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Ilaris® Recommended For European Approval As New Biologic Drug To Treat A Rare But Serious Group Of Auto-inflammatory Diseases
The biotechnology medicine Ilaris® (canakinumab) has passed another major milestone with a recommendation for approval in the European Union to treat patients with a life-long and potentially fatal auto-inflammatory disease called cryopyrin-associated periodic syndrome (CAPS). When approved, Ilaris will be the only treatment in the EU indicated for CAPS patients aged four years and older[1].

Light-Treatment Device Developed To Improve Sleep Quality In The Elderly
Sleep disturbances increase as we age. Some studies report more than half of seniors 65 years of age or older suffer from chronic sleep disturbances. Researchers have long believed that the sleep disturbances common among the elderly often result from a disruption of the body"s circadian rhythms - biological cycles that repeat approximately every 24 hours.
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CytRx's Tamibarotene Receives Positive Opinion From The Committee For Orphan Medicinal Products In The European Union For Treatment Of APL
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, announced that its lead drug candidate tamibarotene has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of acute promyelocytic leukemia (APL). The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register. This favorable opinion for tamibarotene in the European Union (EU) is in addition to the Orphan Drug Designation for APL and Fast Track Designation for the treatment of adult patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide granted by the U.S. Food and Drug Administration (FDA) in October 2007.
Mental Health

New Medicare Nursing Home Guidance To Include Quality Of Life And Environment Requirements

The Centers for Medicare & Medicaid Services (CMS) issued new guidance for nursing home surveyors, further defining and clarifying several important dimensions of care to help improve nursing home residents" quality of life and environment. Beginning June12, 2009, nursing home surveys will be conducted with a sharpened focus on resident rights in key areas such as: - Ensuring they live with dignity; - Offering choices in care and services; - Accommodating the environment to each of their needs and preferences; and - Creating a more homelike environment - including access for visitors. Currently, nearly 1.5 million individuals live in approximately 15,800 nursing homes on any given day, and about 3 million people will spend some time in a nursing home each year. "These groundbreaking revisions matter in the daily lives of people who live in the nation"s long-term care facilities," said CMS Acting Administrator Charlene Frizzera. "The improvements in the guidance are intended to support efforts underway to transform nursing homes into environments that are more like their homes through both environmental changes and resident-centered caregiving." The new guidance also calls on nursing homes to de-institutionalize their physical environments. The guidance highlights institutional practices that facilities should strive to eliminate including meals served on institutional trays and noise from overhead paging systems, alarms and large nursing stations. A homelike environment is not achieved simply through enhancements to the physical environment, according to the new guidance. It concerns striving for person-centered care that emphasizes individualization, relationships, and a psychological environment that welcomes each resident and offers comfort. The guidance also makes clear that residents have the right to choices concerning their schedules -consistent with their interests, assessments, and plans of care. Choice over schedules includes, but is not limited to, those matters that are important to the resident, such as daily waking, eating, bathing, and going to bed at night. The facility should gather this information in order to be proactive in assisting residents to fulfill their choices. CMS inspects nursing homes periodically to ensure they meet the federal regulations requiring that each resident receive good quality care in a home that also provides good quality of life. CMS provides guidance, such as today"s release, to help surveyors interpret those regulations. The new guidance provides a substantial roadmap for environmental and culture change in nursing homes, while noting that some facilities are further along than others. As noted in the guidance: "many facilities cannot immediately make these types of changes, but it should be a goal for all facilities that have not yet made these types of changes to work toward them." The guidance can be found here. Centers for Medicare & Medicaid Services


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