...

FDA approves closure system to permanently treat varicose veins

Device is first to use adhesive to cut off blood supply ...

The Ottawa Hospital leads first Canadian clinical trial of mesenchymal stem cell therapy for multiple sclerosis

The Multiple Sclerosis Society of Canada and the Multiple Sclerosis Scientific Research Foundation announced today a $4.2 million grant to support the first Canadian clinical trial of mesenchymal stem cell therapy for multiple sclerosis (MS), led by Dr. Mark S. Freedman of The Ottawa Hospital and the University of Ottawa. ... Full story

FDA approves first generic esomeprazole

The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. ... Full story

Mount Sinai Launches Artificial Pancreas Research Study

A newly launched clinical research study at the Icahn School of Medicine at Mount Sinai is examining whether an artificial pancreas (AP) can prevent too low blood sugar levels or hypoglycemia in patients with type 1 diabetes (T1D) as they sleep. ... Full story

Malaria vaccine tested at RCSI proves successful in first human trial

Two new malaria vaccines which have undergone a clinical trial in humans, carried out by researchers at RCSI (Royal College of Surgeons in Ireland) in Dublin, have been proven to be well tolerated and produce a strong immune response. The results of the clinical trial are published in the current issue of the journal PLOS ONE. The clinical trial was conducted by researchers at RCSI's Department of International Health & Tropical Medicine at the RCSI Clinical Research Centre in Beaumont Hospital, Dublin, in collaboration with the Jenner Institute at the University of Oxford. The project is funded by the European Vaccine Initiative (EVI) with the support of Irish Aid. ... Full story

National trial first to focus on long-term complications associated with chronic kidney disease, diabetes, hypertension

DALLAS – UT Southwestern Medical Center – in collaboration with Parkland Health & Hospital System, Texas Health Resources, VA North Texas Health Care System, and ProHealth Physicians, Inc. of Connecticut – will lead the first National Institutes of Health-funded, multicenter, clinical trial to address interventions for patients with multiple chronic conditions centered around kidney disease. ... Full story

Study of Generic Antiepilepsy Drugs Finds Minimal Differences

CINCINNATI—A comparison of two of the most disparate approved generic antiepileptic drugs found minimal differences when compared under rigorous testing procedures in people with epilepsy, according to research presented by a University of Cincinnati (UC) clinician-researcher. ... Full story

Penn Medicine Researchers Announce Latest Results of Investigational Cellular Therapy CTL019

Findings Include Response Rates Over 90 Percent in Pediatric Acute Lymphoblastic Leukemia, and First Results of Non-Hodgkin Lymphoma Trial ... Full story

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