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Daily news and top headlines for drug research professionals

Prosensa Completes Enrollment in Natural History Study of DMD

June 25, 2014 11:06 am | News | Comments

Prosensa Holding N.V. announced the successful completion of enrollment in its prospective Natural History Study designed to increase the understanding of Duchenne muscular dystrophy (DMD). Read more...               

BI Launches Nintedanib EAP for Idiopathic Pulmonary Fibrosis

June 25, 2014 10:42 am | News | Comments

Boehringer Ingelheim announced that the company has initiated an open-label, U.S. multi-center expanded access program for its investigational compound nintedanib, for people diagnosed with idiopathic pulmonary fibrosis. Read more...     

BMS Says Cancer Drug Hit Goal in Study

June 24, 2014 7:23 pm | News | Comments

Bristol-Myers said Tuesday that its skin cancer drug nivolumab worked in a late-stage clinical trial, leading the drugmaker to end the study early. Bristol-Myers said patients treated with nivolumab lived longer than patients who received only chemotherapy. Read more...

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CF Foundation Applauds Positive Results of Ivacaftor, Lumacaftor Combo

June 24, 2014 2:36 pm | News | Comments

The Cystic Fibrosis Foundation applauds the successful results - significant improvements in lung function and other key measures of the disease - of Phase 3 studies of ivacaftor (Kalydeco) in combination with lumacaftor (VX-809) for people with two copies of the F508del mutation of cystic fibrosis (CF). Read more...

FDA Lifts Partial Hold on BRI’s Study of Glioma Drug

June 24, 2014 11:29 am | News | Comments

The Burzynski Research Institute Inc. (BRI) announced that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted, and it may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. Read more...

UK Guidelines Unfairly Exclude Prisoners from Clinical Research

June 24, 2014 10:52 am | News | Comments

Prisoners are being unfairly excluded from taking part in potentially beneficial clinical research, on the grounds that it would be too difficult and expensive to do so, indicates a study published online in the Journal of Medical Ethics. Read more...

Regado’s Anticoagulation System Suppresses Thrombin

June 23, 2014 2:30 pm | News | Comments

Regado Biosciences Inc., a biopharmaceutical company focused on the discovery and development of actively controllable aptamer therapeutics for the acute care setting, announced the publication in the Journal of Thrombosis and Thrombolysis of data from a single escalating-dose Phase 1 clinical trial of the REG2 anticoagulation system. Read more...

Rhythm’s Obesity Drug Increases Energy Expenditure

June 23, 2014 2:25 pm | News | Comments

Rhythm announced the presentation of results from a clinical trial that evaluated the effect of RM-493, the company's novel melanocortin 4 receptor (MC4R) agonist, on resting energy expenditure in obese subjects, indicating that RM-493 increased resting energy expenditure significantly. Read more...

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NW Bio Refutes Latest False Headline and Attack

June 23, 2014 2:18 pm | News | Comments

Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, refuted Adam Feuerstein's latest false headline and attack on the company, and reaffirmed the company's recent interim data announcements from its Phase 1/2 clinical trial of DCVax-Direct for all inoperable solid tumors. Read more...

Inovio Kicks Off Study of Cervical Cancer Immunotherapy

June 23, 2014 2:13 pm | News | Comments

Inovio Pharmaceuticals Inc. announced it has initiated a Phase 1/2a clinical trial to evaluate safety, immunogenicity, clinical responses and disease-free survival of its DNA immunotherapy product, INO-3112, in treating human papillomavirus (HPV)-associated cervical cancer. Read more...

Pharnext's Neuromuscular Disorder Drug Designated Orphan Drug

June 23, 2014 11:45 am | News | Comments

Pharnext SAS announced that the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to PXT-3003 for the treatment of Charcot-Marie-Tooth disease type 1A (CMT 1A) in recognition of the value this novel oral therapeutic could bring to these patients. Read more...

Novo Nordisk Posts Positive Phase 3 Data for Obesity Trial

June 23, 2014 11:39 am | News | Comments

New data from the phase 3a SCALE Obesity and Prediabetes trial were presented at the International Congress of Endocrinology and the Endocrine Society’s meeting, showing that in addition to a greater body-weight loss, significantly fewer people with obesity and normal blood glucose at baseline progressed to prediabetes with liraglutide 3 mg treatment at 56 weeks, compared with placebo. Read more...

