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Daily news and top headlines for drug research professionals

CBR Starts Cerebral Palsy Stem Cell Study

April 15, 2014 12:45 pm | News | Comments

Cord Blood Registry (CBR) announced the launch of an FDA-regulated clinical trial being conducted at The University of Texas Health Science Center at Houston to investigate two forms of stem cell therapy in children diagnosed with cerebral palsy. Read more...

AbbVie’s Lung Cancer Drug Advances to Phase 3

April 15, 2014 12:20 pm | News | Comments

AbbVie announced the initiation of a global Phase 3 clinical trial evaluating the safety and efficacy of its investigational compound, veliparib, in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer. Read more...

FDA OKs Trials for Vivolux First-in-Class Cancer Drug

April 15, 2014 10:32 am | News | Comments

Vivolux AB announced that the FDA has granted clearance to proceed with VLX600 into clinical Phase 1/2 trials. The drug candidate kills sleeping cell populations in regions of solid tumors that are metabolically compromised due to poor vascularization. Read more...

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Lexicon’s Type 1 Diabetes Trial Gets Positive Results

April 14, 2014 1:53 pm | News | Comments

Lexicon Pharmaceuticals Inc. announced positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. Read more...

FDA Accepts BI, Lilly NDA for Type 2 Diabetes Combo Tablet

April 14, 2014 1:39 pm | News | Comments

Boehringer Ingelheim and Eli Lilly and Co. announced that the FDA accepted the filing of the New Drug Application (NDA) for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with type 2 diabetes. Read more...

BMS Files NDA for HIV Combo Treatment

April 14, 2014 12:59 pm | News | Comments

Bristol-Myers Squibb announced the submission of a new drug application (NDA) to the FDA for a fixed-dose combination of atazanavir sulfate and cobicistat that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Read more...

Ipsen's Dysport Helps Upper Limb Spasticity in Phase 3 Trial

April 14, 2014 11:04 am | News | Comments

Ipsen announced that a first set of results on Phase 3 clinical study of Dysport in the treatment of adults suffering from Upper Limb Spasticity was presented on Saturday at the World Congress for NeuroRehabilitation in Istanbul. Read more...   

Janssen Posts Final Data from Phase 2 COSMOS Study

April 14, 2014 10:44 am | News | Comments

Janssen announced new results from cohort 2 of the Phase 2 COSMOS study demonstrating that 93% of patients with the hepatitis C virus (HCV) and advanced liver fibrosis who were treated with simeprevir and Gilead's sofosbuvir achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Read more...

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Abbvie’s Ribavirin Promising for Hep C Patients with Liver Cirrhosis

April 14, 2014 10:13 am | News | Comments

AbbVie announced results from the Phase 3 TURQUOISE-II, which evaluated the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's regimen with ribavirin (RBV) in adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis. Read more...

Collaboration Advances Use of Antibody Drug Conjugates

April 11, 2014 1:23 pm | News | Comments

PolyTherics Ltd. announced an extension to its ThioBridge antibody drug conjugate (ADC) collaboration with MacroGenics Inc., a U.S. biotechnology company developing innovative medicines utilizing its next generation antibody technologies. Read more...

After Setback, Impax Resubmits Parkinson’s NDA

April 11, 2014 12:36 pm | News | Comments

Impax Pharmaceuticals, a division of Impax Laboratories Inc., announced today the resubmission of Impax's NDA for Rytary (IPX066) to the FDA. IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease. Read more...

AbbVie's Hep C Regimen Posts Promising Phase 3 Results

April 11, 2014 10:36 am | News | Comments

AbbVie announced that in two Phase 3 studies, adult, non-cirrhotic patients with chronic genotype 1 hepatitis C virus infection receiving the investigational regimen with ribavirin (RBV) for 12 weeks achieved sustained virologic response rates 12 weeks post-treatment of about 96%. Read more...

Sovaldi Continues to Excel in Trials with Hep C, Advanced Liver Disease

April 11, 2014 10:01 am | News | Comments

Gilead Sciences Inc. announced data from two Phase 2 studies and a compassionate access study in which a regimen containing once-daily Sovaldi was administered for the treatment of chronic hepatitis C virus infection in patients with advanced liver disease. Read more...

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Governor Backs Medical Marijuana Trials

April 11, 2014 9:41 am | by Kathleen Foody | News | Comments

Georgia Gov. Nathan Deal on Thursday announced two separate efforts to pursue clinical trials on a cannabis-based drug that has shown promise in helping children who suffer from seizure disorders. Read more...           

Affimed’s Lymphoma Drug Shows Favorable Safety Profile, Activity

April 10, 2014 3:15 pm | News | Comments

Affimed Therapeutics AG announced further results from its Phase 1 clinical trial of AFM13 (a bispecific T and Ab antibody) as monotherapy for the treatment of patients with advanced relapsing/refractory (R/R) Hodgkin lymphoma. Read more... 

BMS Study Shows Potential for New Hep C Treatment

April 10, 2014 2:57 pm | News | Comments

Bristol-Myers Squibb Co. announced Phase 3 results from a global study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir and asunaprevir among genotype 1b hepatitis C virus (HCV) infected patients. Read more...   

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...

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...      

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...

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