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Daily news and top headlines for drug research professionals

Prana Updates Alzheimer's Development Program

July 18, 2014 11:38 am | News | Comments

Prana Biotechnology updated its clinical development program for Alzheimer's disease, noting that the starting amyloid burden level (baseline) in the PBT2 treated participant group had an important bearing on the decrease of amyloid over time in that participant (p=0.035), whereas there was no such correlation in the placebo group.. Read more...

NEJM Publishes Ipsen Data Showing Prolonged PFS from Somatuline

July 17, 2014 2:44 pm | News | Comments

Ipsen announced that the New England Journal of Medicine has published clinical trial results showing that Somatuline injection achieved statistically significant prolongation of progression free survival over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors. Read more...

BMS, Pfizer Launch Phase 4 Eliquis Trial

July 17, 2014 1:54 pm | News | Comments

Bristol-Myers Squibb and Pfizer announced that the first patient has been enrolled into a Phase 4 clinical trial called EMANATE, assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion. Read more...

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Arthritis Drug Shown to Slow Alzheimer’s

July 17, 2014 1:45 pm | News | Comments

A drug that is commonly used for arthritis has been shown to slow the progression of Alzheimer’s. A small randomized control study tested the drug Etanercept on patients with mild to moderate Alzheimer’s. Read more...          

Biotie Selects CDR System for Parkinson's Trial

July 17, 2014 11:11 am | News | Comments

Bracket is pleased to announce that Biotie Therapies, a specialized drug development company focusing on products for neurodegenerative and psychiatric disorders, has selected the CDR System for use as the primary endpoint for their Phase 2 trial of SYN120, an orally administered, dual 5HT6/5HT2a antagonist. Read more...

Studies Reveal New Niacin Risks

July 17, 2014 10:54 am | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

New details from two studies reveal more side effects from niacin, a drug that hundreds of thousands of Americans take for cholesterol problems and general heart health. Some prominent doctors say the drug now seems too risky for routine use. Read more...

Reoviruses: The Discovery of Their Potential in Cancer Therapeutics

July 17, 2014 10:23 am | by Brad Thompson, Ph.D., President and Chief Executive Officer of Oncolytics Biotech | Articles | Comments

Reoviruses - first isolated in 1951 - are benign viruses with an important property: they are oncolytic, meaning they are capable of infecting and destroying many kinds of cancer cells. The story of how this discovery was made is an exciting one. Read more...

Genentech Alzheimer's Drug Misses Goals in Studies

July 16, 2014 12:27 pm | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

An experimental drug from the biotech company Genentech failed to slow mental decline in mid-stage studies on more than 500 people with mild to moderate Alzheimer's disease, but showed some promise in the least-impaired participants who received a higher dose. Read more...

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Pfizer Posts Positive Phase 3 Results for Hemophilia Drug

July 16, 2014 11:03 am | News | Comments

Pfizer Inc. announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFix Coagulation Factor IX (Recombinant) 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. Read more...

Pradaxa Available in the UK for DVT, PE

July 15, 2014 11:23 am | News | Comments

Boehringer Ingelheim has announced that Pradaxa will be commercially available in the UK for the treatment of DVT and PE - dangerous conditions with over 25,000 deaths estimated to occur in hospitalized patients each year in the UK - and the prevention of recurrent DVT and PE in adults, from Tuesday. Read more...

Oral Drug Improves Vision in Patients with Inherited Blindness

July 14, 2014 10:43 am | News | Comments

An international research project, led by the Research Institute of the McGill University Health Centre in Montreal, reported that a new oral medication is showing significant progress in restoring vision to patients with Leber congenital amaurosis (LCA). Read more...

Melanoma Drug Combo Meets Primary Endpoint

July 14, 2014 10:34 am | News | Comments

Roche announced that the Phase 3 coBRIM study met its primary endpoint when it demonstrated that cobimetinib, used in combination with Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening compared to Zelboraf alone. Read more...

