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New study holds promise for patients with LCA

A new study led by Dr. Robert Koenekoop at the Montreal Children's Hospital at the McGill University Health Centre holds promise for certain patients with Leber congenital amaurosis, an inherited retinal degenerative disease that causes significant vision loss from birth. The study, sponsored by Canadian company QLT Inc., is designed to treat patients with LCA due to genetic mutations in either retinal pigment epithelium protein 65 or lecithin:retinol acyltransferase.

27 May 2010

Restanza shows greater efficacy against species of Plasmodium that cause malaria

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced positive results from in vitro and in vivo studies assessing the efficacy of Restanza (cethromycin), its novel oral antibiotic, against the species of Plasmodium that cause malaria.

27 May 2010

EMEND indication helps women prevent CINV

More women fighting cancers such as breast, lung, colorectal and ovarian can now help prevent the nausea and vomiting associated with their treatment of moderately emetogenic (vomit-inducing) cancer chemotherapy. Although new treatment entities have been developed in the past 10 years for control of chemically-induced nausea and vomiting, CINV remains a significant problem in the context of current practice.

26 May 2010

athenahealth releases the fifth annual PayerView Rankings

athenahealth, Inc., a leading provider of internet-based business services to physician practices, and Physicians Practice, America's leading practice management journal for physicians, today released the fifth annual PayerView Rankings, which indicate that health insurers are paying physicians on average seven days faster and denying 12-18% fewer claims than revealed in last year.

26 May 2010

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

Turning in assignments, following instructions and focusing on learning something new are among the daily classroom challenges for children with Attention Deficit Hyperactivity Disorder (ADHD), according to the National Institute of Mental Health (NIMH). New data presented today show efficacy of CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) on ADHD symptoms in children with the condition who also may face other specific challenges.

26 May 2010

Lyophilized heparin demonstrates better ability to preserve cord blood stem cells than CPD: Study

Lyophilized heparin, a proprietary anticoagulant developed specifically for cord blood collection, demonstrated a better ability to preserve the number of viable cells over a longer period of time than a commonly-used anticoagulant, citrate phosphate dextrose, according to a study presented today at the International Society for Cellular Therapy Annual Meeting.

26 May 2010

RSV appears to be predominant among Kenyan children hospitalized with severe pneumonia: Study

Among infants and children hospitalized in Kenya with severe pneumonia, respiratory syncytial virus appears to be the predominant virus detected, according to a study in the May 26 issue of JAMA.

26 May 2010

Positive results from 3 year follow-up of BPH patients treated with NX-1207 in Study NX02-0016

Nymox Pharmaceutical Corporation is pleased to report positive new results from the 30-36 month follow-up study of patients treated with NX-1207 in Study NX02-0016. The initial study, completed in the U.S. in 2007, reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 90 days and 6 months post-treatment with NX-1207 2.5 mg.

26 May 2010

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder in adolescents aged 13 to 17 years.

26 May 2010

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Trigemina, Inc., a Mountain View based privately-held biopharmaceutical company, reports positive results from a time-based interim analysis of its Phase IIa clinical trial in Chronic Daily Headache. The trial is a collaborative effort between Trigemina and Dr. Egilius Spierings of MedVadis Research Corporation located outside of Boston. The study compares intranasal oxytocin with placebo in patients suffering from CDH.

26 May 2010

Visually-guided laser-balloon catheter stops abnormal electrical pulses in patients with irregular heartbeats

A new treatment known as a visually-guided laser-balloon catheter successfully interrupted abnormal electrical pulses in patients and pigs with intermittent, irregular heartbeats, in a study reported in Circulation: Arrhythmia and Electrophysiology, a journal of the American Heart Association.

26 May 2010

NEVO Sirolimus-eluting Coronary Stent demonstrates safety and efficacy outcomes at 12 months

At 12 months the NEVO™ Sirolimus-eluting Coronary Stent has continued to demonstrate excellent safety and efficacy outcomes compared to Taxus® Liberte® according to new data presented today from the NEVO™ RES-I clinical trial. These results were presented as a late breaking trial at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.

26 May 2010

Lumizyme receives FDA approval for patients with late-onset Pompe disease

The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder.

26 May 2010

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

MAQUET Cardiovascular commences enrollment in trial of FUSION and FUSION BIOLINE Vascular Grafts

MAQUET Cardiovascular LLC today announced enrollment of the first patient in FINEST (FUSION Vascular Graft, FUSION Vascular Graft with BIOLINE and EXXCEL SOFT ePTFE). This prospective, randomized, single-blind, three-arm, parallel group, multi-center study is evaluating the safety and efficacy of MAQUET's investigational FUSION Vascular Graft and FUSION BIOLINE Vascular Graft, compared with its commercially available EXXCEL Soft ePTFE Vascular Graft in peripheral artery bypass surgery.

25 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

Spectrum Pharmaceuticals, Inc., a commercial stage biotechnology company with a primary focus in hematology and oncology, today announced that clinical data on belinostat will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology, to be held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.

25 May 2010

DMC recommends ARIAD continue Phase 3 trial of oral ridaforolimus for metastatic sarcomas to final analysis

ARIAD Pharmaceuticals, Inc. today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the second interim efficacy analysis as specified in the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas continue to its final analysis, without modification to the study protocol.

25 May 2010

ImmunoGen to present clinical data on IMGN388 solid tumor compound at 2010 ASCO

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that there will be several clinical data presentations for compounds utilizing the Company's Targeted Antibody Payload (TAP) technology at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago on June 4-8, 2010.

25 May 2010

NovaBay Pharmaceuticals completes enrollment in Phase 2a trial of NVC-422 for treatment of impetigo

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, today announced the completion of enrollment in a Phase 2a proof-of-concept trial for the treatment of impetigo.

25 May 2010

Efficacy News and Research

New study holds promise for patients with LCA

Restanza shows greater efficacy against species of Plasmodium that cause malaria

EMEND indication helps women prevent CINV

athenahealth releases the fifth annual PayerView Rankings

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

Lyophilized heparin demonstrates better ability to preserve cord blood stem cells than CPD: Study

RSV appears to be predominant among Kenyan children hospitalized with severe pneumonia: Study

Positive results from 3 year follow-up of BPH patients treated with NX-1207 in Study NX02-0016

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Visually-guided laser-balloon catheter stops abnormal electrical pulses in patients with irregular heartbeats

NEVO Sirolimus-eluting Coronary Stent demonstrates safety and efficacy outcomes at 12 months

Lumizyme receives FDA approval for patients with late-onset Pompe disease

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

MAQUET Cardiovascular commences enrollment in trial of FUSION and FUSION BIOLINE Vascular Grafts

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

DMC recommends ARIAD continue Phase 3 trial of oral ridaforolimus for metastatic sarcomas to final analysis

ImmunoGen to present clinical data on IMGN388 solid tumor compound at 2010 ASCO

NovaBay Pharmaceuticals completes enrollment in Phase 2a trial of NVC-422 for treatment of impetigo

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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