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Daily news and top headlines for drug research professionals

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...

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...

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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...

Judge Enforces Generic Frova Settlement in Favor of Mylan

April 11, 2014 10:12 am | News | Comments

Mylan Inc. confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan, settling patent litigation in connection with Mylan's generic version of Frova. 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...

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... 

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Lung Fibrosis and Survival Improved in Preclinical Study of Genkyotex’s GKT137831

April 10, 2014 3:03 pm | News | Comments

Genkyotex, the leading developer of selective NOX enzyme inhibitors, announced the publication of data showing that GKT137831, a first in class NOX1 and 4 inhibitor, was able to reverse lung fibrosis associated with aging in a new model of idiopathic pulmonary fibrosis. 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...   

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...

Ampio, Paladin Labs Partner on Zertane Rights

April 10, 2014 10:55 am | News | Comments

Ampio Pharmaceuticals Inc. announced that its subsidiary Vyrix Pharmaceuticals has signed an agreement with Paladin Labs Inc. to provide exclusive rights to market, sell and distribute Zertane in Canada, the Republic of South Africa, Sub-Saharan Africa and Latin America. 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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AbbVie's New Advanced Parkinson's Treatment Available in Canada

April 10, 2014 10:38 am | News | Comments

AbbVie announced that a new treatment called Duodopa (levodopa/carbidopa intestinal gel) is now available to Canadians with advanced Parkinson's disease. 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...            

New Vaccine Hope for Viral Cause of Birth Defects

April 10, 2014 10:25 am | News | Comments

Experts in infection and immunity have made a path-finding discovery that could lead to the development of a vaccine for a health-ravaging virus that affects around 50% of adults in the UK. Read more...              

Have Millions Been Wasted on Flu Drug?

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

British scientists say there isn’t enough evidence to prove the antiviral drug Tamiflu reduces the spread of flu. New study findings question whether governments worldwide were justified in spending millions on the drug during the 2009 swine flu pandemic. 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...

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...        

Compound Holds Potential to Treat Drug-Resistant Leukemias

April 9, 2014 10:06 am | News | Comments

Research in mice and human cell lines has identified an experimental compound dubbed TTT-3002 as potentially one of the most potent drugs available to block genetic mutations in cancer cells blamed for some forms of treatment-resistant leukemia.  Read more...

Teva Launches Generic Fish Oil Drug

April 9, 2014 8:30 am | News | Comments

Teva Pharmaceutical Industries said Tuesday it is now selling a generic version of the heart medication Lovaza, which is used to treat high triglyceride levels. Lovaza is made from omega-3 fish oils. Read more...            

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