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Biogen Idec Submits Application to FDA for Approval of Oral BG-12 to Treat Multiple Sclerosis

Posted: Published on February 28th, 2012

- EMA Submission Anticipated within the Coming Days - WESTON, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The regulatory submission was based on BG-12’s comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies. “While there have been important therapeutic advances in MS over the last 15 years, there is still a significant unmet need for new and innovative therapies that target the disease in different ways” “While there have been important therapeutic advances in MS over the last 15 years, there is still a significant unmet need for new and innovative therapies that target the disease in different ways,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “Based on the robust clinical efficacy and safety data seen in our Phase 3 studies, we believe BG-12 has the potential to become an important oral treatment option for MS patients.” Biogen Idec … Continue reading

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Tim Cook hikes the Appalachian Trail for MS

Posted: Published on February 28th, 2012

The Appalachian Trail is 2200 miles of raw nature. It passes through 14 states. At times a treacherous terrain that starts in Georgia and ends in Maine. It will take Tim Cook six months to walk its entire path.   But this is a journey to find a cure for the only person who really understands why he is doing it. "Cathy and I met when we were down in Bernie, Texas, just outside of San Antonio.   In fact we were the only two people above the age of sixteen and under the age of eighty that were single so," Tim remembers.  They've been together ever since.   If you've ever met the cooks you know you've just experienced something special.  A bond they've leaned on for the last two years.  That's because two years ago when Cathy lost sight in one of her eyes, she was diagnosed with Relapsing Remitting Multiple Sclerosis.   April Brownlee with the National Multiple Sclerosis Society explains what MS. is, ". . .the coating on your nerves is called Myelin it wears away for whatever reason the body eats away at that coating, and it basically causes your body to short circuit." SOT Cathy recalls how she … Continue reading

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FDA Approves AVONEX® PEN™ and Dose Titration Regimen

Posted: Published on February 28th, 2012

WESTON, Mass.--(BUSINESS WIRE)-- Today Biogen Idec (NASDAQ: BIIB - News) announced that the U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS). AVONEX PEN, the first intramuscular (IM) autoinjector approved for MS, incorporates a smaller needle and easier administration to help patients reduce anxiety about AVONEX self-injection. A new dose titration regimen, which gradually escalates the dose of AVONEX at treatment initiation, reduces the incidence and severity of flu-like symptoms that can occur at the beginning of therapy. “AVONEX has been an effective treatment for MS for more than 15 years, and data have shown it to have the highest adherence rate among currently marketed injectable therapies,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “However, anxiety around administration and the potential for flu-like symptoms can be a barrier for some patients. AVONEX PEN and the new titration regimen reflect our commitment to enhancing the Biogen Idec products that people with MS rely on today.” AVONEX PEN (AVONEX 30mcg/0.5mL solution for injection) is an automated injection device designed to be easier to use … Continue reading

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Biogen Idec submits FDA application for promising MS drug

Posted: Published on February 28th, 2012

By Chris Reidy, Globe Staff Biogen Idec Inc., a Weston-based biotechnology company known for its multiple sclerosis drugs, said it has submitted a New Drug Application to federal regulators to get approval to market a potential new MS treatment known as BG-12. In December, Biogen Idec shares hit their high for 2011 after the company released promising results from a clinical trial of BG-12. BG-12, the company’s designation for dimethyl fumarate, would be taken twice a day in pill form, and it is designed to treat of relapsing-remitting multiple sclerosis, sometimes called RRMS, the most common form of MS, Biogen Idec said in a press release. Two other Biogen Idec MS drugs are delivered differently. Tysabri is administered in a once-a-month infusion, and Avonex is injected once a week, the company said. Biogen Idec, which said today that it had submitted a New Drug Application to the US Food and Drug Administration, added that it plans to submit a similar request to European regulators within the next few days. Biogen Idec said it anticipates hearing from regulatory authorities regarding the status and acceptance of its BG-12 submissions “within the next couple of months.” In a separate press release this morning, … Continue reading

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Stem Cell Research Could Allow Women Post-Menopause Babies

Posted: Published on February 28th, 2012

A long-held belief about women and fertility is that each woman has a set amount of eggs in her lifetime and that when those eggs are depleted at menopause, so are her chances at having a biological child. However, research out of Massachusetts General Hospital is questioning that view. Using stem cells taken from human ovaries, scientists have produced early-stage eggs, which brings up all sorts of questions about possible new methods for treating infertility. Nicholas Wade, writing in The New York Times, adds, "The ability to isolate stem cells from which eggs could be cultivated would help not only with fertility but also with biologists' understanding of how drugs and nutrition affect the egg cells." Jonathan Tilly, the director of Mass General's Vincent Center for Reproductive Biology and leader of the new research, had reported in 2004 that ovarian stem cells in mice could create new eggs "similar to how stem cells in male testes produce sperm throughout a man's life." His new study attempted to prove this with humans. Researchers took healthy ovaries from patients having sex reassignment surgery, and injected stem cells from the ovaries into human ovarian tissue grafted under the skin of mice: "Within two weeks, early … Continue reading

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Stem Cell Pioneers Converge in Portland to Discuss and Celebrate a Revolutionary New Stem Cell Entering Human Clinical …

