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Daily news and top headlines for drug research professionals

NIH Begins Early Human Clinical Trial of New Ebola Vaccine

October 22, 2014 2:00 pm | News | Comments

Human testing of a second investigational Ebola vaccine candidate is under way at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. Read more...                

Oramed Gets Positive Data From Oral Insulin Trial

October 22, 2014 10:03 am | News | Comments

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, reported positive top-line clinical results from its Phase 2a clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes. Read more...

Neurocrine Announces Phase 3 Study for Inhibitor

October 21, 2014 2:40 pm | News | Comments

Neurocrine Biosciences Inc. announced that it has initiated a Phase 3 clinical trial (Kinect 3 Study) of its proprietary Vesicular Monoamine Transporter 2 compound, NBI-98854.  Read more...                    

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Lilly's Diabetes Treatment Receives NDA

October 21, 2014 2:19 pm | News | Comments

FDA has accepted the filing of a NDA for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes (T2D). Read more...       

RegeneRx Proceeds With Phase 3 Eye Drop Study

October 21, 2014 10:43 am | News | Comments

RegeneRx announced that it met with the FDA in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 preservative-free eye drops for the treatment of patients with neurotrophic keratopathy (NK), an orphan disease of the cornea. Read more...

Boehringer Ingelheim Initiates Phase 3 Cancer Study

October 21, 2014 10:34 am | News | Comments

Boehringer Ingelheim announced enrollment of the first patient in a new global Phase 3 study in patients with mCRC. Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Read more...

New Class of Drugs Shows Promise for Treating Chronic Diarrhea

October 21, 2014 10:23 am | News | Comments

A pilot study testing a new type of drug in patients with chronic diarrhea has shown promising effects on reducing their symptoms. Read more...                                    

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...

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AbbVie Announces Results for HS Treatment

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

AbbVie announced new results from PIONEER 2, a pivotal Phase 3 study, demonstrating the effect of Humira (adalimumab) in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules. Read more...

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 million people in the U.S. and 40 million worldwide, generating annual healthcare costs that exceed $200 billion in the U.S. and $600 billion globally. By 2050, AD is expected to strike more than 115 million patients per year, according to the Alzheimer’s Association. Read more...

Personalized Cellular Therapy Achieves Remission in Leukemia Patients

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

Ninety percent of children and adults with ALL who had relapsed multiple times or failed to respond to standard therapies went into remission after receiving an investigational personalized cellular therapy, CTL019, developed at the Perelman School of Medicine at the University of Pennsylvania. Read more...

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...

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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...

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...

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...

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...        

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