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Nationwide researchers to launch Oncotype DX test phase III trial in breast cancer

Cancer researchers at hundreds of sites nationwide are about to launch a SWOG-led clinical trial that could keep thousands of breast cancer patients from getting chemotherapy that is unlikely to do them any good.

27 Apr 2011

Boehringer Ingelheim initiates enrollment in BI 201335 Phase 3 clinical trial for chronic HCV

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that enrollment has commenced at North American sites in its pivotal Phase 3 clinical trial program for BI 201335, the Company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

27 Apr 2011

Brookside Surgery Center to participate in iUni G2 knee implant trial

Dr. Joseph Burkhardt of Brookside Surgery Center is participating in a ten year follow-up trial of the ConforMIS iUni G2 knee resurfacing device, an FDA cleared implant for patients with osteoarthritic damage in a single compartment of the knee.

27 Apr 2011

IQ Therapeutics completes dosing in IQNLF Phase I trial for anthrax

IQ Therapeutics has completed the dosing of antibody IQNLF in a Phase I clinical trial. A total of 36 healthy volunteers participated in the randomized, placebo controlled, double blind, single dose-escalating study, intended to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IQNLF.

27 Apr 2011

FDA grants orphan drug status to Provectus' PV-10 for liver cancer treatment

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has received orphan drug designation by the U.S. Food and Drug Administration for Rose Bengal, the active ingredient in its novel oncology drug PV-10, for the treatment of hepatocellular carcinoma, the most common form of primary liver cancer.

27 Apr 2011

Diabetes and prediabetes are on the rise: New medication in research trials

As the newest statistics from the CDC show, diabetes is an ever increasing problem for Americans. Almost 26 million adults in this country now have diabetes, an increase of 9% since 2008. Ninety to 95% of cases are type 2 diabetes, marked by a gradual inability of the body’s cells to respond to insulin, and eventually an inability to produce enough insulin. In addition, almost 79 million people in this country have prediabetes. The CDC has warned that if diabetes continues on its current course, it could affect a third of all adult Americans by 2050.

26 Apr 2011

Common painkillers decrease effectiveness of antidepressants: Study

According to a latest study, antidepressants like Prozac and Aspirin do not mix. Researchers found that painkillers such as aspirin and ibuprofen appear to decrease the effectiveness of a popular class of antidepressants that includes Prozac, Paxil, Lexapro and Zoloft and Celexa.

26 Apr 2011

PolyMedix defensin-mimetic antibiotic compounds show antimicrobial efficacy against anthrax

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat patients with acute infectious diseases and cardiovascular disorders, announced today that several of its defensin-mimetic antibiotic compounds have shown antimicrobial efficacy in an animal model against the bacteria that causes anthrax.

26 Apr 2011

Colorectal cancer patients with genetic mutation can benefit from new class of drugs

A class of drugs that shows promise in breast and ovarian cancers with BRCA gene mutations could potentially benefit colorectal cancer patients with a different genetic mutation, a new study from the University of Michigan Comprehensive Cancer Center finds.

26 Apr 2011

Men with high DHA levels may face risk of developing aggressive prostate cancer

The largest study ever to examine the association of dietary fats and prostate cancer risk has found what's good for the heart may not be good for the prostate.

26 Apr 2011

KemPharm to formulate and develop KP106 as oral film dosage for ADHD treatment

KemPharm, Inc. today announced that KP106, its clinical candidate for Attention Deficit/Hyperactivity Disorder, will be formulated and developed in an oral film dosage form pursuant to an exclusive collaboration agreement with MonoSol Rx relating to the development, commercialization and manufacture of KP106.

26 Apr 2011

Alkem, Karo Bio partner to license eprotirome

Karo Bio has entered into a collaboration and license agreement with the Indian pharmaceutical company Alkem Laboratories Ltd.

26 Apr 2011

Dactinomycin more effective for low-risk gestational tumor treatment

A clinical trial has sifted out the most effective single-drug chemotherapy regimen for quick-growing but highly curable cancers that arise from the placentas of pregnant women.

