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Galmed Gets IND Clearance for Fatty Liver Treatment

July 22, 2014 2:47 pm | News | Comments

Galmed Pharmaceuticals Ltd. announced that FDA cleared Galmed's Investigational New Drug application, permitting the company to conduct clinical trials of aramchol in the United States for the treatment of fatty liver disorders. Read more...   

Halozyme Resumes Pancreatic Cancer Trial

July 22, 2014 2:37 pm | News | Comments

Halozyme Therapeutics Inc. announced that it has resumed enrollment and dosing of patients in...

PSI, AOP Orphan Collaborate on Global Rare Disease Trial

July 22, 2014 11:56 am | News | Comments

PSI CRO, a full-service contract research organization, announced the launch of a new global...

Ganymed Completes Recruitment for Gastroesophageal Cancer Drug Trial

July 22, 2014 11:33 am | News | Comments

Ganymed Pharmaceuticals AG, a biopharmaceutical company developing Ideal Monoclonal Antibodies...

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FDA Grants Avastin Priority Review for Ovarian Cancer

July 22, 2014 11:05 am | News | Comments

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. Read more...

MedImmune, Advaxis Partner on Immuno-Oncology Combo Trial

July 22, 2014 10:59 am | News | Comments

AstraZeneca announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis Inc., a US-based biotechnology company developing cancer immunotherapies, providing further evidence of MedImmune’s commitment to explore novel combination approaches. Read more...

FDA Accepts Avanir's Trial App for Depression Drug

July 21, 2014 3:43 pm | News | Comments

Avanir Pharmaceuticals Inc. announced that the FDA accepted the company's Investigational New Drug (IND) application for a Phase 2 study assessing the safety and efficacy of AVP-786, Avanir's next generation compound. Read more...      

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Dipexium Launches Phase 3 Trial of Foot Ulcer Antibiotic

July 21, 2014 3:37 pm | News | Comments

Dipexium Pharmaceuticals Inc. announced it has initiated patient enrollment in the second of two pivotal Phase 3 clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex for the treatment of patients with mild infections of diabetic foot ulcers. Read more...

MetaMax Enrolls First Patients in Trial of Anticancer Drug

July 21, 2014 11:58 am | News | Comments

The first patients have been enrolled in a Phase 1/2a clinical trial of a promising approach to treat malignant neoplasms. Following approval by the Russian Ministry of Health, Russian biotechnology company MetaMax will begin the trial of its lead anticancer compound MM-D37K. Read more...

First Patients Enrolled in Trial of Opioid Dependence Treatment

July 21, 2014 11:49 am | News | Comments

Braeburn Pharmaceuticals announced that the first patients have been enrolled in its Phase 3 clinical study of Probuphine, a subdermal implant for the maintenance treatment of opioid dependence, for which there is an acute need for innovative and effective treatment options. Read more...

Combo Therapy Cures Hep C in Co-Infected HIV Patients

July 21, 2014 11:37 am | News | Comments

A multicenter team of researchers report that in a Phase 3 clinical trial, a combination drug therapy — sofosbuvir and ribavirin — cures chronic hepatitis C in the majority of patients co-infected with both HIV and hepatitis C. Read more...

China’s FDA Approves Conduct of Breast Cancer Trial

July 21, 2014 11:31 am | News | Comments

CASI Pharmaceuticals Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced that China's Food and Drug Administration has approved the company's application to conduct a Phase 2 clinical trial in triple-negative breast cancer patients in China for its proprietary drug candidate, ENMD-2076. Read more...

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JDRF, ViaCyte File IND App for Diabetes Treatment Trial

July 18, 2014 3:30 pm | News | Comments

JDRF announced that ViaCyte Inc. has filed an Investigational New Drug application (IND) with the FDA seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes. Read more...                

Amgen's Hyperparathyroidism Drug Hits All Endpoints in Phase 3

July 18, 2014 3:16 pm | News | Comments

Amgen announced that a Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. Read more...   

Bayer Eye Drug Shows Sustained Vision Improvement in DME

July 18, 2014 3:08 pm | News | Comments

Bayer HealthCare announced that in the Phase 3 VIVID-DME trial of aflibercept solution for injection into the eye for the treatment of vision impairment due to diabetic macular edema (DME), the solution showed a sustained improvement from baseline in best corrected visual acuity (BCVA). Read more...

