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Sanofi-aventis Welcomes The European Medicines Agency's Statement On Lantus® Safety
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that following the review of the available evidence on Lantus® (insulin glargine [rDNA] injection), the European Medicines Agency"s Committee for Medicinal Products for Human Use (CHMP) confirmed the product"s safety and concluded that changes to the prescribing advice are not necessary. The EMEA issued a press-release stating that they have re-confirmed their initial assessment, based on an
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National Public Reporting Of Health-Care-asociated Infections Supported By Experts
Five organizations representing the nation"s experts in infectious diseases medicine, infection prevention in healthcare settings, and public health and disease prevention announced their support for a provision requiring national reporting of healthcare-associated infection (HAI) rates, which is contained within the healthcare reform bill introduced by leaders of the U.S. House of Representatives.
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Senate Finance Committee Discusses Funding For Health Reform In Final 'Walk Through' Meeting
The Senate Finance Committee met Wednesday to discuss potential funding mechanisms for health reform legislation but indicated that no concrete decisions had been reached, The Hill reports. The meeting was the third of three scheduled to "walk through" various aspects of health reform. Previous talks focused on the care delivery system and coverage. Finance Committee Chair Max Baucus (D-Mont.) has said that he hopes for a bill to be approved for full Senate consideration by the end of July. He said of the talks so far, "We"ve got a lot of work ahead of us," adding, "Soon we have a mark up, soon we have a bill, and that realization is forcing us to make decisions." He also said, "Nothing"s pushed off the table. We"re looking at it all." Funding mechanisms discussed Wednesday included taxes on sugary and alcoholic beverages, as well as a limit on the tax-exempt status of employer-provided health insurance (Young, The Hill, 5/20). One proposal would raise the federal alcohol excise tax by 145% for beer, 233% for wine and 20% for hard liquor (Hurt, New York Post, 5/21). The committee also mulled a three-cent tax per 12-ounce container of sugary drinks, which would raise an estimated $50 billion over 10 years (Alonso-Zaldivar, AP/Houston Chronicle, 5/21). Baucus said he supports placing a cap on the employer coverage tax exemption based on income or the cost of premiums, or both. Congress estimates that about $194.2 billion in revenue is passed up each year by forgoing taxes on the insurance plans. The committee also discussed decreasing Medicare spending on home care, durable medical equipment, medical imaging and prescription drugs, as well as addressing regional disparities in health care costs (The Hill, 5/20). Members also brought up the possibility of charging higher-income seniors higher premiums for the Medicare prescription drug benefit (Wayne, CQ Today, 5/20). Members also discussed introducing new standards for not-for-profit hospitals that would require them to provide more no-cost care and serve more low-income patients in order to keep their tax-exempt status. In addition, they discussed cutting special Medicare payments to teaching hospitals, as well as requiring drugmakers to give larger discounts to state Medicaid programs (Pear, New York Times, 5/21).Baucus noted "convergence" on some issues, such as the need to include complete funding in a reform package, as well as the need to establish insurance exchanges that would facilitate the purchase of public or private insurance (The Hill, 5/20). Committee ranking member Chuck Grassley (R-Iowa) said, "There was a greater understanding of the issues we have," but there are "a lot of members who still want some more understanding." Grassley also said, "There"s just a lot of questions; there are -- I wouldn"t say misunderstandings, but there"s got to be a lot of understanding about what you"re talking about" (CQ Today, 5/20). Chances of Bipartisan Bill
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Cytokinetics Announces The Initiation Of A First-Time-in-Humans, Phase I Clinical Trial Of CK-2017357

Cytokinetics, Incorporated (NASDAQ: CYTK) announced that the company has initiated a first-time-in-humans, Phase I clinical trial of CK-2017357 in healthy male volunteers. CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate that has emerged from the company"s skeletal sarcomere activator program. CK-2017357 selectively activates the troponin complex and increases its sensitivity to calcium, subsequently leading to an increase in skeletal muscle force. This mechanism of action has demonstrated encouraging pharmacological activity in preclinical models that may relate to the potential treatment of diseases associated with aging, muscle wasting, and neuromuscular dysfunction. This Phase I clinical trial is a double-blind, randomized, placebo-controlled, single