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Biogen Rises on Optimism MS Pill May Get EU Protection

Posted: Published on June 28th, 2013

Biogen Idec Inc. (BIIB), the worlds biggest maker of multiple sclerosis drugs, surged the most in 20 months on investor optimism that the companys Tecfidera pill may gain protection from generic-drug competition in Europe. Biogen climbed 4.8 percent to $218.85 at 12:59 p.m. New York time, after increasing 16 percent in its biggest intraday gain since October 2011. European regulators may rule later this year on whether to approve Tecfidera, already cleared in the U.S., the Weston, Massachusetts-based company said in May. The European Medicines Agencys Committee for Medicinal Products for Human Use today granted new active substance status to Sanofis MS treatment Aubagio, which protects the medicine from generic competition for 10 years. The ruling may help Biogen gain protection for Tecfidera as well, said Brian Abrahams, an analyst at Wells Fargo & Co. in New York. The Sanofi ruling shows the European regulator is open to a sponsors arguments that a new drug should merit some regulatory exclusivity, Abrahams said in a note. We see this as an indirect, incremental positive. Tecfidera was approved in the U.S. in March. Biogen has asked the European regulator for exclusivity under a process referred to as the independent development principle, Abrahams … Continue reading

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European advisory panel issues positive opinions on two MS drugs from Genzyme

Posted: Published on June 28th, 2013

Genzyme, a Cambridge-based unit of the French drugmaker Sanofi SA, said that it has moved closer to getting approvals to marketing two multiple sclerosis drugs in Europe. The drugs are Lemtrada, a treatment for adult patients with relapsing multiple sclerosis, and Aubagio, also an MS treatment. In a press release, Genzyme said that the Committee for Medicinal Products for Human Use, or CHMP, has issued a positive opinion on the approvals of Lemtrada and Aubagio. In deciding on whether to grant marketing approval for a drug candidate, regulators on the European Commission often follows the recommendations of the CHMP panel. As a result of the CHMPs positive opinions, Genzyme said it expects Lemtrada and Aubagio to get European marketing approvals in the coming months. Genzyme has long been known as a maker of treatments for rare diseases. With the support of Sanofi --- Sanofi bought Genzyme for $20.1 billion in 2010 --- Genzyme is looking to enter the lucrative, and broader, market for multiple sclerosis drugs. The market for such drugs has been estimated at about $13 billion a year worldwide. Genzyme has also been seeking approval to market Lemtrada in the US. Last August, Genzyme suffered a setback when … Continue reading

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European regulators back Sanofi’s injectable MS treatment, reverse MS pill decision

Posted: Published on June 28th, 2013

LONDON (Reuters) - Sanofi's hopes in the multiple sclerosis market received a double boost on Friday as the European regulator backed an injectable treatment and adopted a more positive stance toward a pill for the neurodegenerative disease. The European Medicines Agency said it was recommending Lemtrada, Sanofi's biggest MS drug hope, for relapsing-remitting MS, ending a quarter-century development saga for the injectable treatment. The European regulator also reversed an earlier decision not to give pill-administered Aubagio a "new active substance" (NAS) designation because it is very similar to a much older drug. Without this designation, Aubagio, which received the regulator's green light in March, could have faced generic copies in Europe in as little as three years - the time required for brief clinical studies of generics and to review applications for approval. The news sent the stock over 1 percent higher. Sanofi's shares, which have risen around 13 percent since the start of 2013, were trading 0.8 percent higher at 80.65 euros at 1225 GMT, outperforming Paris' CAC40 bluechip index, down 0.7 percent. LENGHTY DEVELOPMENT EMA decisions are usually endorsed by the European Commission within a couple of months. The U.S. Food and Drug Administration is expected to rule … Continue reading

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"Bio Identical" Testosterone FACTS – Video

Posted: Published on June 28th, 2013

"Bio Identical" Testosterone FACTS More vids, articles, blog, and FREE reports: http://www.brinkzone.com/ "Bio Identical" hormones are being marketed strongly as a safer alternative to other f... By: Will Brink … Continue reading

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Study examines HRT impact on females’ memory – Video

Posted: Published on June 28th, 2013

Study examines HRT impact on females' memory A new study is adding to the debate on hormone replacement therapy for post-menopausal women. Dr. Sue Decotiis, a hormone replacement specialist at New York ... By: CBSNewsOnline … Continue reading

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World’s Youngest Transsexual – Kim Petras – Video

Posted: Published on June 28th, 2013

World's Youngest Transsexual - Kim Petras German teenager Kim Petras who became the world's youngest transsexual after undergoing an operation at the age of just 16 says she can't wait for the summer... By: LandonProduction … Continue reading

