Efficacy News and Research

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AVI BioPharma, MDA to initiate exon-51 Phase 2 trial in Duchenne muscular dystrophy

More than a decade of targeted Muscular Dystrophy Association-funded research, made possible as a result of generous public support of the MDA Labor Day Telethon and thousands of grass-roots special events, has today culminated in MDA providing financial assistance for the start of the first Phase 2 placebo-controlled, multiple dose efficacy, safety, tolerability and pharmacokinetics clinical trial of an exon-51 skipping drug, eteplirsen, as a potential therapy for Duchenne muscular dystrophy.

16 Aug 2011

Enrollment commences in Omthera's Epanova Phase III trial for hypertriglyceridemia

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been enrolled in its ESPRIT Phase III clinical trial of Epanova, in patients with hypertriglyceridemia (TG level greater than or equal to 200 and < 500 mg/dL) despite treatment with a statin.

16 Aug 2011

Enrollment commences in RegeneRx RGN-259 Phase 2 trial for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. has announced that the first patients have been enrolled and randomized to receive RGN-259 or placebo in its 72-patient, Phase 2 clinical trial in patients with dry eye syndrome.

16 Aug 2011

Starpharma starts bacterial vaginosis prevention study of VivaGel

Starpharma Holdings Limited today announced the commencement of its Phase 2 study of VivaGel for the prevention of bacterial vaginosis (BV), following receipt of ethics approval.

15 Aug 2011

Fibrate drugs may not prevent heart attacks in diabetes patients with elevated cholesterol

Type 2 diabetes patients, who face higher risk of cardiovascular disease, often take a combination of medications designed to lower their LDL or "bad" cholesterol and triglyceride levels while raising their HDL or "good" cholesterol because doctors long have thought that taken together, the drugs offer protection from heart attacks and improve survival.

12 Aug 2011

Pyrazinamide inhibits trans-translation in Mycobacterium tuberculosis

For nearly 60 years, Pyrazinamide (PZA) has been used in conjunction with other medications to treat tuberculosis (TB), but scientists did not fully understand how the drug killed TB bacteria. PZA plays a unique role in shortening the duration of current TB therapy to six months and is used frequently to treat multi-drug resistant TB.

12 Aug 2011

Study confirms ability of Tru-D device to decontaminate surfaces in patient rooms

In an original article coauthored by John M. Boyce, MD; Nancy L. Havill, MT; and Brent A. Moore, PhD, "Terminal Decontamination of Patient Rooms Using an Automated Mobile UV Light Unit", the research team from the Hospital of Saint Raphael and the Yale University School of Medicine ". . . demonstrated that an automated, portable UV light device significantly reduced aerobic colony counts on high-touch surfaces in patient rooms.

12 Aug 2011

CPAP withdrawal leads to return of obstructive sleep apnea

The benefits of continuous positive airway pressure machines (CPAP) for patients with obstructive sleep apnea (OSA) are quickly reversed when the therapy is withdrawn, according to Swiss research.

12 Aug 2011

FDA assigns PDUFA action date for review of Affymax peginesatide NDA

Affymax, Inc. today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012 for the review of the investigational agent peginesatide New Drug Application.

12 Aug 2011

Pacira second quarter total revenues increase to $3.6 million

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced financial results for the second quarter ended June 30, 2011, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL, and updated its 2011 financial guidance.

11 Aug 2011

Researchers identify unknown link between migration of WBCs to infected tissues, immune memory

Researchers from Dr. Woodland's lab at the Trudeau Institute have now identified a previously unknown link between the migration of white blood cells to infected tissues and the ability of these cells to survive and become long-lived memory cells after the infection has been cleared.

11 Aug 2011

Anticoagulation service improves quality of care for patients treated with warfarin

A pharmacist-directed anticoagulation service improves the coordination of care from the hospital to an outpatient clinic for patients treated with the anticoagulant drug warfarin, according to a Henry Ford Hospital study.

