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Diabetes Drug Spurs Weight Loss, But Not Without Side Effects

July 2, 2015 12:30 pm | by Stephanie Guzowski, Editor | News | Comments

The injectable drug liraglutide, marketed as Saxenda, can help overweight or obese patients lose a significant amount of weight — but a study in the New England Journal of Medicine reports that the drug also carries several side effects. Read more...

Oramed Enrolls First Patient in its Phase 2B Oral Insulin Study

July 1, 2015 8:36 am | News | Comments

This U.S. based study will be performed under the active Investigational New Drug application on...

Merck: Phase 3 Study of Single-Dose Emend Met Primary Endpoint

June 30, 2015 11:36 am | News | Comments

Merck, known as MSD outside the United States and Canada, today announced results from a Phase 3...

New Study Verifies Accuracy of Rapid Ebola Test

June 30, 2015 8:18 am | by Tulane University | News | Comments

The study results confirm that the test can be used in the field and deliver a high level of...

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Lilly, Immunocore: Immunotherapy-based Clinical Trial Collaboration in Melanoma

June 29, 2015 9:48 am | News | Comments

Eli Lilly and Company and Immunocore Limited today announced that they have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore's lead T cell receptor-based investigational therapeutic, IMCgp100, in combination with Lilly's galunisertib (LY2157299) and merestinib (LY2801653) for the treatment of melanoma. Read more...

Turning the Tables on Cancer

June 29, 2015 9:29 am | by Shari Roan, UCLA | News | Comments

A new class of immunotherapies is enlisting the body's own immune system to fight cancer. Read more...

Blood Test IDs Pancreatic Cancer in 250 of 250 Patients

June 29, 2015 9:18 am | by Cynthia Fox, Science Editor | Articles | Comments

A new blood test identified pancreatic cancer with 100 percent accuracy in 250 of 250 patients, said a recent report in Nature. The test found pancreatic exosomes in blood via the biomarker GPC1. It distinguished early-stage cancer from late-stage cancer—with zero false positives/negatives. It predicted survival. Read more...

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NIH Begins Clinical Trial of New Medication for Alcohol Use Disorder

June 25, 2015 12:02 pm | by NIH | News | Comments

A clinical trial investigating a potential treatment for alcohol use disorder (AUD) was announced by the National Institute of Alcohol Abuse and Alcoholism (NIAAA). The study will assess the safety and efficacy of gabapentin enacarbil (HORIZANT) in extended-release tablets for treating moderate to severe AUD. NIAAA is part of the National Institutes of Health. Read more...

NeuroRx: First Human Trial Results Targeting Bipolar Depression, Suicidality

June 25, 2015 11:52 am | News | Comments

NeuroRx, Inc., a clinical phase pharmaceutical company, reports first-in-man efficacy data for a newly-purposed class of drugs targeted towards rapidly reducing symptoms of depression and suicidality in patients with bipolar disorder and maintaining that effect over time. Read more..

AbbVie Announces New Phase3b Results for Liver Cirrhosis

June 24, 2015 12:58 pm | News | Comments

AbbVie, a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis. Read more...

‘High-Normal’ Blood Pressure in Young Adults Spells Risk of Heart Failure in Later Life

June 24, 2015 8:55 am | by Johns Hopkins University | News | Comments

Mild elevations in blood pressure considered to be in the upper range of normal during young adulthood can lead to subclinical heart damage by middle age — a condition that sets the stage for full-blown heart failure, according to findings of a federally funded study led by scientists at Johns Hopkins. Read more...

Idarucizumab Reverses Anticoagulant Effect of Dabigatran Within Minutes in Patient Study

June 22, 2015 5:02 pm | News | Comments

Results from an interim analysis of the Phase 3 RE-VERSE AD patient study demonstrate that 5 g of idarucizumab immediately reversed the anticoagulant effect of dabigatran (Pradaxa) in patients requiring urgent anticoagulant reversal. Read more...

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Phase 3 Data Show Panitumumab Improves OS in Metastatic Colorectal Cancer

June 19, 2015 11:57 am | News | Comments

Amgen today announced that a Phase 3 study evaluating Vectibix® (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. Read more...

Pancreatic Cancer Treatment Pipeline Dominated by Early-Stage Development

June 18, 2015 9:12 am | by Joshua Libberton, Analyst, GBI Research | Articles | Comments

58 percent of drugs in the pancreatic cancer treatment pipeline are in the Discovery or Preclinical stages, 17 percent are in Phase 1 and 21 percent are in Phase 2, leaving just 4 percent of products in Phase 3 of development. Read more...

