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FDA approves Velomedix’s IDE to expand design of VELOCITY trial for heart attack

Velomedix, Inc., a venture-backed medical device company advancing the field of therapeutic hypothermia, announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to expand the design of its VELOCITY pilot clinical trial.

29 Nov 2012

NuFACE receives FDA clearance for Trinity Facial Toning Device

NuFACE is thrilled to announce the launch the FDA cleared Trinity Wrinkle Remover, a red light attachment for the NuFACE Trinity Facial Toning Device. The removable attachment is engineered with advanced LEDs to deliver a precise combination of red and infrared light therapy treatments to reduce full face wrinkles.

29 Nov 2012

Dutasteride delays PSA progression

The 5α-reductase inhibitor, dutasteride, delays the clinical progression of prostate cancer in patients with prostate-specific antigen levels that have failed to reduce adequately following radical therapy for localized disease, report researchers.

28 Nov 2012

Hemorrhage risk ‘higher than reported’ for AF warfarin users

Real-world findings for atrial fibrillation patients using warfarin point to a significantly higher risk for hemorrhage than reported for clinical trials.

28 Nov 2012

Combination of mixed amphetamine salts and topiramate shows promise for cocaine dependence

Medication development efforts for cocaine dependence have yet to result in an FDA approved treatment. The powerful rewarding effects of cocaine, the profound disruptive impact of cocaine dependence on one's lifestyle, and the tendency of cocaine to attract people who make poor life choices and then exacerbate impulsive behavior all make cocaine a vexing clinical condition.

28 Nov 2012

Trovagene develops first molecular diagnostic test to detect KRAS mutations from urine samples

Trovagene, Inc. today announced successful development of its first molecular diagnostic test capable of detecting KRAS mutations from a urine specimen. Transfer of the transrenal KRAS test to the company's CLIA lab is expected to be completed in December 2012 with commercial availability expected in January 2013.

28 Nov 2012

Warfarin treatment after aortic valve replacement reduces risk of cardiovascular death

Although current guidelines recommend 3 months of anticoagulation treatment after bioprosthetic aortic valve replacement surgery, a study that included more than 4,000 patients found that patients who had warfarin therapy continued between 3 and 6 months after surgery had a lower rate of cardiovascular death, according to a study in the November 28 issue of JAMA.

28 Nov 2012

Contralateral prophylactic mastectomy does not reduce breast cancer recurrence

About 70 percent of women who have both breasts removed following a breast cancer diagnosis do so despite a very low risk of facing cancer in the healthy breast, new research from the University of Michigan Comprehensive Cancer Center finds.

28 Nov 2012

Injecting Wnt7a protein could prevent Duchenne muscular dystrophy

Scientists have discovered that injecting a novel human protein into muscle affected by Duchenne muscular dystrophy significantly increases its size and strength, findings that could lead to a therapy akin to the use of insulin by diabetics.

28 Nov 2012

Prevalence of mental health diagnoses increases with long duration of opioid use

Most patients taking opioids for low back pain or other pain syndromes are prescribed low-to moderate doses, but a substantial number are given higher doses. Although there is no consensus on an absolute limit because tolerance varies over time among individual patients, what is known, however, is higher does are associated with elevated risks for side effects, addiction, overdoses and death.

28 Nov 2012

Intramyocardial injection of organ-derived stem cells after AMI improves left ventricle function

A study published in the current issue of Cell Transplantation, now freely available on-line, has found that when mesenchymal cells derived from skeletal muscle (SM-MSCs) or adipose tissue (ADSCs) were injected into the heart muscle (myocardium) of separate groups of laboratory rats that had suffered a myocardial infarction, rats in both groups experienced significantly improved left ventricle function and smaller infarct size after cell therapy.

28 Nov 2012

Merrimack’s MM-302 Phase I results and MM-DX-929 preclinical data to be presented at SABCS

Merrimack Pharmaceuticals, Inc. today announced that Phase I data evaluating the novel agent MM-302 for the treatment of advanced HER2+ breast cancer and preclinical data on potential imaging and biomarker-based diagnostics will be presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), Dec. 4-8, 2012 in San Antonio, Texas.

28 Nov 2012

Enrollment begins in Elan’s ELND005 Phase 2 trial for agitation/aggression associated with AD

Elan Corporation, plc today announced that it has enrolled the first patient in a Phase 2 clinical trial of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer's disease (AD).

28 Nov 2012

Immediate behavioral intervention effective in reducing PTSD

Posttraumatic stress disorder (PTSD) is a form of learning that begins at the moment of the exposure to extremely stressful situations and that grows in impact as trauma-related memories are rehearsed and strengthened repeatedly.

28 Nov 2012

Post-prostatectomy erectile dysfunction treatment disliked

Less than half of men who initiate intracorporeal injections for post-prostatectomy erectile dysfunction are still satisfied with the treatment years later, report researchers.

27 Nov 2012

Amarantus demonstrates excellent diffusion profile of MANF in the striatum of rat brains

Amarantus BioSciences, Inc., a biotechnology company developing new disease-modifying treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centered on its proprietary anti-apoptosis therapeutic protein MANF, today announced that the Company has successfully completed experiments demonstrating that MANF has an excellent diffusion profile in the striatum of rat brains.

27 Nov 2012

New coverage decisions by private payers and Medicare for OAB and urge incontinence

Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced significant new coverage decisions by private payers and Medicare.

27 Nov 2012

FDA clears Avaxia’s AVX-470 IND for treatment of ulcerative colitis

Avaxia Biologics, Inc., a privately-held biotechnology company developing oral antibody drugs that act locally within the digestive tract, announced today that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for AVX-470 for the treatment of ulcerative colitis.

27 Nov 2012

Liver disease therapies: an interview with Eric Halioua, CEO of Promethera Biosciences

Liver disease is a very broad family of diseases. There are two main categories of liver disease:

27 Nov 2012

Buying mail-order medications may encourage patients to stick their treatments

Patients newly prescribed a cholesterol-lowering medication were more likely to pick it up from the pharmacy if they received automated phone and mail reminders, according to a study published in the Archives of Internal Medicine today.

27 Nov 2012

Therapy News and Research

FDA approves Velomedix’s IDE to expand design of VELOCITY trial for heart attack

NuFACE receives FDA clearance for Trinity Facial Toning Device

Dutasteride delays PSA progression

Hemorrhage risk ‘higher than reported’ for AF warfarin users

Combination of mixed amphetamine salts and topiramate shows promise for cocaine dependence

Trovagene develops first molecular diagnostic test to detect KRAS mutations from urine samples

Warfarin treatment after aortic valve replacement reduces risk of cardiovascular death

Contralateral prophylactic mastectomy does not reduce breast cancer recurrence

Injecting Wnt7a protein could prevent Duchenne muscular dystrophy

Prevalence of mental health diagnoses increases with long duration of opioid use

Intramyocardial injection of organ-derived stem cells after AMI improves left ventricle function

Merrimack’s MM-302 Phase I results and MM-DX-929 preclinical data to be presented at SABCS

Enrollment begins in Elan’s ELND005 Phase 2 trial for agitation/aggression associated with AD

Immediate behavioral intervention effective in reducing PTSD

Post-prostatectomy erectile dysfunction treatment disliked

Amarantus demonstrates excellent diffusion profile of MANF in the striatum of rat brains

New coverage decisions by private payers and Medicare for OAB and urge incontinence

FDA clears Avaxia’s AVX-470 IND for treatment of ulcerative colitis

Liver disease therapies: an interview with Eric Halioua, CEO of Promethera Biosciences

Buying mail-order medications may encourage patients to stick their treatments

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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