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The Lead

FDA Approves Malignant Hyperthermia Drug

July 23, 2014 2:57 pm | News | Comments

Eagle Pharmaceuticals Inc. announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. Read more...      

Inovio's HPV Immunotherapy Hits Primary Endpoint

July 23, 2014 2:35 pm | News | Comments

Inovio Pharmaceuticals Inc. announced successful results from Phase 2 trial of VGX-3100 in women...

Oral Cancer Drug May be Potential Alzheimer’s Therapy

July 23, 2014 2:26 pm | News | Comments

Scientists are now reporting new progress on a set of compounds, initially developed for cancer...

Survey Finds Sharp Increase in Teen HGH Use

July 23, 2014 1:31 pm | by David Crary, AP National Writer | News | Comments

Experimentation with human growth hormones by America's teens more than doubled in the past year...

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FDA Approves Gilead's Zydelig for Three Cancers

July 23, 2014 1:13 pm | News | Comments

The Food and Drug Administration on Wednesday approved a new cancer drug from Gilead Sciences Inc. to treat chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. Read more...            

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.S. firm to develop a potential treatment for the rare and life-threatening genetic disorder Hunter syndrom, said the British company Wednesday. Read more...

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Biosceptre Posts Positive Results for Basal Cell Carcinoma Drug

July 23, 2014 11:07 am | News | Comments

Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor, announced positive results from its Phase 1 trial to assess the safety and tolerability of BIL-010t, a topically administered, highly purified sheep antibody therapy, to treat Basal Cell Carcinoma. 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...               

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...

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Easing Drug-Induced Fatty Liver Disease in HIV Patients

July 22, 2014 1:40 pm | News | Comments

The only drug to receive FDA approval for reduction of the abdominal fat deposits that develop in some patients receiving antiviral therapy for HIV infection may also reduce the incidence of fatty liver disease. 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...

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...

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...         

Antipsychotic Drugs Linked to Decreased Brain Volume

July 21, 2014 3:18 pm | News | Comments

A new study has confirmed a link between antipsychotic medication and a slight, but measureable, decrease in brain volume in patients with schizophrenia. 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...

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...   

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...

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