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CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the U.S. Food and Drug Administration for treatment substitution in patients with Human Immunodeficiency Virus (HIV).

19 Feb 2014

Viamet announces positive interim results from VT-1161 Phase 2 study in patients with AVVC

Viamet Pharmaceuticals Inc. today reported positive interim results from an ongoing Phase 2 study of VT-1161, the Company's novel oral antifungal compound, in patients with moderate to severe acute vulvovaginal candidiasis (AVVC). This study is intended as a precursor to a Phase 2b study in patients with recurrent vulvovaginal candidiasis (RVVC).

18 Feb 2014

GENFIT receives FDA Fast Track designation for GFT505 development program in NASH

GENFIT, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces that the Food and Drug Administration has granted Fast Track designation to the GFT505 development program in NASH, with effect from February 14, 2014.

18 Feb 2014

New score ‘reliable and valid’ for neurogenic bladder dysfunction

The Neurogenic Bladder Symptom Score is both valid and reliable for assessing urinary dysfunction in people with acquired or congenital neurogenic bladder, according to a study published online in the Journal of Urology.

17 Feb 2014

Afatinib ‘first line’ for advanced mutation-positive lung cancer

Afatinib should be given as a first-line treatment for Asian patients with advanced, epidermal growth factor receptor mutation-positive, non-small-cell lung cancer, researchers recommend.

17 Feb 2014

Commonly-used HIV drug kills HPV that leads to cervical cancer

A commonly-used HIV drug has been shown to kill-off the human papilloma virus (HPV) that leads to cervical cancer in a world-first clinical trial led by The University of Manchester with Kenyatta National Hospital in Nairobi.

17 Feb 2014

Research findings may help combat MRSA

A research team from Vanderbilt University Medical Center in Nashville, Tenn., is the first to decipher the 3-D structure of a protein that confers antibiotic resistance from one of the most worrisome disease agents: a strain of bacteria called methicillin-resistant Staphylococcus aureus (MRSA), which can cause skin and other infections. The Vanderbilt team's findings may be an important step in combatting the MRSA public health threat over the next 5 to 10 years.

17 Feb 2014

Research findings have important implications for personalized treatment of alcohol abuse

Heavy drinking is common in the United States and takes a personal and societal toll, with an annual estimated cost of $223.5 billion due to losses in workplace productivity, health care and criminal justice expenses.

16 Feb 2014

Mobile compression device just as effective as blood thinners in preventing DVT after joint surgery

Research from The Shiley Center for Orthopaedic Research and Education at Scripps Clinic could change how patients are treated to prevent blood clots after joint replacement surgery. A study published as the lead article in the current issue of the Journal of Bone and Joint Surgery determined that after lower extremity joint replacement surgery a mobile compression device was just as effective as blood thinners in preventing deep vein thrombosis (DVT), but without negative side effects including bleeding complications.

15 Feb 2014

Research roundup: Examining readmissions; easing doctor burnout

Despite massive early IT problems, exchange enrollment is accelerating rapidly. While enrollment may not reach 7 million by the end of March, we expect at least 5 million to have enrolled by the close of the initial open-enrollment period. If enrollment falls far short, HHS could extend open enrollment for a fixed period to reach its 7 million target. ... We project that 5 million new beneficiaries will be covered by Medicaid and the Children's Health Insurance Program by the end of 2014. Medicaid managed-care enrollment of non-dual beneficiaries will increase by 20 percent from 2013 to 2014 and by 38 percent from 2013 to 2016. We expect that 75 percent of non-dual Medicaid beneficiaries will be covered by Managed Care Organizations starting in 2015, up from 63 percent in 2012 (Feb. 2014).

14 Feb 2014

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that the National Institute of Allergy and Infectious Diseases has awarded Soligenix a Small Business Innovation Research grant to support further preclinical development of SGX943 as a treatment for melioidosis.

