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Clinical trial to study benefits of statins in prevention of heart attacks and strokes

Charles H. Hennekens, M.D., Dr.P.H., the first Sir Richard Doll Professor and senior academic advisor to the dean in the Charles E. Schmidt College of Medicine at Florida Atlantic University, recently published a commentary in the American Journal of Medicine, about the benefits of statins in the prevention of heart attacks and strokes in subjects previously thought at too low a risk to be treated.

28 Aug 2013

HCV treatment with sofosbuvir and ribavirin results in sustained virologic response

Treatment of chronic hepatitis C virus genotype 1 infection with the interferon-free regimen of sofosbuvir and ribavirin resulted in a high sustained virologic response rate in a patient population with unfavorable treatment characteristics, according to a study in the August 28 issue of JAMA.

28 Aug 2013

Virttu Biologics treats first cohort of patients in SEPREHVIR Phase I/IIa study

Virttu Biologics Limited, a UK biotechnology company with expertise in the field of oncolytic viruses, has announced that it has treated the first cohort of patients in its Phase I/IIa clinical study of its oncolytic virus, SEPREHVIR (HSV1716) for the treatment of malignant pleural mesothelioma.

27 Aug 2013

Lipidor announces positive results from Phase I/IIa study of AKVANO/calcipotriol for psoriasis vulgaris

Today Lipidor announced positive results from a Phase I/IIa study investigating the efficacy and tolerability of its AKVANO/calcipotriol spray formulation for the treatment of psoriasis vulgaris, the most common form of psoriasis.

27 Aug 2013

Sanofi Pasteur reports clinical benefit of Fluzone High-Dose vaccine in preventing influenza

Sanofi Pasteur, the vaccines division of Sanofi, today announced topline results of a large-scale, multi-center efficacy trial in people 65 years of age and older showing a superior clinical benefit of Fluzone High-Dose (Influenza Virus Vaccine) relative to the standard dose of Fluzone vaccine in preventing influenza.

26 Aug 2013

Laureate Biopharma collaborates with Dyax to develop new treatment candidate for HAE

Laureate Biopharma is pleased to announce its successful collaboration with Dyax Corp. for process development and cGMP production of a new treatment candidate for hereditary angioedema.

26 Aug 2013

Navidea Biopharmaceuticals signs SPA agreements with FDA for NAV5001 Phase 3 program

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has reached agreement with the U.S. Food and Drug Administration for two special protocol assessments for the Company's pivotal Phase 3 program with NAV5001 as an aid in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor.

23 Aug 2013

Takeda announces publication of data from two vedolizumab Phase 3 studies for ulcerative colitis and Crohn’s disease

Takeda Pharmaceutical Company Limited today announced that results from two Phase 3 studies evaluating vedolizumab, an investigational humanized monoclonal antibody, for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, were published in the August 22, 2013 issue of the New England Journal of Medicine.

22 Aug 2013

Oramed starts patient recruitment in Israel for ORMD-0801 clinical trial for patients with T1DM

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it has initiated patient recruitment for a new clinical trial of its orally ingestible insulin capsule, ORMD-0801 for patients with type 1 diabetes mellitus in Israel.

22 Aug 2013

Oncopeptides launches phase II study to determine efficacy of melflufen in treatement of multiple myeloma

Oncopeptides AB, a company working to enhance oncology therapies, today announced that the first patient has been dosed as part of a Phase II study in multiple myeloma patients with its drug candidate melflufen (previously called J1).

21 Aug 2013

Twice-daily KALYDECO improves lung function in people with cystic fibrosis

Vertex Pharmaceuticals (Australia) Pty Ltd., announces the presentation of data from KALYDECO (ivacaftor) studies at the 10th Australasian Cystic Fibrosis Conference in Auckland, New Zealand, August 17 – 20, 2013, which further demonstrate the benefits of the medicine in people with cystic fibrosis ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator gene.

21 Aug 2013

ROX Medical crosses halfway point in CONTROL-HTN multi centre, randomized controlled hypertension trial

ROX Medical has crossed the halfway point in the CONTROL-HTN international, multi centre, randomized controlled hypertension trial. The milestone was met with the enrollment of the first patient from Prof. Markus van der Giet and Prof. Walter Zidek of the Charite Hospital, Benjamin Franklin Campus, Berlin.

20 Aug 2013

Clinical trial shows type-1 diabetes patients treated with teplizumab exhibit greater response to therapy

Primary results from a new clinical trial show that patients with type 1 diabetes treated with the monoclonal antibody teplizumab (MacroGenics, Inc.) exhibit greater preservation of C-peptide, a biomarker of islet cell function, compared to controls.

20 Aug 2013

Second GSK intramuscular quadrivalent influenza vaccine approved by the FDA

GlaxoSmithKline plc [LSE/NYSE: GSK] announced that the U.S. Food and Drug Administration (FDA) has approved FLULAVAL® QUADRIVALENT (Influenza Virus Vaccine) for the active immunization of persons three years of age and older to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B contained in the vaccine.

19 Aug 2013

FDA grants Orphan Drug Designation to ADXS-HPV for treatment of HPV-associated anal cancer

Advaxis, Inc., (OTCQB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated anal cancer.

17 Aug 2013

Study: Type 2 diabetic patients treated with DPP-4 linagliptin experience reductions in blood glucose levels

Data published in The Lancet showed that elderly people with Type 2 Diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, marketed by Boehringer Ingelheim and Eli Lilly and Company, experienced significant reductions in blood glucose levels (HbA1c) compared with those receiving placebo.

17 Aug 2013

Phase II trial to investigate vaccine therapy combined with Avastin for patients with recurrent GBM

Northwestern Medicine- recently joined a landmark clinical trial to investigate if a vaccine made from a patient's own brain tumor is effective in slowing tumor progression and extending survival.

16 Aug 2013

Boehringer Ingelheim completes patient enrolment of two pivotal Phase III interferon-free hepatitis C clinical trials

Boehringer Ingelheim today announced that enrolment of over 950 treatment naïve genotype-1b patients in the pivotal Phase III interferon-free HCVerso™ 1 and 2 trials is complete.

15 Aug 2013

Cedars-Sinai launches Phase I clinical trial to study tolerability of immunization to treat Alzheimer's disease

Cedars-Sinai Medical Center has launched a Phase I clinical trial to study the safety and tolerability of an experimental immunization to treat Alzheimer's disease. The treatment is based on Copaxone (glatiramer acetate), a drug often prescribed to reduce the frequency of multiple sclerosis relapses.

13 Aug 2013

Patients with IBS-D treated with eluxadoline achieve better clinical response

Patients with diarrhea-predominant irritable bowel syndrome, or IBS-D, treated with eluxadoline achieved better clinical response and experienced more symptom improvement than those using placebo, according to a recent study in Gastroenterology, the official journal of the American Gastroenterological Association. Eluxadoline, which is currently in phase 3 trials, is under development as a potential treatment for IBS-D.