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Daily news and top headlines for drug research professionals

Tocagen Reports Positive Trial Results for Brain Cancer Combo

April 10, 2014 2:50 pm | News | Comments

Tocagen Inc. announced updated interim clinical data from two ongoing investigational studies of Toca 511 in combination with Toca FC in 68 patients with recurrent high grade glioma. Read more...                

Merck’s Hep C Drug Moving to Phase 3

April 10, 2014 2:34 pm | News | Comments

Merck announced additional data from the C-WORTHy study, a Phase 2 trial evaluating a regimen combining MK-5172, an investigational hepatitis C virus NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor, among patients with chronic HCV Genotype 1 infection. Read more...

Gilead Posts Positive Results for All-Oral Sofosbuvir Regimens

April 10, 2014 10:47 am | News | Comments

Gilead Sciences Inc. announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection. Read more...

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Hemophilia Drug Maintains Low Bleeding Rates in Children

April 10, 2014 10:34 am | News | Comments

Biogen Idec and Sobi released positive top-line results of the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of Eloctate in children with severe hemophilia A. Read more...            

Erytech Expands Tumor Starvation Development Portfolio

April 9, 2014 1:59 pm | News | Comments

Erytech Pharma announced the addition of a new product development candidate, ERY-MET, to the company’s tumor starvation product pipeline. Read more...                             

Nektar Reports Positive Preclinical Data for Two Oncology Programs

April 9, 2014 1:48 pm | News | Comments

Nektar Therapeutics announced that positive preclinical data for NKTR-102 and NKTR-214 were presented at the 2014 Annual Meeting of the AACR in San Diego, Calif. Read more...                      

FDA Wants More Info on Forest’s COPD Drug

April 9, 2014 1:38 pm | News | Comments

Forest Laboratories Inc. and Almirall S.A. announced that they have recently received feedback from the FDA regarding the fixed dose combination of aclidinium and formoterol for treatment of COPD. Read more...            

Phase 2 Efatutazone Trial Shows Challenge of Matching Treatment to Population

April 9, 2014 1:29 pm | News | Comments

Researchers hope that new work on a Phase 2 trial of efatutazone with erlotinib in patients with refractory non-small cell lung cancer will allow them to make better future use of the drug or other drugs in its class. Read more...      

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FDA Stops Halozyme PEGPH20 Pancreatic Cancer Trial

April 9, 2014 1:05 pm | News | Comments

Halozyme Therapeutics Inc. announced that the FDA informed the company Tuesday that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer. Read more...

Immunotherapy Shows Early Promise Against Advanced Melanoma

April 9, 2014 10:45 am | News | Comments

A new type of immunotherapy that directs patients’ immune responses toward tumor cell killing, IMCgp100, was well tolerated and showed efficacy in some patients with advanced melanoma in a Phase 1 clinical trial. Read more...        

Pharmacyclics Files Imbruvica Supplemental NDA

April 8, 2014 12:45 pm | News | Comments

Pharmacyclics Inc. announced that it has submitted a sNDA to the FDA based on data from the Phase 3 RESONATE study, a head-to-head comparison of Imbruvica versus ofatumumab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Read more... 

Merck Serono Begins Phase 3 NSCLC Trial of Tecemotide

April 8, 2014 10:19 am | News | Comments

Merck Serono announced the initiation of the Phase 3 START2 study, designed to assess the efficacy and safety of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide in patients with advanced Stage III non-small cell lung cancer. Read more...

Alkermes' Schizophrenia Drug Hits Key Phase 3 Endpoints

April 8, 2014 10:05 am | News | Comments

Alkermes plc announced positive top-line results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Read more...                 

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New Drug May Benefit Head, Neck Cancer Patients

April 8, 2014 8:30 am | News | Comments

Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) may benefit from treatment with the investigational drug dacomitinib if their cancer has no defects in a cell signaling pathway called the PI3K pathway and no signs of excessive inflammation. Read more...

Ambit Initiates Phase 2 Trial of Quizartinib Combo in AML, MDS

April 7, 2014 2:14 pm | News | Comments

Ambit Biosciences announced the initiation of the Phase 2 cohort of a Phase 1/2 study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia patients, or FLT3-ITD positive AML patients in first relapse. Read more...

Antibody-Drug Conjugate Benefits Melanoma Patients in Phase 1

April 7, 2014 2:00 pm | News | Comments

The investigational drug DEDN6525A, which is a new member of a class of drugs called antibody-drug conjugates, was safe, tolerable, and showed hints of activity against three different forms of melanoma. Read more...          

New Lilly Drug Promising Against Metastatic Breast Cancer

April 7, 2014 1:48 pm | News | Comments

The new oral drug LY2835219, an inhibitor of cyclin-dependent kinases 4 and 6, showed early promise as monotherapy for patients with metastatic breast cancer, particularly for those with hormone receptor-positive disease. Read more...     

Pfizer's New Breast Cancer Drug Shows Promise

April 7, 2014 8:30 am | by Christopher S. Rugaber, AP Economics Writer | News | Comments

An experimental drug has shown encouraging results in treating advanced breast cancer in an early clinical trial, pharmaceutical giant Pfizer reported Sunday. The drug prevented breast cancer from worsening for 20.2 months in trial. Read more...

Amgen Melanoma Drug Trial Misses OS Endpoint

April 4, 2014 1:22 pm | News | Comments

Amgen announced results from the primary overall survival analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor. Read more...

Halozyme Halts Pancreatic Cancer Trial

April 4, 2014 10:36 am | News | Comments

Halozyme Therapeutics announced that as a result of a recommendation from an independent Data Monitoring Committee, the company is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial in patients with pancreatic cancer. Read more...

Glenmark's Chronic Inflammatory Disease Drug Enters Human Trials

April 3, 2014 1:00 pm | News | Comments

Glenmark Pharmaceuticals announced that its Novel Chemical Entity (NCE) GRC 27864, a potent, selective, and orally bioavailable inhibitor of Microsomal Prostaglandin E synthase-1 (mPGES-1), is entering Phase 1human trials. Read more...   

FDA Accepts Omeros IND App for TMA Treatment

April 3, 2014 12:45 pm | News | Comments

Omeros Corp. announced that its Investigational New Drug (IND) Application to evaluate OMS721 for the inhibition of complement mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). Read more...

BioDelivery Sciences Opens Phase 3 Trial of Diabetic Neuropathy Gel

April 3, 2014 12:37 pm | News | Comments

BioDelivery Sciences International Inc. announced the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy. Read more...       

Fertility Drugs Do Not Increase Breast Cancer Risk

April 3, 2014 12:26 pm | News | Comments

Women who took clomiphene citrate or gonadotropins as a part of fertility treatment did not experience an increased risk for breast cancer over 30 years of follow-up, compared with women who were not treated with these medications, according to a study. Read more...

Gilead Hep C Combo Hits Primary Endpoint in Japan

April 3, 2014 11:10 am | News | Comments

Gilead Sciences announced top-line results from a Phase 3 clinical trial in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection. Read more...

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