11 Aug 2011

FDA approves Gilead's Complera for treatment of HIV-1 infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.

11 Aug 2011

Aeras, OETC announce initiation of new TB vaccine Phase IIb trial in patients with HIV

Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC) announce today the start of a Phase IIb proof-of-concept efficacy trial of a new investigational tuberculosis (TB) vaccine that involves people living with the human immunodeficiency virus.

11 Aug 2011

BELLUS Health second quarter revenues increase to $719,000

BELLUS Health Inc. reported today its financial results for the second quarter ended June 30, 2011.

10 Aug 2011

FDA approves Abbott's RX Herculink Elite Renal Stent System for renal artery stenosis

Abbott today announced it has received U.S. Food and Drug Administration (FDA) approval for the RX Herculink Elite® Renal Stent System for the treatment of renal artery stenosis (narrowing of the main arteries supplying blood to the kidneys) in patients with uncontrolled hypertension (high blood pressure).

10 Aug 2011

Glenmark commences Revamilast Phase IIb trial in chronic inflammatory disorders

Glenmark Pharmaceuticals today announced that its Novel Chemical Entity "Revamilast" (GRC 4039) has initiated Phase IIb human dose range finding trials globally. Revamilast is an orally active, potent and selective inhibitor of phosphodiesterase 4 (PDE 4) that is currently being developed by Glenmark for the treatment of chronic inflammatory disorders such as Asthma, Rheumatoid Arthritis (RA) and other inflammatory diseases.

10 Aug 2011

Trastuzumab drug increases risk of heart problems in elderly breast cancer patients

The first study to investigate the effect of the breast cancer drug trastuzumab (Herceptin) on heart and vascular function in elderly patients has found that it increases the risk of heart problems, particularly in women with a history of heart disease, diabetes or both.

10 Aug 2011

Nottingham researchers to develop new early warning system for Alzheimer's

Researchers at The University of Nottingham have been awarded £670,000 to develop a new early warning system for Alzheimer's disease.

9 Aug 2011

GTx reports revenue of $1.6 million for second quarter 2011

GTx, Inc. today reported financial results for the second quarter of 2011. The net loss for the quarter ended June 30, 2011 was $10.7 million compared with a net loss of $12.9 million for the quarter ended June 30, 2010.

9 Aug 2011

Efficacy News and Research

AVI BioPharma, MDA to initiate exon-51 Phase 2 trial in Duchenne muscular dystrophy

Enrollment commences in Omthera's Epanova Phase III trial for hypertriglyceridemia

Enrollment commences in RegeneRx RGN-259 Phase 2 trial for dry eye syndrome

Starpharma starts bacterial vaginosis prevention study of VivaGel

Fibrate drugs may not prevent heart attacks in diabetes patients with elevated cholesterol

Pyrazinamide inhibits trans-translation in Mycobacterium tuberculosis

Study confirms ability of Tru-D device to decontaminate surfaces in patient rooms

CPAP withdrawal leads to return of obstructive sleep apnea

FDA assigns PDUFA action date for review of Affymax peginesatide NDA

Pacira second quarter total revenues increase to $3.6 million

Researchers identify unknown link between migration of WBCs to infected tissues, immune memory

Anticoagulation service improves quality of care for patients treated with warfarin

FDA approves Gilead's Complera for treatment of HIV-1 infection

Aeras, OETC announce initiation of new TB vaccine Phase IIb trial in patients with HIV

BELLUS Health second quarter revenues increase to $719,000

FDA approves Abbott's RX Herculink Elite Renal Stent System for renal artery stenosis

Glenmark commences Revamilast Phase IIb trial in chronic inflammatory disorders

Trastuzumab drug increases risk of heart problems in elderly breast cancer patients

Nottingham researchers to develop new early warning system for Alzheimer's

GTx reports revenue of $1.6 million for second quarter 2011

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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