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Daily news and top headlines for drug research professionals

Merck Diabetes Drug Hits Endpoints in Japanese Study

September 17, 2014 10:44 am | News | Comments

Merck announced the presentation of the first data from the Phase 3 clinical development program for omarigliptin, Merck’s investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes. Read more...         

Glenmark's TRPA1 Antagonist Excels in Phase 2a

September 17, 2014 10:33 am | News | Comments

Glenmark Pharmaceuticals announced that its first-in-class Transient Receptor Potential Ankyrin 1 antagonist, GRC 17536, has shown positive data in a Phase 2a study conducted on 138 patients in Europe and India. Read more...       

Relmada in MOA Agreement With MSKCC

September 16, 2014 3:47 pm | News | Comments

Relmada Therapeutics Inc. announced that it has entered into an agreement with Memorial Sloan Kettering Cancer Center (MSKCC) in a series of animal studies for levorphanol, the active ingredient of LevoCap ER. Read more...         

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TapImmune Releases Interim Data on Phase 1 Cancer Trial

September 16, 2014 3:39 pm | News | Comments

TapImmune Inc. reported that analysis of the interim data from the first 13 patients in a Phase 1 clinical trial show that each of the patients treated have raised specific T-cell immune responses against a set of five naturally processed folate receptor alpha Class II antigenic epitopes. Read more...

Amarin Committed to Completing Cardiovascular Outcomes Study

September 16, 2014 3:34 pm | News | Comments

Amarin Corp. announced its continued commitment to completing the ongoing REDUCE-IT (Reduction of Cardiovascular Events with EPA-Intervention Trial) cardiovascular outcomes study. Read more...                 

Mylan to Begin Phase 3 Trials on Key Generics

September 16, 2014 3:28 pm | News | Comments

Mylan Inc. announced it is initiating Phase 3 clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus.  Read more...                   

Nektar Says FDA Clears Constipation Drug Movantik

September 16, 2014 2:41 pm | News | Comments

Nektar Therapeutics said Tuesday that U.S. regulators approved its drug Movantik, a once-per-day treatment for constipation caused by opioid painkillers. Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by cancer. Read more...

Lilly, AstraZeneca Team Up on Alzheimer's Drug

September 16, 2014 11:43 am | News | Comments

Eli Lilly and Co. plans to pay up to $500 million to fellow drugmaker AstraZeneca as part of a collaboration to develop and sell a potential Alzheimer's disease treatment that is in the early stages of clinical testing. Read more...      

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Bayer, Orion Initiate Phase 3 Prostate Cancer Trial

September 16, 2014 10:26 am | News | Comments

Bayer HealthCare and Orion Corp. have begun to enroll patients in a Phase 3 trial with ODM-201, an investigational novel oral androgen receptor (AR) inhibitor in clinical development for the treatment of patients with prostate cancer. Read more...

Novo Nordisk's Insulin Shows Long-Term Efficacy in Children, Adolescents

September 16, 2014 10:19 am | News | Comments

Novo Nordisk announced new data from the BEGIN YOUNG 1 trial investigating once-daily Tresiba (insulin degludec) versus insulin detemir, both in combination with bolus insulin aspart in a 52-week trial in children and adolescents with type 1 diabetes. Read more...

Northwest Bio's Cell Therapy Named 'Promising Innovative Medicine'

September 16, 2014 10:04 am | News | Comments

An innovative cell therapy for cancer has become the first designated "promising" as part of a scheme to get medicines to patients quicker. The medicine, named DCVax-L, has been developed by U.S.-based pharmaceutical company Northwest Biotherapeutics Inc. Read more...

NY Suing Actavis to Halt Alzheimer's Drug Swap

September 15, 2014 7:39 pm | by Michael Virtanen | News | Comments

New York's attorney general filed a federal lawsuit Monday seeking to stop a manufacturer from discontinuing its drug widely used to treat Alzheimer's patients, arguing the company is illegally driving patients to its newer patented drug to avoid losses. Read more...