26 Apr 2011

ACC/AHA release consensus document to help clinicians reduce risk of hypertension in older adults

Hypertension is very common among older adults. 64 percent of older men and 78 percent of older women have high blood pressure, placing them at heightened risk for heart disease including heart failure, stroke, coronary artery disease and atrial fibrillation, as well as chronic kidney disease and diabetes mellitus.

26 Apr 2011

Study questions suitability of anti-retroviral drugs for the young

According to a new major study one in eight children born with HIV becomes resistant to the three main classes of drugs used to suppress the virus within five years of starting treatment. This is the first major study that looks at drug resistance in 1,000 European children born with HIV. It raises questions about the suitability of anti-retroviral drugs for the young.

25 Apr 2011

MonoSol Rx, KemPharm enter development and commercialization partnership for ADHD prodrug

MonoSol Rx, LLC, the developer of PharmFilm® drug delivery technology, today announced that the Company has entered into a development and commercialization partnership with KemPharm, a biopharmaceutical company focused on the discovery and development of new, safer therapies for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), pain, and cardiovascular disease.

25 Apr 2011

XenoPort files SPA with FDA for arbaclofen placarbil Phase 3 trial in multiple sclerosis

XenoPort, Inc. announced today that it had reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for a pivotal Phase 3 clinical trial of arbaclofen placarbil, previously known as XP19986, as a potential treatment of spasticity in multiple sclerosis patients.

25 Apr 2011

U-M receives Taubman Institute's $100 million gift for innovative medical science

A. Alfred Taubman has become U-M's largest individual donor, with total giving of more than $142 million. His latest gift of $56 million to the A. Alfred Taubman Medical Research Institute, announced today before the University's Board of Regents, will bring his support of innovative medical science at the University of Michigan to a total of $100 million.

25 Apr 2011

nSpire Health sales increase 3% to $27.6M for 2011

nSpire Health, LLC, a leading provider of respiratory diagnostic devices and clinical trial services, issued audited results for 2010 today. Sales of $27.6M are up 3% year over year. The Company reported a $3.6M improvement in EBIT when compared to 2009 and its highest profit since the founding of the company in 2006. Cash is up $2.4M and debt reduced to less than $400K.

25 Apr 2011

Maxwell Biotech, Sequella enter license agreement to commercialize SQ109 for TB treatment

Sequella, a clinical-stage pharmaceutical company focused on commercializing novel antibiotics to treat life-threatening infectious diseases, and Maxwell Biotech Venture Fund announced their agreement to complete the clinical development and commercialize SQ109 for treatment of tuberculosis in the Russian Federation and neighboring Commonwealth of Independent States countries, including Armenia, Azerbaijan, Belorussia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Ukraine.

25 Apr 2011

Clinical Trial News and Research

Nationwide researchers to launch Oncotype DX test phase III trial in breast cancer

Boehringer Ingelheim initiates enrollment in BI 201335 Phase 3 clinical trial for chronic HCV

Brookside Surgery Center to participate in iUni G2 knee implant trial

IQ Therapeutics completes dosing in IQNLF Phase I trial for anthrax

FDA grants orphan drug status to Provectus' PV-10 for liver cancer treatment

Diabetes and prediabetes are on the rise: New medication in research trials

Common painkillers decrease effectiveness of antidepressants: Study

PolyMedix defensin-mimetic antibiotic compounds show antimicrobial efficacy against anthrax

Colorectal cancer patients with genetic mutation can benefit from new class of drugs

Men with high DHA levels may face risk of developing aggressive prostate cancer

KemPharm to formulate and develop KP106 as oral film dosage for ADHD treatment

Alkem, Karo Bio partner to license eprotirome

Dactinomycin more effective for low-risk gestational tumor treatment

ACC/AHA release consensus document to help clinicians reduce risk of hypertension in older adults

Study questions suitability of anti-retroviral drugs for the young

MonoSol Rx, KemPharm enter development and commercialization partnership for ADHD prodrug

XenoPort files SPA with FDA for arbaclofen placarbil Phase 3 trial in multiple sclerosis

U-M receives Taubman Institute's $100 million gift for innovative medical science

nSpire Health sales increase 3% to $27.6M for 2011

Maxwell Biotech, Sequella enter license agreement to commercialize SQ109 for TB treatment

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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