February 26, '09: Acorda Therapeutics Submits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
Category: Misc. Meds for MS Treatment
Posted by: stuart
Drugs.com
New Drug Application (NDA) Submitted for Fampridine-SR ( 4-aminopyridine [4AP] )
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Feb 2, 2009 - Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The Company expects that the NDA filing, if accepted, will be subject to standard review, which would provide a target for the FDA to complete its review within ten months from receipt of the submission.
=============================================New Drug Application (NDA) Submitted for Fampridine-SR ( 4-aminopyridine [4AP] )
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Feb 2, 2009 - Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The Company expects that the NDA filing, if accepted, will be subject to standard review, which would provide a target for the FDA to complete its review within ten months from receipt of the submission.
February 18, '09: MS Prize of $1.3 Billion Spurs Merck KGaA, Novartis!
Category: Misc. Meds for MS Treatment
Posted by: stuart
MS Prize of $1.3 Billion Spurs Merck KGaA, Novartis!
http://www.bloomberg.com/apps/news?pid=20601109&sid=a4EfOSGwR87A&refer=home
Feb. 13 (Bloomberg) -- Merck KGaA and Novartis AG are racing to market the first multiple sclerosis pill, a prize that may generate $1.3 billion a year in sales as patients switch from injectable drugs.
Merck and Novartis plan to ask regulators this year to approve tablets to fight the incurable illness. Initial test data showed that patients who took the drugs had fewer disease flare- ups than those who received placebo or existing treatments.
A pill may mean an end to painful injections or infusions that can cost $28,000 a year to control multiple sclerosis, which can rob people of their mobility and leave them with chronic aches and depression. Merck, of Darmstadt, Germany, and Novartis, of Basel, Switzerland, are running ahead of Teva Pharmaceutical Industries Ltd., Biogen Idec Inc. and Sanofi-Aventis SA in the chase for an oral treatment. The results may shake up the $6 billion multiple sclerosis market.
=============================================http://www.bloomberg.com/apps/news?pid=20601109&sid=a4EfOSGwR87A&refer=home
Feb. 13 (Bloomberg) -- Merck KGaA and Novartis AG are racing to market the first multiple sclerosis pill, a prize that may generate $1.3 billion a year in sales as patients switch from injectable drugs.
Merck and Novartis plan to ask regulators this year to approve tablets to fight the incurable illness. Initial test data showed that patients who took the drugs had fewer disease flare- ups than those who received placebo or existing treatments.
A pill may mean an end to painful injections or infusions that can cost $28,000 a year to control multiple sclerosis, which can rob people of their mobility and leave them with chronic aches and depression. Merck, of Darmstadt, Germany, and Novartis, of Basel, Switzerland, are running ahead of Teva Pharmaceutical Industries Ltd., Biogen Idec Inc. and Sanofi-Aventis SA in the chase for an oral treatment. The results may shake up the $6 billion multiple sclerosis market.
September 18, '08: Multiple Sclerosis: Biogen Idec Testing Regenerative Medicine Drug to Reverse the Path of MS
Category: Misc. Meds for MS Treatment
Posted by: stuart
Contributed by Trent S in Miami
xconomy.com
Biogen Idec Testing Regenerative Medicine Drug to Reverse the Path of Multiple Sclerosis
Luke Timmerman 8/27/08
Biogen Idec has made a lot of its money on Avonex and Tysabri, drugs that slow down the rate of flare-ups for people with multiple sclerosis. Now the Cambridge, MA-based biotech company (NASDAQ: BIIB) is pursuing a loftier goal. It is working on the first experimental drug that may reverse the symptoms of the neurodegenerative disease.
The drug, being tested in animals and prepped for its first human trial, is designed to block a protein called Lingo-1 that interferes with body’s production of myelin, the fatty protective coating around nerve fibers.
=============================================xconomy.com
Biogen Idec Testing Regenerative Medicine Drug to Reverse the Path of Multiple Sclerosis
Luke Timmerman 8/27/08
Biogen Idec has made a lot of its money on Avonex and Tysabri, drugs that slow down the rate of flare-ups for people with multiple sclerosis. Now the Cambridge, MA-based biotech company (NASDAQ: BIIB) is pursuing a loftier goal. It is working on the first experimental drug that may reverse the symptoms of the neurodegenerative disease.
