BG Medicine (BGMD) First U.S. Regulatory Clearance for Automated
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Posted On: 12/30/2014 4:05:53 PM
Parkinson's disease belongs to a group of conditions called motor system disorders, which are the result of the loss of dopamine-producing brain cells. The four primary symptoms of Parkinson's disease are tremor, or trembling in hands, arms, legs, jaw, and face; rigidity, or stiffness of the limbs and trunk; bradykinesia, or slowness of movement; and postural instability, or impaired balance and coordination. As these symptoms become more pronounced, patients may have difficulty walking, talking, or completing other simple tasks
Levodopa therapy is a principal medical treatment for the symptoms of Parkinson's disease. It successfully provides relief from the main symptoms of the condition and dramatically enhances the life of people with Parkinson's disease by improving motor function, mobility and enabling participation in everyday activities. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels.
Levodopa is almost always given in combination with another medication called Carbidopa. Carbidopa is also a levodopa enhancer. When added, carbidopa enables a much lower dose of levodopa and helps reduce the side effects of nausea and vomiting.
Due to the short half-life of oral levodopa, patients are required to take multiple levodopa/carbidopa (LD/CD) doses daily. This results in sharp fluctuations in levodopa levels which are associated with erratic "off" and "on" periods experienced by many patients. Continuous LD administration can overcome this limitation, but steady LD delivery can currently only be achieved after undergoing an invasive surgical procedure whereby a tube is permanently implanted into the duodenum, the upper part of the small intestine
NeuroDerm Ltd. (NDRM) reported that continuous, subcutaneous delivery of its proprietary liquid levodopa/carbidopa (LD/CD) product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels. These results suggest that the high dose version, ND0612H, intended for severe Parkinson's disease patients, may provide an effective therapy alternative to current treatments requiring surgery.
NDRM's ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD, maintaining steady, therapeutic levodopa plasma concentrations both day and night. ND0612H is intended to provide an alternative to surgical treatments associated with serious side effects that are currently offered to patients with severe Parkinson's disease.
NRDM is a clinical-stage pharmaceutical company developing central nervous system product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration.
More about NeuroDerm Ltd. (NDRM) at www.neuroderm.com
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BG Medicine, Inc. (BGMD) disclosed in a filing with the Securities and Exchange Commission (Form 8-K) that the U.S. Food and Drug Administration (FDA) made publicly available the 510(k) clearance for premarket notification number K140436, which represents the first automated version of galectin-3 testing to receive regulatory clearance in the United States.
BGMD is the developer of the BGM Galectin-3 Test, which is the FDA-cleared manual microtiter plate version of the galectin-3 test, and the licensor of this first automated galectin-3 assay, which is used with the Abbott (ABT) ARCHITECT fully-automated immunoassay analyzer. The new assay will be commercialized through an agreement between BGMD and Abbott Laboratories.
As cleared by the FDA, galectin-3 testing may be used by doctors in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The FDA clearance of the first automated assay represents a significant commercial milestone for BGMD and paves the way for the introduction of automated testing for galectin-3 throughout the United States.
BGMD believes that the introduction of automated galectin-3 testing will minimize objections related to the more labor intensive manual microtiter plate testing method, improve access to galectin-3 testing, shorten turn-around time for delivery of test results, and, as a result, accelerate adoption of galectin-3 testing in the United States.
Galectin-3 is a protein that is involved in fundamental disease processes including the development of fibrosis in organ tissues, and cardiac remodeling, which may lead to the development and progression of heart failure. Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care. Galectin-3 testing may be useful in helping physicians determine which patients are at higher risk of hospitalization or death.
BGMD, the developer of the BGM Galectin-3(R) Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders.
More about BG Medicine, Inc. (BGMD) at www.BG-Medicine.com.
**
Crown Equity Holdings Inc. (CRWE) provides marketing solutions that boost customer awareness and merchant visibility on the Internet
The company is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included Stockton, a city in and the county seat of San Joaquin County, north-central California ( www.stockton.crwe-pr.com ) to the CRWE Network.
Stockton, one of California's fastest growing communities, is located on the San Joaquin River, in the northern San Joaquin Valley. Historically an agricultural community, Stockton's economy has since diversified. These include telecommunications and manufacturing among others.
The City of Stockton had an estimated population in 2013 (U.S. Census Bureau) of 298,118, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
One of the primary goals of the CRWE Network is to offer business owners the power of consumer targeting advertisements on a local and national scale.
