- Jean-Jacques Garaud, Global Head of Roche Pharma Research and Early Development, said: “This acquisition augments our already strong HCV portfolio. Our aim is to offer physicians and hepatitis patients a powerful combination of therapies that bring us closer to a cure, even without the use of interferon. Anadys’ compounds provide additional modes of action that could lead to interferon-free treatment regimens without viral resistance.”
- Steve Worland, President and Chief Executive Officer of Anadys, said: “Since Anadys was founded, our focus has been on driving forward research that would make a real difference to the lives of patients, especially those with hepatitis. With Roche’s considerable capabilities and experience in HCV, this acquisition provides the best chance of success for the new potential treatments our team has been dedicated to developing.”
NPI Registry, International Classification of Diseases,ICD,HCPCS, , CPT, National Drug Codes,NDC, SNOMED CT, MEDCIN, Medical news, Health news, Healthcare news, General welfare, and healthy living will bring forth a healthy society. This site is not intended to provide medical advice, diagnosis or treatment. Disclosure; This site shows ads compensated for them.
Monday, October 17, 2011
Roche Will Acquire Anadys For $230 Million.
Wednesday, October 05, 2011
Oral Teriflunomide for Relapsing Multiple Sclerosis Treatment
The trial was funded by Sanofi-Aventis; TEMSO ClinicalTrials.gov number, NCT00134563
Sanofi-Aventis Press Release;
Findings from Two-Year Pivotal Phase III TEMSO Trial Published today in The New England Journal of Medicine -
PARIS, Oct. 5, 2011 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today the publication of the pivotal Phase III TEMSO study with investigational once-daily oral medication teriflunomide in The New England Journal of Medicine (NEJM). Results showed that teriflunomide at the 14mg dosage significantly reduced the annual relapse rate, reduced disability progressions and improved several magnetic resonance imaging (MRI) measures of disease activity, including new or worsening brain lesions. Teriflunomide has a well-characterized safety profile, with a similar proportion of trial participants reporting adverse events compared to placebo.
"The TEMSO data demonstrate the effect of teriflunomide in terms of reducing relapse rates, disability progression and Magnetic Resonance Imaging (MRI) lesions," said Dr. Paul O'Connor, Director of the MS Clinic at St Michael's Hospital, Toronto, Canada and principal investigator in the TEMSO study. "These results, sustained over two years, provide clinically meaningful data for teriflunomide."
The two-year TEMSO (TEriflunomide Multiple Sclerosis Oral) trial involved 1,088 people with relapsing forms of MS from 126 centers across 21 countries. TEMSO is the first study from a broad clinical development program that includes more than 4,000 trial participants in 36 countries and is one of the largest and broadest clinical programs of any oral MS agent under development, with five Phase III clinical trials either completed or underway.
"The publication of the teriflunomide results in the New England Journal of Medicine is an exciting milestone as we continue the development of our product," said Dr. Elias Zerhouni, President, Global Research & Development, Sanofi. "As we continue our commitment to research, innovation and the Multiple Sclerosis community, we look forward to providing therapeutic options for patients across the Multiple Sclerosis spectrum."
Teriflunomide has been filed with the FDA in August of 2011 and the EMA filing is expected in the first quarter of 2012. The results from the TEMSO study are and will be included in each regulatory submission.
TEMSO findings showed that, compared to placebo, teriflunomide once daily:
Significantly reduced the risk of annual relapses, the primary endpoint, by 31% (both p<0.001) for 7mg and 14mg doses.
Significantly increased the time to first relapse, and allowed significantly more trial participants to remain free of relapses during the two years of the study: 53.7% (7mg, p=0.01 vs. placebo), 56.5% (14mg, p=0.003 vs. placebo) and 45.6% (placebo).
The risk of 12-week confirmed disability progression, the key secondary endpoint, was significantly reduced by 30% (p=0.03) for the 14mg dose and numerically reduced by 24% (p=0.08) for the 7mg dose.