BI Kicks Off Pradaxa First Ablation Trial

June 23, 2014 11:31 am | News | Comments

Boehringer Ingelheim announced the initiation of a new international study of Pradaxa (dabigatran etexilate mesylate) that will evaluate uninterrupted treatment with Pradaxa, compared to warfarin, in patients with paroxysmal or persistent non-valvular atrial fibrillation (NVAF) who are scheduled to undergo a first ablation procedure. Read more...

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GlycoMimetics Kicks Off Clinical Trials of Leukemia Drug

June 19, 2014 6:58 pm | News | Comments

GlycoMimetics Inc. announced that the first healthy volunteer has been dosed in a Phase 1 clinical study designed to evaluate the safety, tolerability and pharmacokinetics of GMI-1271, a novel and proprietary E-selectin antagonist in the company's pipeline. Read more...

Naloxegol Improves Opioid-Induced Constipation

June 19, 2014 6:44 pm | News | Comments

AstraZeneca announced that The New England Journal of Medicine (NEJM) has published results of two pivotal Phase 3 studies - KODIAC-4 and KODIAC-5 of naloxegol, an investigational treatment for opioid-induced constipation (OIC). Read more...

Protalix Enrolls First Gaucher Patient in Phase 2 Trial

June 19, 2014 3:07 pm | News | Comments

Protalix BioTherapeutics Inc. announced that the first Gaucher patient has been enrolled in the company's Phase 2a clinical trial of oral glucocerebrosidase (PRX-112), the company's proprietary plant cell expressed form of an active glycosylated glucocerebrosidase enzyme. Read more...

Debiopharm Kicks Off Phase 1 Study of MRSA Antibiotic

June 19, 2014 2:55 pm | News | Comments

Debiopharm Group announced the launch of a Phase 1 dose-escalation study of Debio 1450, a highly potent anti-infective agent that is selectively active against a large number of Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus and vancomycin-intermediate S. aureus. Read more...

Aratana Kicks Off Real World Study of Canine Lymphoma Drug

June 19, 2014 11:47 am | News | Comments

Aratana Therapeutics Inc., a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals, announced that it is currently enrolling patients in two nationwide clinical trials to evaluate its monoclonal antibody for canine T-cell lymphoma, AT-005. Read more...

Pfizer Posts Positive Two-Year Results for RA Drug

June 19, 2014 11:32 am | News | Comments

Pfizer Inc. announced the publication of two-year results from the ORAL Start study - a 24-month Phase 3 study in patients with moderately to severely active rheumatoid arthritis who had not previously received methotrexate - in the The New England Journal of Medicine. Read more...

Asmacure Posts Promising Phase 1/2a Asthma Drug Results

June 18, 2014 5:53 pm | News | Comments

Asmacure, a clinical-stage biopharmaceutical company focused on the development of novel, proprietary compounds that target cholinergic receptors for the treatment of pulmonary diseases, announced top-line results from a combined Phase 1 and 2a trial evaluating its lead compound, ASM-024, in moderate asthma patients. Read more...

Roche Snags Approval for Leukemia mAb

June 18, 2014 5:42 pm | News | Comments

In a head-to-head comparison with standard therapy with MabThera, Gazyvaro in combination with chemotherapy reduces the risk of disease progression or death in CLL patients by more than half, prompting Swiss regulatory and supervisory authority (Swissmedic) to grant marketing authorization. Read more...

FDA Grants Mirati’s Mocetinostat Orphan Drug Designation

June 18, 2014 1:29 pm | News | Comments

Mirati Therapeutics Inc. announced that mocetinostat, the company's spectrum selective HDAC inhibitor, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration as a treatment for myelodysplastic syndrome (MDS). Read more...

Metformin Modulates Gut Microbiome, Improves Glycemic Control

June 18, 2014 1:17 pm | News | Comments

MicroBiome Therapeutics LLC reported that a recently published scientific study shows that the diabetes drug, metformin, alters the bacterial populations in the gut in favor of a bacterial species that exerts specific cellular and immunological effects, resulting in improved glycemic control. Read more...

Merck Stops Development of Endocyte Cancer Drug

June 18, 2014 1:09 pm | News | Comments

Biotech drug maker Endocyte said Tuesday it has regained rights to an experimental cancer drug from Merck & Co., after the treatment failed in a key study last month, and Merck decided to discontinue development of vintafolide. Read more...

Vaccine ‘Reprograms’ Pancreatic Cancers

June 18, 2014 12:47 pm | News | Comments

Researchers at the Johns Hopkins Kimmel Cancer Center have developed and tested a vaccine that triggered the growth of immune cell nodules within pancreatic tumors, essentially reprogramming these intractable cancers and potentially making them vulnerable to immune-based therapies. Read more...

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