The CRWE Network has reached the 1486th community website in the U.S., associated with 3456 ZIP Codes, and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
Crown Equity Holdings' CRWE Press Release ( www.crwepressrelease.com ) offers increased visibility with cost effective solutions through the distribution of information to the entire CRWE Network for both public and private companies.
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
Levodopa therapy is a principal medical treatment for the symptoms of Parkinson's disease. It successfully provides relief from the main symptoms of the condition and dramatically enhances the life of people with Parkinson's disease by improving motor function, mobility and enabling participation in everyday activities. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels.
Levodopa is almost always given in combination with another medication called Carbidopa. Carbidopa is also a levodopa enhancer. When added, carbidopa enables a much lower dose of levodopa and helps reduce the side effects of nausea and vomiting.
Due to the short half-life of oral levodopa, patients are required to take multiple levodopa/carbidopa (LD/CD) doses daily. This results in sharp fluctuations in levodopa levels which are associated with erratic "off" and "on" periods experienced by many patients. Continuous LD administration can overcome this limitation, but steady LD delivery can currently only be achieved after undergoing an invasive surgical procedure whereby a tube is permanently implanted into the duodenum, the upper part of the small intestine
NeuroDerm Ltd. (NDRM) reported that continuous, subcutaneous delivery of its proprietary liquid levodopa/carbidopa (LD/CD) product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels. These results suggest that the high dose version, ND0612H, intended for severe Parkinson's disease patients, may provide an effective therapy alternative to current treatments requiring surgery.
NDRM's ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD, maintaining steady, therapeutic levodopa plasma concentrations both day and night. ND0612H is intended to provide an alternative to surgical treatments associated with serious side effects that are currently offered to patients with severe Parkinson's disease.
NRDM is a clinical-stage pharmaceutical company developing central nervous system product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration.
More about NeuroDerm Ltd. (NDRM) at www.neuroderm.com
**
BG Medicine, Inc. (BGMD) disclosed in a filing with the Securities and Exchange Commission (Form 8-K) that the U.S. Food and Drug Administration (FDA) made publicly available the 510(k) clearance for premarket notification number K140436, which represents the first automated version of galectin-3 testing to receive regulatory clearance in the United States.
BGMD is the developer of the BGM Galectin-3 Test, which is the FDA-cleared manual microtiter plate version of the galectin-3 test, and the licensor of this first automated galectin-3 assay, which is used with the Abbott (ABT) ARCHITECT fully-automated immunoassay analyzer. The new assay will be commercialized through an agreement between BGMD and Abbott Laboratories.
As cleared by the FDA, galectin-3 testing may be used by doctors in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The FDA clearance of the first automated assay represents a significant commercial milestone for BGMD and paves the way for the introduction of automated testing for galectin-3 throughout the United States.
BGMD believes that the introduction of automated galectin-3 testing will minimize objections related to the more labor intensive manual microtiter plate testing method, improve access to galectin-3 testing, shorten turn-around time for delivery of test results, and, as a result, accelerate adoption of galectin-3 testing in the United States.
Galectin-3 is a protein that is involved in fundamental disease processes including the development of fibrosis in organ tissues, and cardiac remodeling, which may lead to the development and progression of heart failure. Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care. Galectin-3 testing may be useful in helping physicians determine which patients are at higher risk of hospitalization or death.
BGMD, the developer of the BGM Galectin-3(R) Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders.
More about BG Medicine, Inc. (BGMD) at www.BG-Medicine.com.
**
Crown Equity Holdings Inc. (CRWE) provides marketing solutions that boost customer awareness and merchant visibility on the Internet
The company is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included Stockton, a city in and the county seat of San Joaquin County, north-central California ( www.stockton.crwe-pr.com ) to the CRWE Network.
Stockton, one of California's fastest growing communities, is located on the San Joaquin River, in the northern San Joaquin Valley. Historically an agricultural community, Stockton's economy has since diversified. These include telecommunications and manufacturing among others.
The City of Stockton had an estimated population in 2013 (U.S. Census Bureau) of 298,118, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
One of the primary goals of the CRWE Network is to offer business owners the power of consumer targeting advertisements on a local and national scale.
The CRWE Network has reached the 1486th community website in the U.S., associated with 3456 ZIP Codes, and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
Crown Equity Holdings' CRWE Press Release ( www.crwepressrelease.com ) offers increased visibility with cost effective solutions through the distribution of information to the entire CRWE Network for both public and private companies.
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
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