14 Feb 2014

Zilver PTX randomized trial of paclitaxel-eluting stents for femoropopliteal disease demonstrates superior results

Four-year results of the Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease continue to demonstrate consistent, superior results when compared to bare metal stents (BMS) and percutaneous transluminal angioplasty (PTA) in terms of primary patency, restenosis reduction and revascularization rates.

From COOK MEDICAL INC. 14 Feb 2014

Medicinewise News' edition examines latest evidence for determining absolute CVD risk, treatment options

NPS MedicineWise is reminding health professionals that while various media reports have recently linked statins to a variety of adverse events and questioned their efficacy, these drugs remain one of the most effective strategies for reducing the risk of cardiovascular disease (CVD).

14 Feb 2014

Viewpoints: Decoupling jobs and insurance; overblown fear: Medicaid willl take my house

Three blog posts and a column should probably suffice to cover the debate over Obamacare and work incentives, but I don't want to let the topic drop without first stepping back and talking about the actual health policy disagreement here.

14 Feb 2014

Topiramate reduces drinking in patients committed to abstinence from alcohol

Heavy drinking alcohol consumption is common in the United States and takes a personal and societal toll, with an annual estimated cost of $223.5 billion due to losses in workplace productivity, and health care and criminal justice expenses.

14 Feb 2014

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases, today announced that it has dosed the first patient in a Phase 2 trial evaluating AKB-9778, a Tie2 activator, alone and in combination with ranibizumab (Lucentis) for the treatment of diabetic macular edema (DME). AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leak.

13 Feb 2014

FDA grants full approval of SYNRIBO for injection

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has granted full approval of SYNRIBO (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

13 Feb 2014

CHOP develops unique laboratory test to characterize genes that encode HLA molecules

Immunogenetics experts at The Children's Hospital of Philadelphia (CHOP) have developed a unique laboratory test to characterize the genes that encode HLA molecules. The test relies on faster, more comprehensive gene sequencing technology to type human leukocyte antigens (HLAs)--complex, highly variable proteins on cell surfaces that are essential to immune function.

13 Feb 2014

Alvogen launches Inflectra into Central and Eastern Europe

Alvogen, the multinational pharmaceuticals company, today announced the launch of Inflectra (Infliximab) into Central and Eastern Europe. Inflectra, Europe's first biosimilar monoclonal antibody (mAb) therapy that has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.

13 Feb 2014

Cogstate technology to be applied in paediatric clinical trial in the U.S.

Medical technology company Cogstate Limited has today announced its technology will be used in a large paediatric clinical trial in the United States.

12 Feb 2014

Efficacy News and Research

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

Viamet announces positive interim results from VT-1161 Phase 2 study in patients with AVVC

GENFIT receives FDA Fast Track designation for GFT505 development program in NASH

New score ‘reliable and valid’ for neurogenic bladder dysfunction

Afatinib ‘first line’ for advanced mutation-positive lung cancer

Commonly-used HIV drug kills HPV that leads to cervical cancer

Research findings may help combat MRSA

Research findings have important implications for personalized treatment of alcohol abuse

Mobile compression device just as effective as blood thinners in preventing DVT after joint surgery

Research roundup: Examining readmissions; easing doctor burnout

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

Zilver PTX randomized trial of paclitaxel-eluting stents for femoropopliteal disease demonstrates superior results

Medicinewise News' edition examines latest evidence for determining absolute CVD risk, treatment options

Viewpoints: Decoupling jobs and insurance; overblown fear: Medicaid willl take my house

Topiramate reduces drinking in patients committed to abstinence from alcohol

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

FDA grants full approval of SYNRIBO for injection

CHOP develops unique laboratory test to characterize genes that encode HLA molecules

Alvogen launches Inflectra into Central and Eastern Europe

Cogstate technology to be applied in paediatric clinical trial in the U.S.

Industry Focus eBook - Neurology/Neuroscience - 2nd edition eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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