The drug, being tested in animals and prepped for its first human trial, is designed to block a protein called Lingo-1 that interferes with body’s production of myelin, the fatty protective coating around nerve fibers.
September 11, '08: Rituxan Therapy for MS and other diseases has New IMPORTANT DRUG WARNING
Category: Misc. Meds for MS Treatment
Posted by: stuart
September 2008
IMPORTANT DRUG WARNING NEW SAFETY INFORMATION
Dear Healthcare Professional:
Genentech, Inc. and Biogen Idec, Inc. would like to inform you of important new safety information regarding Rituxan® (rituximab).
A case of progressive multifocal leukoencephalopathy (PML) leading to death has been reported in a patient with rheumatoid arthritis (RA) who received Rituxan in a long-term safety extension clinical study. This is the first reported case of PML in a Rituxan-treated patient with RA of oropharyngeal cancer, which was treated with chemotherapy (a platinum containing regimen) and radiation therapy 9 months prior to the development of PML. The patient had longstanding RA treated with immunosuppressants and a complex medical and rheumatologic history including Sjogren’s syndrome and undetectable complement C4 levels. Treatment for RA included methotrexate, steroids, and a TNF antagonist prior to Rituxan therapy; and methotrexate and steroids during and after Rituxan therapy.
=============================================IMPORTANT DRUG WARNING NEW SAFETY INFORMATION
Dear Healthcare Professional:
Genentech, Inc. and Biogen Idec, Inc. would like to inform you of important new safety information regarding Rituxan® (rituximab).
A case of progressive multifocal leukoencephalopathy (PML) leading to death has been reported in a patient with rheumatoid arthritis (RA) who received Rituxan in a long-term safety extension clinical study. This is the first reported case of PML in a Rituxan-treated patient with RA of oropharyngeal cancer, which was treated with chemotherapy (a platinum containing regimen) and radiation therapy 9 months prior to the development of PML. The patient had longstanding RA treated with immunosuppressants and a complex medical and rheumatologic history including Sjogren’s syndrome and undetectable complement C4 levels. Treatment for RA included methotrexate, steroids, and a TNF antagonist prior to Rituxan therapy; and methotrexate and steroids during and after Rituxan therapy.
September 04, '08: Opexa Therapeutics and Myelin Repair Foundation Partner on Novel Multiple Sclerosis Research Program
Category: Misc. Meds for MS Treatment
Posted by: stuart
Market Watch Business Wire
Collaboration to Identify Therapeutically Relevant Biomarkers and Offer Key Insight for Further Clinical Development of Tovaxin(R)
Last update: 7:30 a.m. EDT Sept. 3, 2008
THE WOODLANDS, Texas, Sep 03, 2008 (BUSINESS WIRE) -- Opexa Therapeutics, Inc. a company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS) and diabetes, today announced the establishment of a novel MS research partnership with the Myelin Repair Foundation, Inc. (MRF). As part of this collaboration, Opexa and the MRF will work to identify therapeutically relevant biomarkers in MS that may provide important insight to support the continued development of Tovaxin(R), Opexa's T-cell vaccine currently in Phase IIb clinical testing in MS patients. In addition, biomarkers identified as part of the research program may also assist in guiding the discovery and development of novel diagnostics and treatments for MS.
=============================================Collaboration to Identify Therapeutically Relevant Biomarkers and Offer Key Insight for Further Clinical Development of Tovaxin(R)
Last update: 7:30 a.m. EDT Sept. 3, 2008
THE WOODLANDS, Texas, Sep 03, 2008 (BUSINESS WIRE) -- Opexa Therapeutics, Inc. a company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS) and diabetes, today announced the establishment of a novel MS research partnership with the Myelin Repair Foundation, Inc. (MRF). As part of this collaboration, Opexa and the MRF will work to identify therapeutically relevant biomarkers in MS that may provide important insight to support the continued development of Tovaxin(R), Opexa's T-cell vaccine currently in Phase IIb clinical testing in MS patients. In addition, biomarkers identified as part of the research program may also assist in guiding the discovery and development of novel diagnostics and treatments for MS.