Improved several standard magnetic resonance imaging (MRI) measures of disease activity as compared to placebo including new or worsening brain lesions with an apparent dose dependent effect in favor of the 14mg dose:
Reduced burden of disease (by 39.4% [p=0.03] and 67.4% [p<0.001] for 7mg and 14mg, respectively);
Reduced gadolinium-enhancing T1 lesions (relative risk reduction of 57% and 80%, p<0.001 for both doses);
Reduced unique active lesions per scan (relative risk reduction of 48% and 69%, p<0.001 for both doses).
Similar adverse events, serious adverse events, and adverse events leading to treatment discontinuation were observed with teriflunomide compared to placebo. No serious or opportunistic infections and no deaths occurred in trial participants treated with teriflunomide. The proportion of participants who discontinued the study medication because of disease progression was significantly smaller in the group receiving the 14mg of teriflunomide than in the placebo group (p=0.02). Malignancies were reported in three participants in the placebo group and one in the teriflunomide 14mg group.
Teriflunomide adverse events were usually of mild to moderate intensity, managed with existing therapies and rarely led to treatment discontinuation. The most common were diarrhea, nausea, liver enzyme increases (that were mainly mild and asymptomatic with no dose effect) and mild hair thinning/decreased hair density. In general, diarrhea, nausea and alopecia, were mild to moderate, transient, and infrequently led to treatment discontinuation.
About Teriflunomide
Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of MS. Teriflunomide blocks the proliferation and functioning of activated T and B lymphocytes - which are thought to be especially damaging in MS - by selectively and reversibly inhibiting a critical mitochondrial enzyme. Slowly dividing or resting lymphocytes are unaffected by teriflunomide, leaving the immune system's response to infection uncompromised. With nine years of continuous use in a Phase II extension, teriflunomide has the longest clinical experience of any investigational oral MS therapy. In addition to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are ongoing in people with RMS. A Phase III study, TOPIC, is also underway in early MS or CIS (clinically isolated syndrome). Teriflunomide is also being evaluated as an adjunct therapy to interferon-beta in the Phase III TERACLES trial.
(*) Aubagio™ is the registered name submitted to health authorities for the investigational agent teriflunomide.
About Multiple Sclerosis
Today more than 2,000,000 people around the world suffer from MS, a chronic autoimmune disease that affects the central nervous system - the brain, spinal cord and optic nerves. In MS, immune cells called lymphocytes mistakenly attack myelin, the fatty "insulation" that surrounds and protects nerves, resulting in abnormal nerve transmission and MS symptoms such as fatigue, weakness, walking and balance problems, vision problems, pain, spasticity and cognitive difficulties. MS is the most common disabling neurological disease in young adults after accidents, and is two to three times more common in women than in men. MS is usually characterized by relapses followed by periods of complete or incomplete recovery. There is no typical individual with MS, as the disease is a very variable condition and the symptoms depend on which areas of the central nervous system are affected. MS symptoms can vary from time to time and can change in severity and duration, even in the same person. The vast majority of people with MS - approximately 90 percent - are initially diagnosed with a relapsing form of MS.
Magnetic resonance imaging (MRI) is a common and important tool used to help establish a diagnosis of MS and monitor the course of the disease and effects of treatment. Providing a highly sensitive, non-invasive way to image the brain, spinal cord or, other areas of the body, MRI has made it possible to visualize and understand a great deal about the underlying pathology of MS.
About Genzyme, a Sanofi Company
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.
Genzyme's Multiple Sclerosis business unit is responsible for the development of teriflunomide, along with the investigational MS therapy alemtuzumab.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
FDA Releases A Report On Driving Biomedical Innovation
FDA released “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.”a new report today, The report outlines “immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans."
The blueprint focuses on implementing the following major actions:
• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.
It is very timely and we are in need of it.
FDA released a report containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans. The report addresses concerns about the medical product development pipeline, one of the most pressing challenges facing the biomedical industries.
Release of the report, kicks off a new FDA-wide Innovation Initiative, which promises to redouble the agency’s efforts to encourage innovations that will promote public health as well as strengthen the American economy.
We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.
Printer Friendly PDF (6.3MB)
Press Release: FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans
Fact Sheet
Relieve Stress By Being Mindful!
So usual reaction is to tune out to relieve the stress but big doctor from Harvard, Michael Craig Miller, M.D., Editor in Chief, Harvard Mental Health Letter says may be not too fast.
