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Neurotrophic Keratitis Drug Gets Orphan Drug Designation

July 23, 2014 11:26 am | News | Comments

Dompe, a leader in R&D for new therapeutic solutions for the treatment of rare diseases, announced that rhNGF (Recombinant Human Nerve Growth Factor) has been designated as an orphan drug by the American Food and Drug Administration. Read more...

Shire to Spend About $225M on Drug Collaboration

July 23, 2014 11:20 am | News | Comments

The drugmaker Shire plans to spend about $225 million in a joint effort with a privately held, U...

Genes Play a Role in Radiation Survival

July 23, 2014 11:16 am | News | Comments

A team of researchers from the University of Wisconsin have identified 46 genes in ...

Merck Strengthens Commitment to Chinese Market

July 23, 2014 11:01 am | News | Comments

Merck, a leading company for high-tech products in the pharmaceutical and chemical sectors,...

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Autoimmune Disorders, Cancer Share Apoptosis Inhibitors

July 23, 2014 10:53 am | News | Comments

Autoimmune disorders may share certain pathogenic mechanisms with cancer, according to a new report by George Washington University researcher Linda Kusner, Ph.D., published in PLOS ONE, showing that the very same inhibitors of apoptosis, or cell destruction, in tumors are also expressed in cells that produce autoimmune diseases. Read more...

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 its ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. Read more...               

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FDA Fast Tracks New Epilepticus Drug

July 22, 2014 2:26 pm | News | Comments

SAGE Therapeutics announced that the FDA has granted fast track designation to the SAGE-547 development program, which will facilitate the development and expedite the review of the drug candidate. Read more...          

HIV Pills Show More Promise to Prevent Infection

July 22, 2014 1:47 pm | News | Comments

There is more good news about HIV treatment pills used to prevent infection in people at high risk of getting the AIDS virus: Follow-up from a landmark study that proved the drug works now shows that it does not encourage risky sex and is effective even if people skip some doses. Read more...

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 study in Polycythemia vera in collaboration with AOP Orphan. PSI is setting up this 100-patient open-label, multicenter study at 45 sites across 13 countries globally. Read more...

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 for the treatment of cancer, announced that it has completed recruitment of 210 patients for its Phase 2 FAST clinical trial to evaluate the combination of IMAB362 and chemotherapy as first-line therapy in patients with gastroesophageal cancer. Read more...

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...

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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...

Metabolic Enzyme Stops Renal Cancer Progression

July 22, 2014 10:52 am | News | Comments

In an analysis of small molecules called metabolites used by the body to make fuel in normal and cancerous cells in human kidney tissue, a research team from the Perelman School of Medicine at the University of Pennsylvania identified an enzyme key to applying the brakes on tumor growth. Read more...

Genetic Mapping Triggers Hope for Schizophrenia

July 22, 2014 10:40 am | by Seth Borenstein, AP Science Writer | News | Comments

Scientists have linked more than 100 spots in our DNA to the risk of developing schizophrenia, casting light on the mystery of what makes the disease tick, providing the first hard genetic evidence to bolster a theory connecting the immune system to the disease. Read more...

NIH Grants Sorrento Funding for Development of Small Molecule Inhibitor

July 21, 2014 3:57 pm | News | Comments

Sorrento Therapeutics Inc. announced that it has received non-dilutive funding for the preclinical development of a small molecule inhibitor targeting the important oncogenic transcription factor Myc. 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...

Arena Grants Marketing, Supply Rights for Belviq in Israel

July 21, 2014 3:28 pm | News | Comments

Arena Pharmaceuticals GmbH has entered into an exclusive marketing and supply agreement for Belviq (lorcaserin HCl) with Teva Pharmaceutical Industries Ltd.'s local Israeli subsidiary, Abic Marketing Limited. Read more...         

Gold Nanoparticles Penetrate Cells, Show Promise for Drug Delivery

July 21, 2014 3:09 pm | Videos | Comments

A special class of tiny gold particles can easily slip through cell membranes, making them good candidates to deliver drugs directly to target cells. 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...

Researchers Aim to Help Doctors Attack Metastases

July 21, 2014 11:22 am | News | Comments

Researchers at the University of Arkansas have been awarded $1.5 million from the National Cancer Institute at the National Institutes of Health to develop new molecules and biopharmaceuticals that enhance a patient’s immune response against tumors. Read more...

Allergan to Cut 1,500 Employees in Restructuring

July 21, 2014 11:10 am | by Tom Murphy, AP Business Writer | News | Comments

Botox maker Allergan will cut about 13% of its workforce, or roughly 1,500 employees, as part of a push to become more efficient and productive, and in the takeover battle's latest twist, Valeant said Monday it has complained to regulators that Allergan has been making false statements about its business. Read more...

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...                

InterMune Gets Breakthrough Therapy Status for IPF Drug

July 18, 2014 3:24 pm | News | Comments

InterMune, Inc. announced that pirfenidone, an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IPF), has been granted Breakthrough Therapy Designation from the FDA. 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...   

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