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Monthly Archives: February 2015

Amgen’s AMG 416 Demonstrates Positive Results in its Late-Stage, Head-to-Head Study with Sensipar

Amgen’s investigational AMG 416 succeeded in its final late-stage study for secondary hyperparathyroidism in patients with chronic kidney disease. The company announced results from the head-to-head Phase III study comparing AMG 416 with its in-house rival Sensipar (cinacalcet) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney …

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Bristol-Myers Squibb’s Hep C Drug Helps Cure 97 Percent of Patients Coinfected with HIV

Bristol-Myers Squibb Company (BMS) recently announced that 97 percent of hepatitis C patients also infected with HIV were cured of the liver virus after 12 weeks of treatment with the company’s dacatasvir and Gilead Sciences’ Sovaldi. Historically, patients with chronic hepatitis C virus (HCV) coinfected with HIV have been challenging …

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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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FDA Postpones Advisory Meeting on Biosimilar Copy of Remicade

The US Food and Drug Administration (FDA) has postponed an advisory committee meeting to consider approval of Hospira and partner Celltrion’s biosimilar of Remicade. The agency said that it wants more time to review the Biologics License Application (BLA) for CT-P13, a proposed biosimilar to Janssen Biotech Inc.’s Remicade (infliximab), …

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Celltrion and Hospira Launch Biosimilars of Remicade in Major European Markets

Partners Hospira, Inc. and Celltrion Healthcare have launched a biosimilar version of Johnson & Johnson’s autoimmune drug Remicade across major European markets. Together, the companies are launching their biosimilar products in twelve European markets, including Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK. …

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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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AstraZeneca Partners With Orca for Development of Oral Autoimmune Drugs

AstraZeneca is collaborating with UK-based Orca Pharmaceuticals to develop new drugs for a wide range of autoimmune diseases. The companies announced a three year collaboration to develop inhibitors of retinoic acid-related orphan nuclear receptor gamma (RORγ), which is believed to have potential against a wide range of autoimmune diseases for …

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Stick With It

A cure for multiple sclerosis (MS) remains elusive, although there are numerous disease modifying treatments available which aim to calm inflammation and lengthen the time between relapses. Not surprisingly, patients with the most faithful use of their prescriptions have the fewest relapses, says a new study of MS adherence published …

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