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Daily news and top headlines for drug research professionals

Sanofi Signs 15-Year Supply Agreement for Wearable Injectors with Unilife

October 6, 2014 9:47 am | News | Comments

Unilife Corporation, a developer and supplier of injectable drug delivery systems, announced the signing of a worldwide Master Services and Commercial Supply Agreement with Sanofi to be the sole provider of cartridge based wearable injectors for all of Sanofi's applicable large dose volume drugs, excluding insulins, for a minimum 15 years. Read more...

CEL-SCI Enrolls 16 New Patients in Phase 3 Cancer Trial

October 3, 2014 3:33 pm | News | Comments

CEL-SCI Corp. announced that during the month of September the company enrolled 16 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase 3 trial. Read more...             

Fasting Blood Biomarker a-HB Predicts Diabetes Risk

October 3, 2014 3:11 pm | News | Comments

Could a single serum biomarker predict risk for diabetes as accurately as a more complex, hours-long diagnostic procedure? According to researchers at Health Diagnostic Laboratory Inc. and the University of Utah, the answer is "yes." Read more...

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Neurocrine Initiates Clinical Trial for Tourette Syndrome Therapy

October 3, 2014 2:58 pm | News | Comments

Neurocrine Biosciences, Inc. announced that it has initiated a clinical trial of NBI-98854, a proprietary small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, in both children and adolescents with Tourette syndrome. Read more...      

Halozyme Gets Orphan Drug Designation for Pancreatic Cancer Drug

October 3, 2014 2:49 pm | News | Comments

Halozyme Therapeutics, Inc. announced that the FDA has granted Orphan Drug designation for PEGylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer. Read more...                             

Salix Pharma Scuttles Cosmo Technologies Merger

October 3, 2014 10:10 am | News | Comments

Salix Pharmaceuticals is scrapping its merger with the subsidiary of an Italian drugmaker after the U.S. created new limitations on the tax benefits of incorporating overseas. Read more...

EU OKs Eli Lilly's $5.4B Bid for Novartis Division

October 3, 2014 10:00 am | News | Comments

The European Union's antitrust authority says it has approved the $5.4 billion sale of Novartis' animal health division to U.S. pharmaceutical firm Eli Lilly. The 28-nation bloc's executive Commission said Friday the sale won't hinder competition because the merged firm will continue to face a number of strong competitors. Read more...

Intarcia Announces Positive Results for Type 2 Diabetes Therapy

October 2, 2014 3:33 pm | News | Comments

Intarcia Therapeutics announced successful top-line results from two of its four phase 3 clinical trials for ITCA 650 . The first trial, FREEDOM-1, was a placebo-controlled, double-blind phase 3 clinical trial that tested the efficacy and safety of ITCA 650 in patients with type 2 diabetes against placebo. Read more...

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Ariad's Lung Cancer Drug Receives FDA Breakthrough Therapy Designation

October 2, 2014 3:21 pm | News | Comments

Ariad Pharmaceuticals, Inc. announced that its investigational cancer medicine, AP26113, has received Breakthrough Therapy designation by the FDA for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib. Read more...

NKT Therapeutics’ Sickle Cell Disease Drug Receives FDA Fast Track

October 2, 2014 2:42 pm | News | Comments

NKT Therapeutics announced that FDA has granted Fast Track designation to NKTT120, the company’s lead therapeutic being developed for the treatment of sickle cell disease. Read more...

Lilly Discontinues Development of Lupus Drug

October 2, 2014 2:33 pm | News | Comments

Eli Lilly and Company announced it will discontinue development of tabalumab­ -- being studied for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus) -- due to insufficient efficacy in two pivotal Phase 3 trials. Read more...

Experimental Ebola Vaccine Processed in Maryland

October 2, 2014 2:22 pm | News | Comments

The National Institute of Allergy and Infectious Diseases said an experimental Ebola vaccine is being processed at a facility in Frederick. The Frederick News-Post reported that the vaccine is a joint project between the federal agency and GlaxoSmithKline. Read more...