August 20, '08: Multiple Sclerosis News: New drugs in late-stage trials offer promise for sufferers of the chronic and crushing disease
Category: Misc. Meds for MS Treatment
Posted by: stuart
Joy C. in Miami, informed me of this article.. My thanks to Joy...
Mary Ellen Egan 08.07.08, 6:00 PM ET
Forbes issue date 09.01.08
{as of today (August 20, 2008), this is not yet in print}
New drugs in late-stage trials offer promise for sufferers of the chronic
and crushing disease multiple sclerosis
Robin Giese, 59, kicks off each day by getting out of her wheelchair for a half-hour ride on a stationary bike followed by 30 minutes of stretching exercises. Most afternoons she visits friends or one of of her five grandchildren, and in the evenings she and her husband, Clifford, entertain guests or go out to dinner.
Giese hasn't always been so active. She has multiple sclerosis, the degenerative disease of the central nervous system that afflicts 400,000 Americans. In MS the immune system attacks myelin, a fatty substance that protects nerve fibers much the way insulation protects electrical wires. When the unprotected nerve fibers, or axons, are damaged, signals are blocked or delayed traveling to and from the brain. This causes a variety of symptoms that can include blurred vision, incontinence, difficulty walking and paralysis.
=============================================
Two Steps Forward
Mary Ellen Egan 08.07.08, 6:00 PM ET
Forbes issue date 09.01.08
{as of today (August 20, 2008), this is not yet in print}
New drugs in late-stage trials offer promise for sufferers of the chronic
and crushing disease multiple sclerosis
Robin Giese, 59, kicks off each day by getting out of her wheelchair for a half-hour ride on a stationary bike followed by 30 minutes of stretching exercises. Most afternoons she visits friends or one of of her five grandchildren, and in the evenings she and her husband, Clifford, entertain guests or go out to dinner.
Giese hasn't always been so active. She has multiple sclerosis, the degenerative disease of the central nervous system that afflicts 400,000 Americans. In MS the immune system attacks myelin, a fatty substance that protects nerve fibers much the way insulation protects electrical wires. When the unprotected nerve fibers, or axons, are damaged, signals are blocked or delayed traveling to and from the brain. This causes a variety of symptoms that can include blurred vision, incontinence, difficulty walking and paralysis.
Category: Misc. Meds for MS Treatment
Posted by: stuart
In power of vitamin D, hope for a new disease fighter
by Carol Ann Campbell/The Star-Ledger
Monday July 14, 2008, 4:39 AM
In a Newark laboratory, researchers watch as mice stricken with multiple sclerosis suddenly walk. They peer into microscopes and see the growth of breast cancer cells dramatically slowed.
They are examining, up close, the power of vitamin D.
"We're believers," said Sylvia Christakos, a longtime vitamin researcher at UMDNJ-New Jersey Medical School.
Many others are following. A spate of provocative studies shows the potential health benefits of vitamin D on everything from breast, prostate and colon cancer to auto- immune disorders such as Type I diabetes, rheumatoid arthritis, lupus and multiple sclerosis.
=============================================by Carol Ann Campbell/The Star-Ledger
Monday July 14, 2008, 4:39 AM
In a Newark laboratory, researchers watch as mice stricken with multiple sclerosis suddenly walk. They peer into microscopes and see the growth of breast cancer cells dramatically slowed.
They are examining, up close, the power of vitamin D.
"We're believers," said Sylvia Christakos, a longtime vitamin researcher at UMDNJ-New Jersey Medical School.
Many others are following. A spate of provocative studies shows the potential health benefits of vitamin D on everything from breast, prostate and colon cancer to auto- immune disorders such as Type I diabetes, rheumatoid arthritis, lupus and multiple sclerosis.