According to an article he published, being mindful may be the answer to make stress not stick.
"The practice of mindfulness, which has its roots in Buddhism, teaches people to be present in each moment. The idea is to focus attention on what is happening now and accepting it without judgment.Although it sounds simple, and even simplistic, mindfulness is a powerful therapeutic tool. It has been shown to ease stress, prevent major depression from reappearing, alleviate anxiety, and even reduce physical symptoms such as pain or hot flashes. As my colleague Carolyn Schatz wrote on this blog a few months back, one way mindfulness works its magic is by improving connections in the brain."He also gives some tips on being mindful;
"you can do this on your own by practicing a few simple techniques, like sitting quietly, focusing on your breathing, becoming aware of your surroundings, and watching what comes and goes in your mind."If the article interested you at all, then there is more complete information on being mindful, "Mind over Matter" article in the October 2011 Harvard Mental Health Letter
http://www.health.harvard.edu/newsletters/Harvard_Mental_Health_Letter/2011/October/mind-over-matter
Friday, September 30, 2011
Primatene Mist, Epinephrine Inhalers For Asthma, Will No Longer Be Available After Dec. 31, 2011

chlorofluorocarbons, or CFCs — the ozone-depleting chemicals that were banned in the late '70s have quietly existed in Asthma inhalers. Even though they were banned in use, CFCs were permitted in medical products such as asthma inhalers which was deemed essential.
But that is also coming to an end as the FDA recently announced that phasing out of asthma inhalers that use CFCs. Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. Primatene Mist is also the only Asthma inhaler available over the counter.
With all these in mind, users of Primatene Mist must take appropriate action to replace the medicine in timely manner. They will have to use a prescription medicine to replace Primatene Mist. Due to the demand, Primatene Mist may even be harder to find even before the deadline, follow the links given below to find the best solution.
For more information:
• Phase Out of Epinephrine CFC Metered-Dose Inhalers
• Epinephrine CFC Metered-dose Inhalers - Questions and Answers
• Consumer Update: Primatene Mist with Chlorofluorocarbons No Longer Available After Dec. 31, 2011
FDA Announcement;FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011
Users of Primatene Mist will need a prescription product to treat their asthmaThe U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.
Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold over-the-counter in retail stores without a prescription. The product uses CFCs to propel the medicine out of the inhaler so that consumers can breathe it into their lungs.
However, Primatene Mist will no longer be available by year’s end because no CFC-containing epinephrine inhalers can be made or sold after Dec. 31, 2011, to comply with obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. This is an international agreement signed by the United States, in which countries agreed to phase-out substances that deplete the ozone layer, including CFCs, after certain dates.
“If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA began public discussions about the use of CFCs in epinephrine inhalers in January 2006. The FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008. Many manufacturers have changed their inhalers to replace CFCs with an environmentally-friendly propellant called hydrofluoroalkane (HFA). There is currently no HFA version of epinephrine inhalers.
There are, however, many other safe and effective inhalers to treat asthma symptoms. All of these inhalers require a prescription, which must come from a licensed health care professional (physician, physician’s assistant or nurse practitioner). Current epinephrine inhaler users that don’t have a health care professional to write them a new prescription can ask a family member or friend what doctor they use and would recommend, or they can visit a federally-qualified health center, local clinic, community health center, or minute-clinic (sometimes located in pharmacies) to see a health care professional and get a prescription.
Primatene Mist already carries a prominent notice about the phase-out date on its product label, and the FDA encourages Armstrong Pharmaceutical to further educate consumers as the deadline approaches to ensure an incident-free transition. The agency also will continue to work with retailers and pharmacies to facilitate a smooth phase-out of this CFC product and is prepared to review applications for replacement products.
For more information:
• Phase Out of Epinephrine CFC Metered-Dose Inhalers
• Epinephrine CFC Metered-dose Inhalers - Questions and Answers
• Consumer Update: Primatene Mist with Chlorofluorocarbons No Longer Available After Dec. 31, 2011
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Thursday, September 15, 2011
Apixaban May Join Wafarin Combatting Clot For Patients With Atrial Fibrillation.
