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Oncolytics’ Reolysin Receives Orphan Drug Designations from the FDA

Oncolytics Biotech Inc.’s lead product candidate Reolysin was granted orphan drug designation for two types of cancer this week. The company announced Monday that the US Food and Drug Administration (FDA) granted the drug orphan drug designation for Reolysin for the treatment of cancer of the fallopian tube. On Tuesday, …

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Boston Scientific Buys Endo’s Urology Device Business for $1.6 Billion

Medical device maker Boston Scientific Corp is buying Endo International’s men’s health and prostate businesses for up to $1.65 billion. The companies have entered into a definitive agreement, under which Boston Scientific will acquire the American Medical Systems urology profile, which includes the Men’s Health and Prostate Health businesses, for …

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FDA Grants Priority Review to Bristol-Myers Squibb’s PD-1 Inhibitor for Treatment of Lung Cancer

US health regulators have accepted, and granted Priority Review, for Bristol-Myers Squibb Company’s (BMS) lung cancer drug. BMS announced that the US Food and Drug Administration (FDA) has accepted for filing and review the Biologics License Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small …

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Rosetta Genomics Advances Development of its Differentiated Thyroid Cancer Assay

Molecular diagnostics company, Rosetta Genomics Ltd., announced that its novel assay for differential diagnosis of thyroid neoplasia is on track for launch by the end of the third quarter of 2015. The company provided an update on the development of its microRNA-based assay for the differential diagnosis of thyroid neoplasia, …

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NICE Recommends Use of Pfizer’s Inlyta in Kidney Cancer and Rejects Dendreon’s Provenge for Prostate Cancer

The National Institute for Health and Care Excellence (NICE) issued two final guidelines, recommending Pfizer’s Inlyta (axitinib) in kidney cancer, but rejecting Dendreon’s Provenge (sipuleucel-T) in prostate cancer. In guidance issued to the NHS, the drug pricing watchdog recommended Inlyta as a second-line option for treating adults with advanced renal …

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Four New Centers Join World’s Largest Precision Cancer Research Network

The Oncology Research Information Exchange Network (ORIEN), founded by Moffitt Cancer Center and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCC-James), announced that it has expanded with the addition of four nationally recognized cancer centers. ORIEN, a research …

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Genzyme Provides Postmarket Study Results for its Gaucher Disease Drug

Sanofi’s Genzyme recently announced that treatment with its Cerdelga (eliglustat) reduced spleen size 28 percent compared to placebo in patients with Gaucher disease. The company announced that results from the ENGAGE registration study evaluating Cerdelga in treatment-naïve patients with Gaucher disease type 1 were published in The Journal of the …

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New Affordable Care Act Initiative Aims to Improve Cancer Care and Cut Costs

Today, the US Department of Health and Human Services (HHS) announced a cancer care initiative for Medicare beneficiaries that will link payments to oncology practices to quality of care and patient outcomes. The New Affordable Care Act initiative, by the Centers for Medicare and Medicaid Services (CMS), is in support …

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