March 28, '08: Recall of Medtronic's Intrathecal Infusion Pumps
Category: Misc. Meds for MS Treatment
Posted by: stuart
FDA has recalled the pump, as noted in the medscape link below.
Submitted by: Cherie C. Binns RN BS MSCN
----------------------------------------------
Medscape Medical Alert
Medscape
March 25, 2008 — A class 1 recall has been announced for Medtronic Neuromodulation's implantable infusion pumps, the US Food and Drug Administration (FDA) announced on March 21.
Affected devices include SynchroMed EL (models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, and 8627L-18), SynchroMed II (models 8637-20 and 8637-40), and IsoMed (models 8472-20, 8472-35, and 8472-60).
=============================================Submitted by: Cherie C. Binns RN BS MSCN
----------------------------------------------
Medscape Medical Alert
Medscape
March 25, 2008 — A class 1 recall has been announced for Medtronic Neuromodulation's implantable infusion pumps, the US Food and Drug Administration (FDA) announced on March 21.
Affected devices include SynchroMed EL (models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, and 8627L-18), SynchroMed II (models 8637-20 and 8637-40), and IsoMed (models 8472-20, 8472-35, and 8472-60).
February 06, '08: Multiple Sclerosis: Intrathecal Baclofen Pump Therapy
Category: Misc. Meds for MS Treatment
Posted by: stuart
Intrathecal Baclofen Pump Therapy
Baclofen is a medication commonly used to decrease spasticity related to multiple sclerosis, spinal cord injuries, or other neurological diseases. Spasticity is a muscle problem characterized by tight or stiff muscles that may interfere with voluntary muscle movements.
How Does Baclofen Work?
Normally muscles receive electrical signals via nerves to contract and relax. Spasticity is caused by an imbalance of electrical signals coming from the spinal cord through the nerves to the muscle. This imbalance causes the muscle to become hyperactive, resulting in involuntary spasms. Baclofen works by restoring the normal balance and reducing muscle hyperactivity. In this way, it allows for more normal muscle movements.
=============================================Baclofen is a medication commonly used to decrease spasticity related to multiple sclerosis, spinal cord injuries, or other neurological diseases. Spasticity is a muscle problem characterized by tight or stiff muscles that may interfere with voluntary muscle movements.
How Does Baclofen Work?
Normally muscles receive electrical signals via nerves to contract and relax. Spasticity is caused by an imbalance of electrical signals coming from the spinal cord through the nerves to the muscle. This imbalance causes the muscle to become hyperactive, resulting in involuntary spasms. Baclofen works by restoring the normal balance and reducing muscle hyperactivity. In this way, it allows for more normal muscle movements.
January 23, '08: Adrenocorticotropic Hormone (ACTH)
Category: Misc. Meds for MS Treatment
Posted by: stuart
From The MS Information Sourcebook, produced by the National MS Society.
Following clinical trials in the 1960s, adrenocorticotropic hormone (ACTH, manufactured as H.P. Acthar® Gel) was approved in 1978 by the U.S. Food and Drug Administration (FDA) as a short-term treatment for acute exacerbations in multiple sclerosis. ACTH is an anterior pituitary hormone that stimulates the adrenal cortex to secrete cortisol, aldosterone, and other substances. Increased secretion of these natural steroids provides an anti-inflammatory and immunosuppressive effect to hasten recovery from an MS exacerbation. While it has not been demonstrated that ACTH affects the long-term course of the disease, its administration has consistently been shown to shorten the duration of attacks.
=============================================
Following clinical trials in the 1960s, adrenocorticotropic hormone (ACTH, manufactured as H.P. Acthar® Gel) was approved in 1978 by the U.S. Food and Drug Administration (FDA) as a short-term treatment for acute exacerbations in multiple sclerosis. ACTH is an anterior pituitary hormone that stimulates the adrenal cortex to secrete cortisol, aldosterone, and other substances. Increased secretion of these natural steroids provides an anti-inflammatory and immunosuppressive effect to hasten recovery from an MS exacerbation. While it has not been demonstrated that ACTH affects the long-term course of the disease, its administration has consistently been shown to shorten the duration of attacks.
