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Zerenex™ (Ferric Citrate) Long-Term Phase 3 Study Results Published in the Journal of the American Society of Nephrology

Keryx Biopharmaceuticals, Inc. announced the publication of results from the long-term, randomized, active control Phase 3 study of Zerenex (ferric citrate), the Company's investigational oral ferric iron-based phosphate binder, for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis. The PERFECTED study (PhosphatE binding and iRon delivery with FErric CiTrate in EsrD) was published online today in the Journal of the American Society of Nephrology (JASN).

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Drug Approved to Treat Rare Disorder Associated with Anesthesia

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Eagle Pharmaceuticals, Inc. today announced the U. S. Food and Drug Administration (FDA) has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.

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UNC Researchers Find Unsuspected Characteristics of New CF Drugs

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In lab experiments using tissue samples cultured from cystic fibrosis patients, scientists at the UNC School of Medicine and the UNC Marsico Lung Institute have shown that a new CF drug counteracts the intended beneficial molecular effect of another CF drug.

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Beckman Coulter’s phi Named in NCCN Guidelines as a Recommended Diagnostic Test for Early Prostate Cancer Detection

Beckman Coulter’s Prostate Health Index (phi)* has been recommended by the National Comprehensive Cancer Network (NCCN) as a blood test to improve specificity for prostate cancer detection in its recently updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer Early Detection. Inclusion in the NCCN Guidelines recognizes the benefit and clinical utility of phi for better prostate cancer diagnosis and for the reduction of unnecessary biopsies.

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New Prostate Cancer Blood Test Now Available in the US

Beckman Coulter Diagnostics, a global leader in prostate cancer diagnostics, announces national availability of the Prostate Health Index (phi)*, a simple, non‐invasive blood test that is three times more specific in detecting prostate cancer1 than PSA (prostate‐specific antigen). The new test’s accuracy decreases the need for many men who test positive for elevated PSA levels to undergo a biopsy in order to achieve a reliable diagnosis.

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hc1.com® and Beckman Coulter Diagnostics Enter Strategic Partnership to Bring Innovative Healthcare Cloud Technology to Laboratories

hc1.com®, the Healthcare Relationship CloudTM company, and Beckman Coulter Diagnostics, a global leader in developing clinical diagnostic products that help advance and optimize the laboratory, announced a strategic partnership to deliver innovative technology to laboratories that turn large amounts of clinical data into actionable insights that transform how labs manage their business and their contributions to improving healthcare.

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COLA Leadership Summit Concludes with a Path Forward

COLA, the largest private accreditor of medical laboratories serving more than 8,000 across the U.S., successfully concluded its 2014 Leadership Summit in April. More than 30 thought leaders in health care, including physicians, regulators, public health experts, medical laboratory scientists, manufacturers, nurse practitioners and more gathered in San Francisco to discuss the future of laboratory medicine in the context of the Affordable Care Act (ACA). The group explored the implications of the dynamics of ACA and changing payment policies on quality and learning in laboratory medicine.

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COLA: Helping Labs Prepare for the Healthcare Future

The nation’s healthcare system -- and with it, the laboratory community – is undergoing a period of tremendous change as The Affordable Care Act begins implementation and new healthcare delivery models such as The Patient-Centered Medical Home (PCMH) and Accountable Care Organizations (ACOs) proliferate. With more than 70 percent of medical decisions based on lab data, laboratories are emerging as vital partners of these new healthcare teams. Labs are uniquely qualified to use the patient data they capture to provide feedback to allied health professionals that can increase efficiency and contain health-care costs while improving patient care.

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CRI-COLA's New Subsidiary Acts As Education Arm

COLA Inc., based in Columbia, MD, an independent, nonprofit laboratory CLIA-accreditation organization, accrediting more than 7,000 clinical diagnostic labs on July, 2013, launched a new education subsidiary, COLA Resources Inc. (CRI®), whose mission is to “Provide educational & consultative services aimed at improving laboratory medicine and patient care.”

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FDA Grants Diazyme 510(k) Clearance to Market Its Vitamin D Assay for Clinical Chemistry Analyzers

Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its Vitamin D assay for Clinical Chemistry Analyzers. In line with the rapid increasing clinical demands for testing of this important biomarker, Diazyme’s new Vitamin D assay, utilizing its femtoquantTM technology (a sensitive homogenous enzyme-immunoassay platform), provides the first fully automated Vitamin D test for use on general clinical chemistry analyzers. Diazyme’s Vitamin D assay measures total 25-hydroxy Vitamin D (sum of 25-(OH)D3 + 25-(OH)D2 ) levels.

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