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Daily news and top headlines for drug research professionals

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...        

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...

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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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99% of Alzheimer's Drug Trials Fail, Study Says

July 7, 2014 1:53 pm | News | Comments

Researchers have conducted the first-ever analysis of clinical trials for Alzheimer’s disease (AD), revealing an urgent need to increase the number of agents entering the AD drug development pipeline and progressing successfully towards new therapy treatments. Read more...

Chronic Pain Drug Pushes Through Phase 3

July 7, 2014 12:47 pm | News | Comments

Endo Pharmaceuticals Inc. and BioDelivery Sciences International Inc. announced positive top-line results from its pivotal Phase 3 efficacy study of BEMA buprenorphine in opioid-experienced patients. Read more...            

BioDelivery’s Pain Drug Better than Placebo, Stocks Soar

July 7, 2014 11:17 am | News | Comments

Shares of BioDelivery Sciences International - a Raleigh, North Carolina, company - surged Monday before markets opened and after the drug developer said its potential severe pain treatment fared better than a placebo, or fake drug, in another late-stage study. Read more...

Japan First to Approve Alectinib for ALK+ NSCLC

July 7, 2014 11:11 am | News | Comments

Roche announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved alectinib for the treatment of people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+). Read more...

BI Submits MAAs in Europe for COPD Combo Drug

July 2, 2014 3:34 pm | News | Comments

Boehringer Ingelheim announced the submission of Marketing Authorization Applications in 31 European countries for the once-daily fixed-dose combination of tiotropium + olodaterol Respimat as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease. Read more...

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OncoGenex Opens Enrollment for Lung Cancer Trial

July 2, 2014 8:30 am | News | Comments

OncoGenex announced initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. Read more...      

Agenus Glioblastoma Vaccine Extends Survival in Phase 2

July 2, 2014 8:30 am | News | Comments

Agenus announced Phase 2 study results showing that patients with newly diagnosed glioblastoma multiforme who received Prophage autologous cancer vaccine, added to the standard of care treatment, lived nearly twice as long as expected. Read more...

PTC Therapeutics Begins Phase 3 Trial of Drug for Severe Cystic Fibrosis

July 1, 2014 1:36 pm | News | Comments

PTC Therapeutics announced the initiation of a global confirmatory Phase 3 clinical trial of Translarna (ataluren), an investigational new drug, in patients with nonsense mutation cystic fibrosis (nmCF). Read more...         

Innovation Reins in Runaway Pharma Spending

July 1, 2014 1:21 pm | by Nancy Dreyfus, Contributing Science Writer | Articles | Comments

To combat the rising costs of bringing a new drug to market, pharmaceutical companies have taken a variety of innovative approaches, according to the U.K. Office of Health Economics, such as deciding earlier in the R&D process to discontinue drugs lacking strong market prospects and better controlling clinical costs. Read more...

CTI BioPharma Wraps Up Recruitment in Pivotal Trial of Myelofibrosis Drug

July 1, 2014 11:30 am | News | Comments

CTI BioPharma Corp. announced that it has completed recruitment in the PERSIST-1 pivotal Phase 3 clinical trial of pacritinib, a novel oral JAK2/FLT3 inhibitor that is being evaluated for the treatment of primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, without exclusion for low platelet counts. Read more...

Ipsen Applies for US, EU GEP-NET Drug Marketing Authorizations

July 1, 2014 11:22 am | News | Comments

Ipsen announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline Depot 120 mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Read more...

GlycoVaxyn Kicks Off Trial of UTI Vaccine

July 1, 2014 11:17 am | News | Comments

GlycoVaxyn AG, a leader in the development of innovative conjugate vaccines, announced the initiation of a Phase 1 clinical trial of a candidate vaccine to prevent infections caused by Extra-intestinal Pathogenic Escherichia coli (ExPEC), such as urinary tract infections (UTIs). Read more...

Amgen’s Leukemia Drug Gets FDA Breakthrough Designation

July 1, 2014 11:10 am | News | Comments

Amgen announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to investigational bispecific T cell engager antibody blinatumomab, for adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia, a rapidly progressing cancer of the blood and bone marrow. Read more...

Taiho Oncology Posts Positive Results in Colorectal Cancer Study

June 30, 2014 11:03 am | News | Comments

Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co. Ltd. (Japan), announced detailed findings from its global Phase 3 RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug. Read more...

Essentialis Doses First Patient in Prader-Willi Study

June 27, 2014 1:46 pm | News | Comments

Essentialis announced the dosing of the first patient in clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients. Read more...   

AbbVie Initiates New Veliparib Trial in Advanced Breast Cancer

June 26, 2014 2:01 pm | News | Comments

AbbVie announced the initiation of a Phase 3 clinical trial of its investigational compound, veliparib, when added to carboplatin and paclitaxel, two chemotherapeutic medicines, in patients with advanced breast cancer. Read more...      

FDA Committee Rejects Cancer Drug Accelerated Approval

June 26, 2014 10:37 am | News | Comments

AstraZeneca announced that the FDA Oncologic Drugs Advisory Committee voted 11 to 2 that current evidence does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer with germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy. Read more...

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