ICON Launches Patient Portal to Enhance Education Around Informed Consent

June 18, 2015 8:59 am | News | Comments

ICON plc, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced the launch of the Firecrest Patient Portal. This portal enables patients to view clinical trial information and is specifically designed to enhance the patients understanding of treatment before consenting to participate at an investigator site.  Read more...

Genticel Receives FDA Clearance of IND Application to Conduct Phase 1 Clinical of GLT001

June 17, 2015 8:58 am | News | Comments

The trial will take place in the United States. Read more...

Richter, Allergan Announce FDA Extended Review Period for Cariprazine to September 2015

June 17, 2015 8:47 am | News | Comments

Cariprazine is being reviewed for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Read more...

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Behavior Matters: Redesigning the Clinical Trial

June 15, 2015 3:59 pm | by California Institute of Technology | News | Comments

When a new type of drug or therapy is discovered, double-blind randomized controlled trials (DBRCTs) are the gold standard for evaluating them. These trials, which have been used for years, were designed to determine the true efficacy of a treatment free from patient or doctor bias, but they do not factor in the effects that patient behaviors, such as diet and lifestyle choices, can have on the tested treatment. Read more...

Novartis Presents New Data from Large European Study of Tasigna

June 15, 2015 3:37 pm | News | Comments

The final results of this large study, conducted in 26 European countries, were presented at the 20th Congress of the European Hematology Association (EHA) in Vienna. Read more...

Drug Discovery Spotlight: FDA Recommendation for Praluent, Repatha; Identifying Past Viral Infections

June 12, 2015 11:29 am | by Stephanie Guzowski, Editor | News | Comments

Two new cholesterol-lowering drugs, in a class their own, were FDA recommended this week and now, await approval. And a reasonably priced, new blood test can reveal a lifetime’s worth of viral infections. Read more...

Statins Don’t Harm Memory After All, Suggests Million-Patient Study

June 12, 2015 10:09 am | by Cynthia Fox, Science Editor | Articles | Comments

Statins, popular cholesterol lowering drugs, do not appear to cause short-term memory loss after all, according to a large recent study in JAMA Internal Medicine. The study, which looked at some one million patients, indicated past memory-loss reports may have been hampered by detection bias, as both statin users and users of non-statin lipid lowering drugs (LLDs) reported some memory loss. Read more...

Cancer Patient Treated as ‘Lab Rat’ Speaks Out After Duke Lawsuit

June 12, 2015 8:37 am | by Seth Augenstein, Digital Reporter | News | Comments

A woman who was a patient in a series of clinical trials called one of the biggest cases of medical fraud in history has spoken out about the devastation it wrought on her life. Joyce Shoffner, one of eight plaintiffs on a lawsuit over the bogus research by former Duke University researcher Anil Potti, told TV affiliate WRAL she was, “nothing but a laboratory rat,” to justify research. Read more...

EULAR 2015: Pfizer to Present New Data on Xeljanz

June 11, 2015 9:04 am | News | Comments

Highlights include over six-years of safety and efficacy data from two long-term extension studies. Read more...

EULAR 2015: Roche Gains Breakthrough Designation for Systemic Sclerosis Drug

June 11, 2015 8:55 am | News | Comments

Roche also initiated a global Phase 3 study in SSc. Read more...

FDA Panel Recommends Approval of New Cholesterol-Lowering Drug

June 10, 2015 11:25 am | by Stephanie Guzowski, Editor | News | Comments

A Food and Drug Administration (FDA) advisory panel on Tuesday recommended approval of a new injectable drug, alirocumab (Praluent) from Sanofi SA and Regeneron Pharmaceuticals, to help prevent heart attacks by lowering cholesterol. The new drug may be more powerful and carry fewer side effects than statins. Read more...

Neurocrine Suspends Two Clinical Studies of CRF Antagonist

June 9, 2015 1:15 pm | News | Comments

Neurocrine Biosciences, Inc. announced today that it has suspended two planned clinical studies of the Company's CRF antagonist NBI-77860. Read more...

Braeburn Pharmaceuticals: Positive Results From Phase 3 Opioid Addiction Study

June 8, 2015 11:06 am | News | Comments

Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. Read more...

Massachusetts General Hospital Launches Phase 2 Trial of BCG Vaccine to Reverse Type 1 Diabetes

June 8, 2015 10:51 am | by Massachusetts General Hospital | News | Comments

A phase 2 clinical trial testing the ability of the generic vaccine bacillus Calmette-Guérin (BCG) to reverse advanced type 1 diabetes has received approval from the U.S. Food and Drug Administration (FDA). Read more...

Amgen Completes Enrollment in Large Cardiovascular Trial of Repatha

June 8, 2015 10:03 am | News | Comments

Approximately 27,500 patients are now fully enrolled in FOURIER trial designed to evaluate if Repatha in combination with statin therapy reduces the risk of cardiovascular events. Read more...

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