The trial was to find if Apixaban was non inferior to Wafarin but the trail investigators found that apixaban was actually superior, reducing the risk of stroke or systemic embolism by 21% and the risk of major bleeding by 31%. In predefined hierarchical testing, apixaban, as compared with warfarin, also reduced the risk of death from any cause by 11%.
The Apixaban results follow two other, phase 3 trials that compared new anticoagulants with warfarin in patients with atrial fibrillation:
the Randomized Evaluation of Long-Term Anticoagulation Therapy trial (RE-LY, NCT00262600)(Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-1151[Erratum, N Engl J Med 2010;363:1877.]
Full Text | Medline ) and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF, NCT00403767)- (Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-891 Full Text | Medline ). The RE-LY trial evaluated the direct thrombin inhibitor dabigatran in two different doses, 110 mg and 150 mg, both administered twice daily. ROCKET AF evaluated the direct factor Xa inhibitor rivaroxaban at a dose of 20 mg once daily.
The trials have a number of similar conclusions. Apixaban, dabigatran, and rivaroxaban, as compared with warfarin, all significantly reduce the risk of hemorrhagic stroke. In fact, in all the studies, the reductions in the primary efficacy end point — which included hemorrhagic as well as ischemic stroke — were greatly influenced by this dramatic reduction in the risk of hemorrhagic stroke. Of the three drugs, only dabigatran at a dose of 150 mg holds the distinction of also having significantly reduced the risk of ischemic stroke as compared with warfarin; nonetheless, even in this case, there was a greater influence on hemorrhagic stroke than on ischemic cerebrovascular events. Similarly, the risk of particularly serious bleeding was reduced with each of the three drugs, as compared with warfarin, and apixaban therapy also resulted in lower rates of all major bleeding. Thus, the newer anticoagulants boast favorable bleeding profiles as compared with warfarin in patients with atrial fibrillation.NEJM
Monday, September 12, 2011
IBM's Jeopardy Wiz Watson Goes To Work For WellPoint, A Medical Insurance Company
The Wall Street Journal reports that IBM's new technology will first be put to use for patient treatment requests by quickly scanning a person's medical history and suggesting the best course of action. In the coming years, Wellpoint hopes to put Watson's immense database at the fingertips of doctors and nurses, providing a valuable ally in disease diagnosis and research.
WellPoint and IBM Announce Agreement to Put Watson to Work in Health Care
INDIANAPOLIS and ARMONK, N.Y., Sept. 12, 2011 /PRNewswire via COMTEX/ -- WellPoint, Inc. (NYSE: WLP), and IBM (NYSE: IBM) announced an agreement today to create the first commercial applications of the IBM Watson technology. Under the agreement, WellPoint will develop and launch Watson-based solutions to help improve patient care through the delivery of up-to-date, evidence-based health care for millions of Americans. IBM will develop the base Watson healthcare technology on which WellPoint's solution will run.
Watson, named after IBM founder Thomas J. Watson, is a computing system built by a team of IBM scientists who set out to accomplish a grand challenge - build a computing system that rivals a human's ability to answer questions posed in natural language with speed, accuracy and confidence. Earlier this year, Watson competed and won against two of the most celebrated players ever to appear on Jeopardy!. This historic match is being rebroadcast over three days, beginning today.
Watson's ability to analyze the meaning and context of human language, and quickly process vast amounts of information to suggest options targeted to a patient's circumstances, can assist decision makers, such as physicians and nurses, in identifying the most likely diagnosis and treatment options for their patients.
In recent years, few areas have advanced as rapidly as health care. For physicians, incorporating hundreds of thousands of articles into practice and applying them to patient care is a significant challenge. Watson can sift through an equivalent of about 1 million books or roughly 200 million pages of data, and analyze this information and provide precise responses in less than three seconds. Using this extraordinary capability WellPoint is expected to enable Watson to allow physicians to easily coordinate medical data programmed into Watson with specified patient factors, to help identify the most likely diagnosis and treatment options in complex cases. Watson is expected to serve as a powerful tool in the physician's decision making process.
