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Daily news and top headlines for drug research professionals

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...

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Allergan Agrees to Move Forward With Meeting

September 16, 2014 6:41 am | by The Associated Press | News | Comments

Allergan and Pershing Square are agreeing on at least one step toward settling a fight over the makeup of the Botox-maker's board. Allergan will hold special shareholders meeting, as Pershing Square and its partner, Valeant Pharmaceuticals, continue their push for control of the drugmaker. 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...           

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...      

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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...                

EMD Serono Announces 2014 GMSI Grant Winners

September 15, 2014 11:29 am | News | Comments

EMD Serono announced the recipients of the second annual Grant for Multiple Sclerosis Innovation at the 2014 Joint ACTRIMS-ECTRIMS Meeting of the Americas Committee for Treatment and Research in MS (ACTRIMS) and European Committee for Treatment and Research in MS (ECTRIMS). 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...

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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...                 

BioTime, Charity Partner for Trial of Vaccine for Lung Cancer

September 12, 2014 2:00 pm | News | Comments

BioTime, Inc. announced that its subsidiary Asterias Biotherapeutics, Inc. has reached an agreement with Cancer Research UK and Cancer Research Technology— the charity’s development and commercialization arm— to conduct a clinical trial of Asterias’ novel immunotherapy treatment AST-VAC2 in subjects with non-small cell lung cancer.

FDA Backs Injection for Obesity

September 12, 2014 2:00 pm | News | Comments

Federal health experts say Novo Nordisk's diabetes drug Victoza should be approved for a new use in treating obesity. The panel of Food and Drug Administration advisers voted 14-1 that the injectable drug's benefits outweigh its risks for patients who are obese or dangerously overweight.

Novartis, Penn Team for Cellular Therapeutics Center

September 12, 2014 2:00 pm | News | Comments

The Univ. of Pennsylvania has reached an important milestone in its alliance with Novartis as it unveiled plans for the construction of a first-of-its-kind Center for Advanced Cellular Therapeutics on the Penn Medicine campus in Philadelphia.

Scientists Can Reset Human Stem Cells

September 12, 2014 2:00 pm | News | Comments

Scientists have successfully reset human pluripotent stem cells to the earliest developmental state– equivalent to cells found in an embryo before it implants in the womb (seven to nine days old). These pristine stem cells may mark the true starting point for human development, but have until now been impossible to replicate in the lab.

Biogen's Phase 3 Tecfidera Trial Shows Positive 5-Year MS Data

September 11, 2014 2:57 pm | News | Comments

Biogen Idec announced that five-year results from the ENDORSE Phase 3 extension study show Tecfidera (dimethyl fumarate) provides strong and sustained efficacy in a broad range of people living with relapsing-remitting multiple sclerosis (RRMS). Read more...

FDA Approves New Indication for the Use of Xtandi

September 11, 2014 2:51 pm | News | Comments

Astellas Pharma and Medivation announced that FDA approved a new indication for the use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). Read more...           

Many Hospitals Use Too Many Antibiotics, Study Says

September 11, 2014 2:46 pm | by Mike Stobbe, AP Medical Writer | News | Comments

Doctors in many U.S. hospitals are unnecessarily prescribing multiple antibiotics for several days when just one would do the job, a new study suggests. Read more...                         

Two Anti-Ebola Vaccines in Historic Race

September 11, 2014 2:41 pm | by Cynthia Fox, Science Editor | Articles | Comments

One of the most rapidly fast-tracked vaccines in history— an anti-Ebola “ChAd3” vaccine— just started clinical trial in humans, and may be done as soon as November. But a second fast-tracked anti-Ebola vaccine— called an “rVSV” vaccine— is hot on its heels. Read more...

Sanofi Posts Promising Trial Results for MS Drug

September 11, 2014 11:02 am | News | Comments

Sanofi and its subsidiary Genzyme announced positive interim results from the second year of the extension study of Lemtrada (alemtuzumab) for multiple sclerosis. Read more...                      

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