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The Lead

Chimerix Gets FDA OK to Test Drug for Ebola

October 17, 2014 1:34 pm | News | Comments

A North Carolina drugmaker plans to test its experimental antiviral drug in patients who have Ebola, after getting authorization from regulators at the Food and Drug Administration. Read more...

AbbVie Announces Results for HS Treatment

October 17, 2014 1:21 pm | News | Comments

AbbVie announced new results from PIONEER 2, a...

A Novel Approach to Alzheimer’s Disease

October 17, 2014 9:57 am | by Daniel L. Alkon, M.D.,Chief Scientific Officer, Neurotrope Inc. and Toyota Chair in Neurodegenerative Disease, Scientific Director and Professor, Blanchette Rockefeller Neurosciences Institute | Articles | Comments

Alzheimer's disease (AD) afflicts more than 5...

Personalized Cellular Therapy Achieves Remission in Leukemia Patients

October 16, 2014 12:36 pm | News | Comments

Ninety percent of children and adults with ALL...

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Reversing Idiopathic Pulmonary Fibrosis

October 15, 2014 10:14 am | by Cynthia Fox, Science Editor | News | Comments

Lethal fibrosis in lungs of idiopathic pulmonary fibrosis (IPF) mouse models can be reversed, say Yale University researchers. Read more...                                      

Medtronic Begins Study of First Predictive Low Glucose Management Technology

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

Medtronic Inc. announced that the first patients have been enrolled in an investigational device exemption (IDE) study of its breakthrough Predictive Low Glucose Management (PLGM) technology, marking a critical step toward development of an artificial pancreas in the U.S. market. Read more...

C3BS Enrolls Patients in Switzerland in its Phase 3 Clinical Trial Chart-1

October 14, 2014 10:39 am | News | Comments

C3BS, a leader in the discovery and development of regenerative, protective and reconstructive therapies, announced it has received authorization from Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase 3 trial for C-Cure in Switzerland. Read more...

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BMS, Pharmacyclics and Janssen Collaborate on Non-Hodgkin Lymphoma Drug

October 13, 2014 2:25 pm | News | Comments

Bristol-Myers Squibb Company, Pharmacyclics Inc., and Janssen Research & Development LLC announced they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica. Read more...

Phase 2 Study to Evaluate Hepatitis C Drug Combination

October 13, 2014 10:41 am | News | Comments

Medivir AB announced that its partner Janssen recently initiated patient enrolment in a phase 2 study called IMPACT. This study evaluates the efficacy, safety and pharmacokinetics of the NS3/4A protease inhibitor simeprevir administered once daily in combination with Gilead’s nucleotide inhibitor sofosbuvir and Bristol-Myers Squibb’s (BMS) NS5A replication complex inhibitor daclatasvir. Read more...

Unexpected Genetic Link to Autoimmune Disease

October 13, 2014 10:27 am | News | Comments

The mutations were familiar, but the patients’ conditions seemed baffling at first. A team lead by Rockefeller University researchers had linked variations in an immune gene to rare bacterial infections. Read more...

FDA Approves Drug for Chemo-Associated Nausea, Vomiting

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

Helsinn Group and Eisai Inc. announced that the FDA approved Akynzeo for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy Read more...                

BIT225 Trial Results Show Effective Cure of Hepatitis C

October 10, 2014 10:41 am | News | Comments

Australian drug development company Biotron Ltd. announced that all Hepatitis C virus (HCV) genotype 3 (G3) patients completing a key Phase 2 trial of its lead antiviral drug, BIT225, have undetectable levels of HCV 12 weeks after ceasing all treatment. Read more...

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Patient's Response, Resistance to Cancer Drug Traced to Mutations

October 9, 2014 2:25 pm | News | Comments

The DNA of a woman whose lethal thyroid cancer unexpectedly “melted away” for 18 months has revealed new mechanisms of cancer response and resistance to the drug everolimus. Read more...                      

DelMar Pharmaceuticals' Cancer Drug Shows Promise

October 9, 2014 10:49 am | News | Comments

DelMar Pharmaceuticals Inc., a clinical-stage oncology company, announced the presentation of promising new data supporting the activity of its lead drug compound, VAL-083, in the treatment of non-small cell lung cancer (NSCLC). Read more...

Amgen Says Version of Humira Meets Study Goal

October 9, 2014 10:42 am | by The Associated Press | News | Comments

Amgen said that its version of Humira, the best-selling drug in the world, worked as well as the original medication in a late-stage clinical trial. Read more...                             

Past Drug Failures Help Create War on Cancer's Next Successes

October 8, 2014 12:31 pm | News | Comments

The Pharmaceutical Research and Manufacturers of America (PhRMA) released a new report, "Researching Cancer Medicines: Setbacks and Stepping Stones,"  which highlights the number of investigational cancer medicines that did not succeed in clinical trials and how these so-called "failures" are a critical part of the drug development process. Read more...

FDA Grants Fast Track Designation to NurOwn for the Treatment of ALS

October 7, 2014 2:45 pm | News | Comments

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that the United States Food and Drug Administration (FDA) has designated NurOwn as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). Read more...

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Vivolux Cancer Drug Receives FDA Clearance for Clinical Study

October 7, 2014 2:21 pm | News | Comments

Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 to clinical phase 1/2 for treatment against relapsed and/or refractory multiple myeloma. Read more...        

Acacia Pharma Gets Positive Results for PONV Treatment

October 7, 2014 10:36 am | News | Comments

 Acacia Pharma announces positive Phase 3 results with APD421 for the management of post-operative nausea & vomiting (PONV). Read more...                                   

Researchers Develop Personalized Ovarian Cancer Vaccines

October 7, 2014 10:02 am | News | Comments

Researchers at the University of Connecticut have found a new way to identify protein mutations in cancer cells. The novel method is being used to develop personalized vaccines to treat patients with ovarian cancer. Read more...         

Icon Bioscience Reports Last Patient Out in Phase 3 Cataract Study

October 6, 2014 3:30 pm | News | Comments

Icon Bioscience Inc., a specialty biopharmaceutical company focused on utilizing its Verisome drug-delivery platform to develop unique intraocular eye-care therapeutics, announced that the last patient has completed treatment in its pivotal Phase 3 study of IBI-10090. Read more...

BMS to Study Opdivo in Combination with Novartis' Lung Cancer Drugs

October 6, 2014 2:42 pm | News | Comments

 Bristol-Myers Squibb Company announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) with three molecularly targeted oncology therapies (Zykadia (ceritinib), INC280 and EGF816) from Novartis. Read more...

Alcobra Gets Positive Results for Adult ADHD Drug

October 6, 2014 10:22 am | News | Comments

Alcobra Ltd., an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced topline results from a Phase 3 study of Metadoxine Extended Release (MDX) in adults with ADHD. 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...

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...                             

Record Number of Clinical Trials for Multiple Myeloma this Year

October 3, 2014 2:11 pm | News | Comments

The Multiple Myeloma Research Consortium (MMRC) announced that it has opened six new clinical trials in 2014, and is on track to open more multiple myeloma clinical trials during 2014 than any other year since the Consortium was founded in 2004. 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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