Prana Updates Alzheimer's Development Program

July 18, 2014 11:38 am | News | Comments

Prana Biotechnology updated its clinical development program for Alzheimer's disease, noting that the starting amyloid burden level (baseline) in the PBT2 treated participant group had an important bearing on the decrease of amyloid over time in that participant (p=0.035), whereas there was no such correlation in the placebo group.. Read more...

NEJM Publishes Ipsen Data Showing Prolonged PFS from Somatuline

July 17, 2014 2:44 pm | News | Comments

Ipsen announced that the New England Journal of Medicine has published clinical trial results showing that Somatuline injection achieved statistically significant prolongation of progression free survival over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors. Read more...

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BMS, Pfizer Launch Phase 4 Eliquis Trial

July 17, 2014 1:54 pm | News | Comments

Bristol-Myers Squibb and Pfizer announced that the first patient has been enrolled into a Phase 4 clinical trial called EMANATE, assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion. Read more...

Arthritis Drug Shown to Slow Alzheimer’s

July 17, 2014 1:45 pm | News | Comments

A drug that is commonly used for arthritis has been shown to slow the progression of Alzheimer’s. A small randomized control study tested the drug Etanercept on patients with mild to moderate Alzheimer’s. Read more...          

Biotie Selects CDR System for Parkinson's Trial

July 17, 2014 11:11 am | News | Comments

Bracket is pleased to announce that Biotie Therapies, a specialized drug development company focusing on products for neurodegenerative and psychiatric disorders, has selected the CDR System for use as the primary endpoint for their Phase 2 trial of SYN120, an orally administered, dual 5HT6/5HT2a antagonist. Read more...

Studies Reveal New Niacin Risks

July 17, 2014 10:54 am | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

New details from two studies reveal more side effects from niacin, a drug that hundreds of thousands of Americans take for cholesterol problems and general heart health. Some prominent doctors say the drug now seems too risky for routine use. Read more...

Reoviruses: The Discovery of Their Potential in Cancer Therapeutics

July 17, 2014 10:23 am | by Brad Thompson, Ph.D., President and Chief Executive Officer of Oncolytics Biotech | Articles | Comments

Reoviruses - first isolated in 1951 - are benign viruses with an important property: they are oncolytic, meaning they are capable of infecting and destroying many kinds of cancer cells. The story of how this discovery was made is an exciting one. Read more...

Genentech Alzheimer's Drug Misses Goals in Studies

July 16, 2014 12:27 pm | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

An experimental drug from the biotech company Genentech failed to slow mental decline in mid-stage studies on more than 500 people with mild to moderate Alzheimer's disease, but showed some promise in the least-impaired participants who received a higher dose. Read more...

Pfizer Posts Positive Phase 3 Results for Hemophilia Drug

July 16, 2014 11:03 am | News | Comments

Pfizer Inc. announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFix Coagulation Factor IX (Recombinant) 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. Read more...

Pradaxa Available in the UK for DVT, PE

July 15, 2014 11:23 am | News | Comments

Boehringer Ingelheim has announced that Pradaxa will be commercially available in the UK for the treatment of DVT and PE - dangerous conditions with over 25,000 deaths estimated to occur in hospitalized patients each year in the UK - and the prevention of recurrent DVT and PE in adults, from Tuesday. Read more...

Oral Drug Improves Vision in Patients with Inherited Blindness

July 14, 2014 10:43 am | News | Comments

An international research project, led by the Research Institute of the McGill University Health Centre in Montreal, reported that a new oral medication is showing significant progress in restoring vision to patients with Leber congenital amaurosis (LCA). Read more...

Melanoma Drug Combo Meets Primary Endpoint

July 14, 2014 10:34 am | News | Comments

Roche announced that the Phase 3 coBRIM study met its primary endpoint when it demonstrated that cobimetinib, used in combination with Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening compared to Zelboraf alone. Read more...

Sanofi Dengue Shot Offers Some Protection

July 11, 2014 2:45 pm | by Maria Cheng, AP Medical Writer | News | Comments

The most advanced vaccine for dengue only offers modest protection but could still help millions of people avoid the devastating effects of the disease known as "breakbone fever," according to a large trial. Read more...         

Genticel HPV Vaccine Study on Track

July 11, 2014 11:19 am | News | Comments

Genticel, a French biotechnology company and leading developer of therapeutic vaccines, announce that the enrollment of the Phase 2 RHEIA-VAC study has reached the halfway mark of its recruitment target, and the study is on track with Genticel’s initial projections. Read more...

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