ascending dose study designed to evaluate CK-2017357 in healthy male volunteers. Each volunteer will participate in two dosing sessions separated by an adequate washout period. Subjects will be randomized (3:1) at the start of each dosing period to receive active study drug or placebo. The primary objective of this clinical trial is to determine the safety, tolerability and maximum tolerated dose (MTD) of CK-2017357 administered orally. The secondary objective is to evaluate the pharmacokinetic profile of CK-2017357. Following determination of the MTD and the pharmacokinetic profile of CK-2017357, further evaluation of the drug candidate"s pharmacodynamic effects on skeletal muscle function in healthy volunteers may be undertaken in a second stage of this clinical trial. "This first-time-in-humans clinical trial of CK-2017357 builds on our expertise in the biology of muscle function, initially demonstrated with our cardiac muscle myosin activator program and now translated to our skeletal sarcomere activator program," stated Fady Malik, MD, PhD, Cytokinetics" Vice President, Biology and Therapeutics. "This novel drug candidate may represent an important approach to treating skeletal muscle weakness that is a consequence of a wide array of diseases associated with muscle wasting or primary neuromuscular dysfunction." "The initiation of this Phase I clinical trial is further demonstration of Cytokinetics" expertise in building a portfolio of novel drug candidates that leverage our expertise in the cytoskeletal pharmacology and biology of muscle contractility," stated Robert I. Blum, Cytokinetics" President and CEO. "This drug candidate, along with others we are developing, illustrates the productivity of our research and development teams that have now generated five next-generation drug candidates, which may address significant unmet needs across multiple therapeutic indications." Background on Skeletal Muscle Activators Skeletal muscle contractility is driven by the sarcomere, the fundamental unit of skeletal muscle contraction. It is a highly ordered cytoskeletal structure composed of several key proteins. The first, skeletal muscle myosin, is the cytoskeletal motor protein that converts chemical energy into mechanical force through its interaction with a second protein, actin. A set of regulatory proteins, which includes tropomyosin and several types of troponin, make the actin-myosin interaction dependent on changes in intracellular calcium levels. Cytokinetics" skeletal muscle contractility program is focused to the discovery and development of small molecule skeletal sarcomere activators and leverages Cytokinetics" expertise gained from its ongoing discovery and development of cardiac sarcomere activators, including the cardiac myosin activator, CK-1827452, now in Phase II clinical development as a potential treatment for heart failure. In non-clinical models, skeletal sarcomere activators have demonstrated pharmacological activity that may lead to new therapeutic options for diseases associated with aging, muscle wasting, and neuromuscular dysfunction. The clinical effects of muscle wasting, fatigue and loss of mobility can range from decreased quality of life to, in some instances, life-threatening complications. By directly improving skeletal muscle function, a small molecule activator of the skeletal sarcomere may potentially enhance physical performance and quality of life in patients with conditions marked by muscle weakness, including neuromuscular diseases such as amyotrophic lateral sclerosis (ALS), myasthenia gravis, cachexia, sarcopenia and the general frailty associated with aging. Market Potential for Skeletal Muscle Activators The conditions that could benefit from a skeletal muscle activator are grievous and severe. ALS, which afflicts between 20,000 and 30,000 people in the United States and is associated with a 3-year mortality rate of 50%. In addition, few options exist for the treatment of other neuromuscular disorders, such as myasthenia gravis, a chronic disease characterized by a defect in the transmission of nerve impulses to skeletal muscles, which afflicts approximately 60,000 patients in the United States. Patients with disorders and conditions with a higher prevalence could also benefit from enhanced skeletal muscle functional performance, including patients with cachexia, intermittent claudication and sarcopenia. Cachexia, a syndrome characterized by a drastic and unintentional loss of body mass, is estimated to be prevalent in 15%-35% of heart failure patients and in approximately 50% of cancer patients. Intermittent claudication, which usually refers to cramping pains in the legs caused by peripheral arterial disease, is a condition that impacts between 1 million and 3 million people in the United States each year. Sarcopenia, which is an age-related loss of muscle mass, strength, and function, is estimated to impact the lives of over 25-30% of the U.S. population over the age of 65 and can result in additional injuries and medical conditions due to limited mobility. Cytokinetics


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