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HRT provides no brain benefits for young menopausal women, new study finds

Posted: Published on June 28th, 2013

Taking hormone replacement therapy soon after menopause starts wont protect against memory problems or other signs of cognitive decline that occurs with aging, according to a new analysis of a landmark clinical trial published online Monday in the journal JAMA Internal Medicine. It also, though, wont harm brain function in middle-aged women who take hormone therapy to relieve menopausal hot flashes, night sweats, and mood swings. Thats reassuring news to those seeking menopausal symptom relief from hormone therapy but may also be worried about previous research showing that hormones speed cognitive decline and increase the risk of dementia in elderly women. Researchers from the Brigham and Womens Hospital and elsewhere relied on data from more than 1300 female participants, ages 50 to 55, who were randomly assigned to take HRT for an average of seven years as part of the Womens Health Initiative clinical trial. Cognitive testingperformed about seven years after the trial endedfound no differences in memory, problem-solving, or learning skills in those who took hormone therapy and those who took placebos. What the latest analysis didnt address is whether taking hormones right at the onset of menopausewhen symptoms occur-- have any benefits or risks in terms of cognitive … Continue reading

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Hormone therapy doesn’t impact brain function when used in early stages of menopause

Posted: Published on June 28th, 2013

NEW YORK (Reuters Health) - Hormone replacement therapy during the early stages of menopause - typically around age 50 - doesn't hurt or help brain function, according to a new study. Researchers found that women between the ages of 50 and 55 years old who took estrogen or estrogen with progesterone performed just as well on tests that measure memory problems as women of the same age who took a placebo. "Our findings are that we didn't see any long term impact on cognitive function," said Mark Espeland, the study's lead author, from the Wake Forest School of Medicine in Winston-Salem, North Carolina. Previous studies had found that women 65 years old and older suffered lasting memory problems when they used hormone therapy to treat symptoms of menopause, such as hot flashes, vaginal dryness and trouble sleeping. Imaging tests even found that the brains of those older women assigned to hormone therapy had become smaller, compared to those who took a placebo. Currently, the government-backed U.S. Preventive Services Task Force recommends that postmenopausal women avoid hormone replacement therapy due to increased risks of heart disease, stroke, breast cancer and dementia. Some research, however, has suggested there may be a "window … Continue reading

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Women on Hormone Therapy May Benefit From Extra Calcium, Vitamin D

Posted: Published on June 28th, 2013

By Serena Gordon HealthDay Reporter WEDNESDAY, June 26 (HealthDay News) -- Although there has been significant debate about whether calcium and vitamin D supplements are beneficial for older women, new research suggests that the answer may be yes for those who are taking hormone replacement therapy. Women using HRT who also took daily supplements of calcium and vitamin D saw a 40 percent reduction in their rate of hip fractures compared to women who took placebo supplements, according to the study. "We found that women who were on hormones had less hip fractures, and women who were on hormones and calcium and vitamin D supplements had even fewer hip fractures," said study author Dr. John Robbins, a professor of medicine at the University of California at Davis. Results of the study were published online June 26 in the journal Menopause. As many as half of all women over 50 will have an osteoporosis-related fracture in their lifetime, according to the U.S. Preventive Services Task Force (USPSTF). Osteoporosis is a condition caused by a loss of bone mass and density, which leaves bones fragile and more susceptible to fractures. Calcium is an important component in bone growth, and vitamin D helps … Continue reading

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Women reconsidering hormone replacement therapy

Posted: Published on June 28th, 2013

MIAMI - Although many women are frightened by concerns of a potential link between hormone replacement therapy and cancer or heart disease, some are re-evaluating that risk in the light of new conclusions. Maria Venereo said she was hesitant to undergo hormone replacement therapy at first. "I heard a lot of stories and reading about it and all that, I said, yeah, I'll put it off, I'll put it off," she said. "[I] try a few things, natural stuff, didn't work." Venereo turned to Cooper City midwife Karen Bosia for guidance and found reassurance. "I personally take estrogen every day, and I've been taking it for 12 years and I don't plan on stopping it," said Bosia. Bosia said the conventional belief that hormone replacement therapy is dangerous is based on research done over a decade ago using synthetic hormones. "The synthetics are, you know, chemically produced and they're not exactly the same as what your body produces," she added. Bosia and many other doctors now use individually compounded bio-identical hormones. "A bio-identical is taken from the yam plant and it's structured -- if you look at the hydrogens and the oxygens -- it's structured exactly like the estradiol and … Continue reading

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