Posted: Published on February 28th, 2012

SAN DIEGO, CA and PORTLAND, OR--(Marketwire -02/28/12)- Medistem Inc. (Pinksheets: MEDS.PK - News) announced today its Annual "Evening with Medistem" Event will take place in Portland, Oregon on March 7th, 2012. The event is being hosted by Vladimir Zaharchook, Vice Chairman at Medistem, Inc., and will feature stem cell luminaries and pioneers working with Medistem including Dr. Amit Patel, Director of Regenerative Medicine at University of Utah and the first person to administer stem cells into patients with heart failure, Dr. Michael Murphy, Vascular Surgeon at Indiana University and Principal Investigator for Medistem's FDA clinical trial in patients with risk of amputation, and Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, advisory board member of Medistem. In 2007 Medistem discovered an entirely new type of stem cell, the Endometrial Regenerative Cell (ERC). This cell has proven it is a "universal donor" and can be used to treat many more conditions compared to other types of stem cells. The company received FDA clearance to begin clinical trials in September of 2011 for critical limb ischemia, a condition that is associated with amputation. Medistem is also running a Phase II clinical trial for heart failure using the new stem … Continue reading

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Global Genetic Testing Market to Reach US$2.2 Billion by 2017, According to New Report by Global Industry Analysts, Inc.

Posted: Published on February 28th, 2012

GIA announces the release of a comprehensive global report on the Genetic Testing market. The global market for Genetic Testing is forecast to reach US$2.2 billion by 2017. Increasing knowledge about the potential benefits in genetic testing is one of the prime reasons for the growth of the genetic testing market. Advancements in the genetic testing space, aging population and a subsequent rise in the number of chronic diseases, and increasing incidence of cancer cases are the other factors propelling growth in the genetic testing market. San Jose, California (PRWEB) February 28, 2012 Follow us on LinkedIn – Genetic testing represents the most rapidly expanding segment of the molecular diagnostics market worldwide. Growing incidence of genetic diseases unravels new opportunities for genetic testing. The transformation of genetic testing from being a service-driven market to a product-driven market is expected to provide an impetus to the diagnostic companies for the expansion of their operations. The market for screening the newborns, diagnosing rare and fatal disorders, and predicting the probability of occurrence of diseases is likely to expand. Particularly, genetic tests to screen the newborns are expected to expand immensely over the coming years. The US represents the largest market for genetic … Continue reading

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Laboratories Essential to Success of Personalised Medicine, but Often Forgotten by Pharmaceutical Industry, According …

Posted: Published on February 28th, 2012

LONDON--(Marketwire -02/28/12)- Laboratories performing molecular or genetic diagnostic testing play a vital strategic role in the success of personalized medicine (PM), but are often the "forgotten" link, according to a new survey of 31 laboratories in five EU countries conducted by Labceutics, a division of Diaceutics, that provides value-enhancing laboratory networks and services for the PM industry. "We wanted to better understand the barriers faced by laboratory leaders as they seek to partner with pharmaceutical companies in the development of companion diagnostic tests for PM," said Maria Fe Paz, Managing Director of Labceutics. "Laboratories' interest in early participation has important implications for the success of pharmaceutical companies' PM businesses." Survey findings included: Laboratories as PM stakeholders have been largely forgotten by pharmaceutical companies, which wrongly assume that diagnostic partners have sufficiently engaged laboratories; Unlike the US, Europe has a fragmented laboratory market with strong country personalities, therefore centralized approaches may be too disruptive; A decentralised laboratory strategy in Europe will enable a "high touch" service among laboratory managers or pathologists and physicians; One-size-fits-all laboratory testing plans or "kit" approaches will encounter slow uptake in Europe; Successful introduction of PM therapeutics and companion diagnostics must include early preplanning with laboratories. "Labs … Continue reading

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

Posted: Published on February 28th, 2012

DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI). Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions. “The prospect of using a person’s own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach,” said Norbert Riedel, Ph.D., Baxter’s chief science and innovation officer. “The goals of this phase III trial are aligned with Baxter’s overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.” The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three … Continue reading

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Georgia Research Alliance Names First Eminent Scholar in Nanomedicine

Posted: Published on February 28th, 2012

ATLANTA--(BUSINESS WIRE)-- Younan Xia, Ph.D., an internationally recognized leader in the field of nanotechnology, recently joined the Georgia Institute of Technology as the first Georgia Research Alliance (GRA) Eminent Scholar in Nanomedicine. Dr. Xia is the Brock Family Chair and GRA Eminent Scholar in Nanomedicine in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, with a joint appointment in the School of Chemistry and Biochemistry. His research focuses on nanocrystals -- a novel class of materials with features smaller than 100 nanometers -- as well as the development of innovative technologies enabled by nanocrystals. One nanometer is equal to one billionth of a meter. These technologies span the fields of molecular imaging, early cancer diagnosis, targeted drug delivery, biomaterials, regenerative medicine and catalysis. “The possible applications of nanotechnology in medicine have only begun to be explored,” said Michael Cassidy, president and CEO of the Georgia Research Alliance. “Dr. Xia’s expertise and collaborative vision will lead to vital new scientific discoveries that can be transformed into new tools to help people live healthier lives.” Dr. Xia is an international leader in the synthesis of nanomaterials designed to improve the way we live. He has been … Continue reading

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