Amgen Announces Positive Data for Cholesterol-Lowering Medication

October 2, 2014 2:12 pm | News | Comments

Amgen announced The Lancet published data from two Phase 3 studies, RUTHERFORD-2 and TESLA, that showed treatment with evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication, resulted in a statistically significant reduction in LDL-C compared to placebo in patients with different types of familial hypercholesterolemia (FH). Read more...

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Takeda Announces Phase 3 Data for UC, Crohn's Drug

October 2, 2014 10:29 am | News | Comments

Takeda announced that new data from GEMINI LTS, a Phase 3, ongoing, open-label extension study of Entyvio (vedolizumab) for the treatment of adults with moderately to severely active UC and CD will be presented as oral presentations during the 21st United European Gastroenterology Week in Vienna, Austria. Read more...

High-Cholesterol Drug Data Lifts Esperion

October 2, 2014 10:13 am | News | Comments

Shares of Esperion Therapeutics surged in aftermarket trading after the company reported positive clinical trial results for its experimental high-cholesterol drug ETC-1002. Read more...                   

Discovery Helps to Spot What Makes a Good Drug

October 2, 2014 10:03 am | News | Comments

A new test developed by researchers from The University of Manchester could revolutionize the discovery of new prescription drugs. The test will help determine which drugs are unlikely to work at an early stage, speeding up the time it takes to make safe and effective medicines available. Read more...

Drugmaker Submits Harder-to-Abuse Zohydro to FDA

October 2, 2014 9:33 am | by Matthew Perrone, AP Health Writer | News | Comments

The maker of the much-debated painkiller Zohydro is seeking approval of a harder-to-abuse version of the drug which, if approved, could replace the currently marketed version of the pill by next spring. Read more...          

Merck Completes Sale of Consumer Unit to Bayer

October 1, 2014 3:52 pm | News | Comments

Drugmaker Merck said that it completed the sale of its consumer care business, which makes products including Claritin allergy medication and Coppertone sun-care line, to German health care company Bayer for $14.2 billion. Read more...     

Portola Pharmaceuticals Announces Phase 3 ANNEXA-A Data

October 1, 2014 3:45 pm | News | Comments

Portola Pharmaceuticals announced that its first Phase 3 study of andexanet alfa, a potential universal Factor Xa inhibitor antidote and U.S. Food and Drug Administration-designated breakthrough therapy, met its primary and secondary endpoints with high statistical significance. Read more...

Ebola Treatment Makers Rise After First U.S. Case

October 1, 2014 3:29 pm | News | Comments

Shares of several drugmakers developing potential vaccines or treatments for the deadly Ebola virus rose in premarket trading, continuing a run that started after federal officials confirmed that the first case of the disease has been diagnosed in the United States. Read more... 

Daiichi Sankyo Submits Cravit sNDA in Japan

October 1, 2014 12:57 pm | News | Comments

Daiichi Sankyo Co. Ltd. announced that it and its domestic generic subsidiary, Daiichi Sankyo Espha Co. Ltd., have submitted a supplemental New Drug Application (sNDA) in Japan for the synthetic broad-spectrum oral antibacterial agent Cravit Tablets. Read more...

Immunovaccine Announces Plans for Phase 2 Clinical Trial of DPX-Survivac

October 1, 2014 11:14 am | News | Comments

Immunovaccine Inc. (“Immunovaccine” or “IMV”), a clinical stage vaccine and immunotherapy company, provided a clinical development program update for DPX-Survivac, the company’s lead cancer vaccine candidate. Read more...

Drug and Device Firms Paid $3.5B to Care Providers

October 1, 2014 10:34 am | by Ricardo Alonso-Zaldivar | News | Comments

From research grants to travel junkets, drug and medical device companies paid doctors and leading hospitals billions of dollars last year, the government disclosed in a new effort to spotlight potential ethical conflicts in medicine. Read more...

Targeted Treatment Could Halt Womb Cancer Growth

October 1, 2014 10:06 am | News | Comments

A drug which targets a key gene fault could halt an aggressive womb cancer and shrink tumours, according to research published in the British Journal of Cancer. Read more...

J&J Buying Alios for $1.75B

September 30, 2014 3:03 pm | News | Comments

Johnson & Johnson is buying the biopharmaceutical company Alios BioPharma Inc. for about $1.75 billion. Alios is a privately held company that focuses on developing therapies for viral diseases. Read more...         

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