Medical conditions such as cancer, diabetes, chronic heart or kidney disease are incredibly intricate. New solutions incorporating Watson are being developed to have the ability to look at massive amounts of medical literature, population health data, and even a patient's health record, in compliance with applicable privacy and security laws, to answer profoundly complex questions. For example, we envision that new applications will allow physicians to use Watson to consult patient medical histories, recent test results, recommended treatment protocols and the latest research findings loaded into Watson to discuss the best and most effective courses of treatment with their patients.
"There are breathtaking advances in medical science and clinical knowledge, however; this clinical information is not always used in the care of patients. Imagine having the ability to take in all the information around a patient's medical care -- symptoms, findings, patient interviews and diagnostic studies. Then, imagine using Watson analytic capabilities to consider all of the prior cases, the state-of-the-art clinical knowledge in the medical literature and clinical best practices to help a physician advance a diagnosis and guide a course of treatment," said Sam Nussbaum, M.D., WellPoint's Chief Medical Officer. "We believe this will be an invaluable resource for our partnering physicians and will dramatically enhance the quality and effectiveness of medical care they deliver to our members."
Watson may help physicians identify treatment options that balance the interactions of various drugs and narrow among a large group of treatment choices, enabling physicians to quickly select the more effective treatment plans for their patients. It is also expected to streamline communication between a patient's physician and their health plan, helping to improve efficiency in clinical review of complex cases. It could even be used to direct patients to the physician in their area with the best success in treating a particular illness.
"With medical information doubling every five years and health care costs increasing, Watson has tremendous potential for applications that improve the efficiency of care and reduce wait times for diagnosis and treatment by enabling clinicians with access to the best clinical data the moment they need it," said Manoj Saxena, general manager, Watson Solutions, IBM Software Group. "WellPoint's commitment to innovation and their work to improve how care is delivered and benefits administered make them an ideal partner for IBM's software and services to pioneer new efficiencies in health care."
Depending on the progress of the development efforts, WellPoint anticipates employing Watson technology in early 2012, working with select physician groups in clinical pilots.
"The implications for health care are extraordinary," said Lori Beer, WellPoint's executive vice president of Enterprise Business Services. "As one of the nation's largest health insurers, we have an important role to play in helping to improve health care quality. We believe new solutions built on the IBM Watson technology will be valuable for our provider partners, and more importantly, give us new tools to help ensure our members are receiving the best possible care."
About WellPoint
WellPoint works to simplify the connection between Health, Care and Value. We help to improve the health of our members and our communities, and provide greater value to our customers and shareholders. WellPoint is the nation's largest health benefits company in terms of medical membership, with 34 million members in its affiliated health plans, and a total of more than 70 million individuals served through its subsidiaries. As an independent licensee of the Blue Cross and Blue Shield Association, WellPoint serves members as the Blue Cross licensee for California; the Blue Cross and Blue Shield licensee for Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri (excluding 30 counties in the Kansas City area), Nevada, New Hampshire, New York (as the Blue Cross Blue Shield licensee in 10 New York City metropolitan and surrounding counties and as the Blue Cross or Blue Cross Blue Shield licensee in selected upstate counties only), Ohio, Virginia (excluding the Northern Virginia suburbs of Washington, D.C.), and Wisconsin. In a majority of these service areas, WellPoint does business as Anthem Blue Cross, Anthem Blue Cross and Blue Shield, Blue Cross and Blue Shield of Georgia, Empire Blue Cross Blue Shield, or Empire Blue Cross (in the New York service areas). WellPoint also serves customers throughout the country as UniCare. Additional information about WellPoint is available at http://www.wellpoint.com/.
About IBM
For more information, please visit http://www.ibmwatson.com./
To join the social discussion about Watson, www.ibm.com/social/watson, include the hashtag #ibmwatson in a tweet.
Follow Watson on Facebook: www.facebook.com/ibmwatson.SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains forward-looking information that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)", "intend", "estimate", "project" and similar expressions are intended to identify forward-looking statements, which generally are not historical in nature. These statements include, but are not limited to, statements regarding plans, objectives and expectations with respect to future operations, products and services. Such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include technical, business, financial, regulatory and/or legal issues that may arise in the development and/or implementation of the proposed WellPoint Watson solution. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by federal securities law, we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in WellPoint's and IBM's SEC reports.
SOURCE: WellPoint, Inc.