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Biogen, Elan seek okay for first-line Tysabri use in MS

Posted: Published on January 17th, 2013

LONDON (Reuters) - Biogen Idec and Elan have filed for approval to sell their drug Tysabri as a first-line treatment for multiple sclerosis, a move that could boost sales of the drug. Demand for Tysabri has been curtailed due to concerns over its association with a potentially fatal infection known as progressive multifocal leukoencephalopathy, or PML, which is caused by the JC virus. Now, however, there is a test for the virus to predict if patients are at risk of developing PML, opening the possibility that Tysabri could be used more widely and at an earlier stage of treatment. Biogen and Elan said on Wednesday they had submitted applications to the U.S. Food and Drug Administration and the European Medicines Agency seeking approval for first-line use in patients with relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus. The JC virus is generally harmless, but in people with weakened immune systems, such as those using immune system-suppressing drugs like Tysabri, it can lead to an increased chance of developing PML. Tysabri use is currently limited to between 10 and 12 percent of treated MS patients, due to the risk of PML, and analysts … Continue reading →

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Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in anti-JCV Antibody Negative Patients with MS

Posted: Published on January 17th, 2013

WESTON, Mass. & DUBLIN--(BUSINESS WIRE)-- Today Biogen Idec (BIIB) and Elan Corporation, plc (ELN) announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus (JCV). A formal assessment of both applications is ongoing. These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with TYSABRI. If approved, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider TYSABRI early in the course of treatment, regardless of the level of disease activity or prior treatment history. TYSABRI is a highly efficacious treatment that has been shown to slow disability progression by 42 54 percent and reduce annualized relapse rates by 68 percent. Our anti-JCV antibody test, STRATIFY JCV, helps to determine the most appropriate patients for TYSABRI and the data collected to date supports our recent filing for first-line use, said Alfred Sandrock, … Continue reading →

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International Clinical Trial Uses Iron Chelation Drug to Treat Rare, Devastating Neurodegenerative Disease in Children

Posted: Published on January 17th, 2013

Childrens Hospital & Research Center Oaklands promising pilot study of deferiprone for the treatment of the neurodegenerative disorder, PKAN, leads to an international trial with potential implications for Parkinsons and other neurodegenerative diseases. Newswise January 16, 2013, Oakland, Calif. A groundbreaking, international clinical trial of an iron chelation drug, deferiprone, to treat the rare and devastating neurodegenerative disease, pantothenate kinase-associated neurodegeneration (PKAN), began last month at the trials only North American site, Childrens Hospital & Research Center Oakland. Childrens Oakland is one of six clinical centers participating in an international consortium called Treat Iron-Related Childhood-Onset Neurodegeneration (TIRCON). The international consortium is studying the effect of deferiprone on patients with this rare, inherited nervous system disorder characterized by iron build-up in the brain and progressive difficulty with movement, speech and vision, which eventually proves fatal in children and teens. Elliott Vichinsky, MD, Childrens Oaklands Director of Hematology/Oncology and an expert in iron disorders, obtained FDA Investigational New Drug (IND) approval for pilot treatment of PKAN patients with deferiprone, the only oral iron chelator that crosses the blood-brain barrier. In 2007, Dr. Vichinskys patient, Brent, then 13, was one of the first patients to receive deferiprone for PKAN. News of Brents and … Continue reading →

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Sub-Group Analysis Of Data From Pediatric Patients With Hereditary Angioedema Published In The Journal Of Pediatrics

Posted: Published on January 17th, 2013

EXTON, Pa., Jan. 16, 2013 /PRNewswire/ -- ViroPharma Incorporated (VPHM) today announced the publication of data demonstrating that use of Cinryze (C1 esterase inhibitor [human]) in pediatric patients provided relief from symptoms of hereditary angioedema (HAE) attacks and reduced the rate of attacks. HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of a human plasma protein called C1 inhibitor. The paper entitled Nanofiltered C1-Esterase Inhibitor for The Acute Management and Prevention of Hereditary Angioedema Attacks Due to C1-Inhibitor Deficiency in Children by Dr. William Lumry et al. describes the efficacy and the safety profile of Cinryze in prevention and treatment of HAE attacks in the largest analysis of pediatric data from prospective studies of patients with HAE ever reported in medical literature. The article is in press at The Journal of Pediatrics and was posted online on January 14, 2013. Cinryze is approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE; Cinryze is not approved to treat HAE attacks or for procedural prophylaxis. Cinryze is not approved for use in children. According to published literature, in most patients with HAE, clinical symptoms … Continue reading →