Sanofi Dengue Shot Offers Some Protection

July 11, 2014 2:45 pm | by Maria Cheng, AP Medical Writer | News | Comments

The most advanced vaccine for dengue only offers modest protection but could still help millions of people avoid the devastating effects of the disease known as "breakbone fever," according to a large trial. Read more...         

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Genticel HPV Vaccine Study on Track

July 11, 2014 11:19 am | News | Comments

Genticel, a French biotechnology company and leading developer of therapeutic vaccines, announce that the enrollment of the Phase 2 RHEIA-VAC study has reached the halfway mark of its recruitment target, and the study is on track with Genticel’s initial projections. Read more...

Review: Gaps Between Approval, Safety Assessment of ADHD Drugs

July 10, 2014 12:00 pm | News | Comments

Over the last 60 years, the FDA approved 20 medications for ADHD based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers report. Read more...        

JDRF, Lexicon Collaborate on Phase 2 Diabetes Trial

July 10, 2014 12:00 pm | News | Comments

Lexicon Pharmaceuticals announced that JDRF will provide funding to support a Phase 2, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of LX4211 in a younger population with T1D. Read more...   

NIH Launches Phase 1 Trial of Novel C. Diff Drug

July 10, 2014 12:00 pm | News | Comments

The National Institute of Allergy and Infectious Diseases has launched an early-stage clinical trial of CRS3123, an investigational oral antibiotic intended to treat Clostridium difficile (C. difficile) infection. Read more...     

Vaccine Achieves Simultaneous Protection Against Ricin, Anthrax

July 10, 2014 12:00 pm | News | Comments

Soligenix Inc. announced that the combination of RiVax and VeloThrax induces protective immunity to both ricin toxin and anthrax toxin exposure. Read more...                           

Ario Kicks Off Efficacy Trial of Chronic Idiopathic Cough Drug

July 9, 2014 3:14 pm | News | Comments

Ario Pharma Ltd, the biopharmaceutical company developing innovative new treatments for respiratory disease, announced that it has commenced a Phase 2a study of its oral TRPV1 antagonist, XEN-D0501, for the treatment and prevention of cough in patients with chronic idiopathic cough. Read more...

Dezima Extends Clinical Development of Dyslipidemia Drug

July 9, 2014 3:02 pm | News | Comments

Dezima Pharma, the biotechnology company developing innovative drugs in the field of dyslipidemia, announced the approval of a Phase 1 pilot study in subjects with isolated, elevated Lipoprotein(a) (Lp(a)), for which additional funding has been secured. Read more...

Arthritis Drug Misses New Indication Endpoint

July 9, 2014 2:51 pm | News | Comments

Shares of Celgene Corp. slipped in premarket trading Wednesday after the drugmaker said its psoriatic arthritis treatment Otezla missed the main goal of a late-stage study exploring an additional use in a painful spinal joint disorder called ankylosing spondylitis. Read more...

Governor Pushes for Trials of Marijuana Derivative

July 9, 2014 1:12 pm | by Christina A. Cassidy | News | Comments

Georgia's governor is pushing clinical trials for a marijuana-derived drug that proponents say could help treat severe seizure disorders among children. Read more...                         

Insys Updates Timing of NDA for Dronabinol Oral Solution

July 9, 2014 11:18 am | News | Comments

Insys Therapeutics Inc. announced the successful completion of a human abuse study for Dronabinol Oral Solution, its proprietary, orally administered liquid formulation of the synthetic cannabinoid dronabinol in development for the treatment of CINV and anorexia associated with weight loss in patients with AIDS. Read more...

BI Posts Positive Results for Leukemia Drug

July 9, 2014 11:12 am | News | Comments

Results from a Phase 2 study that compared volasertib plus low-dose cytarabine (LDAC), a form of chemotherapy, versus LDAC alone in older patients with untreated acute myeloid leukemia (AML) were published in the American Society of Hematology journal Blood. Read more...

FDA Accepts NDA for Sanofi's Basal Insulin

July 8, 2014 10:40 am | News | Comments

Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin, formerly abbreviated as "U300." Read more...

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