Merck Osteoporosis Drug Meets Primary Endpoint in Phase 3

September 15, 2014 3:49 pm | News | Comments

Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. Read more...           

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FDA Accepts Shire's sNDA for Vyvanse

September 15, 2014 3:43 pm | News | Comments

Shire announced that the FDA has accepted for filing with priority review a supplemental New Drug Application for Vyvanse (lisdexamfetamine dimesylate) capsules as a treatment for adults with binge eating disorder (BED). Read more...     

FDA Committee Backs Approval of Natpara for Treatment of Hypoparathyroidism

September 15, 2014 3:37 pm | News | Comments

NPS Pharmaceuticals Inc. announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted that the available data support the approval of Natpara for the long-term treatment of hypoparathyroidism. Read more...      

Lilly Colorectal Cancer Drug Hits OS Endpoint

September 15, 2014 3:31 pm | News | Comments

Eli Lilly and Co. announced that the RAISE trial, a Phase 3 study of ramucirumab (Cyramza) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. Read more...     

Amgen Heart Study Shows Positive Ivabradine Results

September 15, 2014 3:18 pm | News | Comments

Amgen announced data from the Phase 3 SHIFT study evaluating ivabradine in patients with chronic heart failure (HF) were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Las Vegas. Read more...   

Avanir Drug for Alzheimer's Agitation Excels in Trial

September 15, 2014 3:07 pm | News | Comments

Shares of Avanir Pharmaceuticals soared Monday after the company reported positive clinical trial results for a drug that is designed to treat agitation in Alzheimer's disease patients. Read more...                

Akashi Acquires Global Rights to Novel DMD Treatment

September 15, 2014 11:16 am | News | Comments

Akashi Therapeutics Inc. announced that it has acquired global rights to GsMTx-4, a peptide developed to address calcium level imbalance in muscle, a critical issue in Duchenne muscular dystrophy contributing to loss of function and other associated pathologies. Read more...

Germany's Merck Discontinues Lung Cancer Drug Program

September 15, 2014 11:01 am | News | Comments

Merck Serono will discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC). Read more...   

Cardio3 BioSciences to Continue Phase 3 Heart Therapy Trial

September 15, 2014 10:53 am | News | Comments

Cardio3 BioSciences SA (C3BS) announced it has received the recommendation of the Data Safety and Monitoring Board (DSMB) to continue the CHART-1 clinical trial according to the original protocol. Read more...            

Gilead to License Generic Version of Sovaldi

September 15, 2014 8:41 am | by The Associated Press | News | Comments

Gilead Sciences has reached a deal with several generic drugmakers to produce cheaper versions of its popular, expensive hepatitis C drug Sovaldi for use in developing countries. Read more...                 

Phase 2a Begins for Genocea's Pneumococcus Vaccine

September 12, 2014 7:00 am | News | Comments

Genocea Biosciences, Inc. announced the initiation of a Phase 2a trial for GEN-004, the company’s universal vaccine candidate against pneumococcus. The trial is designed to evaluate the effect of dosing with GEN-004 on the frequency, magnitude and duration of colonization by pneumococcus in the nasopharynx of healthy adults.

Data Validate 3x/Week MS Injections

September 12, 2014 7:00 am | News | Comments

Teva Pharmaceutical Industries Ltd. announced new data from the open-label Phase IIIb GLatiramer Acetate low frequenCy safety and patIent ExpeRience (GLACIER) study, comparing the safety and tolerability of three-times-a-week COPAXONE (glatiramer acetate injection) 40 mg to daily COPAXONE 20 mg in patients with relapsing-remitting multiple sclerosis (RRMS). 

Biogen Shows Positive Effects in Year Two of RMS Drug Trial

September 12, 2014 7:00 am | News | Comments

Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of PLEGRIDY (peginterferon beta-1a) were maintained in people with relapsing forms of multiple sclerosis (RMS) beyond the first year of the study. 

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