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Menopause Matters: Questions You May Be Asking Yousrelf – Video

Posted: Published on January 17th, 2013

Menopause Matters: Questions You May Be Asking Yousrelf Gynaecologist, Dr Heather Currie talks about various aspects of Menopause: What is Hormone Replacement Therapy, Is there a link between breast cancer and HRT,can Menopause effect your sex life and more... By: Askimo T.V … Continue reading →

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Hormone Replacement Scottsdale | Preparing Injection Dose | LifeXMD – Video

Posted: Published on January 17th, 2013

Hormone Replacement Scottsdale | Preparing Injection Dose | LifeXMD http://www.lifexmd.com Hormone Replacement using bioidentical hormone replacement therapy for LifeXMD in Scottsdale, Arizona. Nurse Roxy gives instructions on how to properly prepare the dose for injection. LifeXMD is a physician supervised bioidentical hormone replacement therapy clinic for men and women seeking more energy, increased libido, decreased fat deposits, and better sleep. Testosterone estrogen replacement are some of the many benefits that LifeXMD can provide. Steps for preparing an injection dose: 1. Take The Cap Off The Vial, Then, Clean The Rubber Stopper With An Alcohol Swab. 2. Inspect Syringe Packaging For Damage Or Tampering. If Damage Has Occurred, Dispose of the Syringe. If No Damage, Carefully Remove The Syringe From The Package. 3. Remove The Needle Cover From The Syringe. Then, Gently Pull Back On The Plunger To Draw Air Into The Syringe. The Amount Of Air In The Syringe Should Be Equal To Your Physician Prescribed Dose. 4. Place The Vial On A Flat Working Surface And Insert The Needle Through The Rubber Stopper., DO NOT Insert The Needle More Than One Time. 5. Push The Plunger Of The Syringe Down, Until You Have Injected All Of The Air From … Continue reading →

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Should You Take Testosterone? How to Know if its Right for You (Testosterone Replacement Therapy) – Video

Posted: Published on January 17th, 2013

Should You Take Testosterone? How to Know if its Right for You (Testosterone Replacement Therapy) Please SHARE THIS VIDEO if you found it useful or if you know somebody who is suffering and/or feeling alone. Thank you. MY STORY My name is Noah and on May 18 2011, I had a rare reaction to a vaccine called VIVITROL and consequently spiraled into a major, agitated, suicidal depression with depersonalization. I lost 25 lbs in 4 weeks and was in full panic or near panic for 8 weeks straight mixed with the darkest most painful depression I cold have ever imagined. I immediately could not work and had to move in with my parents who along with many siblings and friends had to watch me 24/7 as I was so suicidal. I was eventually hospitalized. Getting through each day seemed truly unbearable and I knew I would surely die. I have been put on many many different SSRI's SNRI's Tricyclics, Mood stabilizers, anti psychotics, holistic meds, acupuncture and even a form of shock therapy called RTMS. I barely saw any improvement in my condition for a full year. It was decided I had treatment resistant depression and I spent … Continue reading →

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Dr. Georgia Purdom with Answers in Genesis will discuss stem-cell research – Video

Posted: Published on January 17th, 2013

Dr. Georgia Purdom with Answers in Genesis will discuss stem-cell research By: Jeff Reed … Continue reading →

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Katie M Stem Cell Research Infomercial – Video

Posted: Published on January 17th, 2013

Katie M Stem Cell Research Infomercial Infomercial for AP Lang By: skatepunk23ify … Continue reading →

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MHC-TV interview with heart surgeon Dr. Mark Zucker – Video

Posted: Published on January 17th, 2013

MHC-TV interview with heart surgeon Dr. Mark Zucker Dr. Joseph Clemente, host of MHC-TV, interviews Mark J. Zucker, MD, JD, Director, Heart Failure Treatment and Transplant Program at Newark Beth Isreal Medical Center . They discuss getting a heart transplant, other treatments such as the Left Ventricular Assist Device (LVAD), and about stem cell research ongoing today. By: medicalhealthTV … Continue reading →

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