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Cardinal Health Studies Affirm Importance of Patient Reported Outcomes for Improved Quality and Reduced Costs of Care

Patient-reported outcomes (PRO) can improve quality and reduce costs of care for high-cost, complex diseases, according to new clinical studies published by Cardinal Health Specialty Solutions. The company is unveiling a series of studies at the International Society of Pharmacoeconomic and Outcomes Research (ISPOR) annual meeting in Philadelphia, May 16-20, …

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Genentech’s Investigational Immunotherapy Doubles Survival in Mid-Stage Lung Cancer Trial

Roche’s Genentech recently announced that its investigational immunotherapy doubled the likelihood of survival in lung cancer patients with the highest level of a specific biomarker. Genentech, a member of the Roche Group, announced interim results from its mid-stage study in patients with previously treated non-small cell lung cancer (NSCLC). According …

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Express Scripts Report Finds Patients Taking At Least $100,000 Worth of Prescription Drugs Nearly Tripled in 2014

In 2014, the number of US patients taking at least $100,000 worth of medication nearly tripled from the previous year, according to a new report released from Express Scripts. Express Scripts released its new report, Super Spending: U.S. Trends in High-Cost Medication Use, which examines prescription drug use among patients …

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FDA Fast Tracks Merck KGaA’s Pancreatic Cancer Candidate

The US Food and Drug Administration (FDA) has granted Fast Track designation to Merck KGaA and partner Threshold Pharmaceuticals’ investigational pancreatic cancer drug. The companies won Fast Track status for the development of evofosfamide, administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally …

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FDA Staff Questions Benefit of Vertex’s Combo Cystic Fibrosis Drug

US health regulators released briefing documents Friday morning questioning the benefit of Vertex Pharmaceuticals’ combination therapy for cystic fibrosis patients. Ahead of an advisory panel review, scheduled for Tuesday, May 12, US Food and Drug Administration (FDA) staff reviewers questioned one of the two drugs in the combination cystic fibrosis …

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Baxter and Merrimack File for Approval of its Pancreatic Cancer Drug in Europe

Today, Baxter Bioscience and Merrimack Pharmaceuticals announced that the companies have submitted a marketing authorization application (MAA) for approval of its investigational treatment for patients with pancreatic cancer in Europe. The companies said that they have submitted an application to the European Medicines Agency (EMA) for approval of MM-398, also …

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FDA Issues Three Final Guidance Documents on Biosimilars

The US Food and Drug Administration (FDA) has issued three long-awaited documents with final guidance on biosimilars. In 2010, the agency passed the Biologics Price Competition and Innovation Act (BPCI) under the Patient Protection and Affordable Care Act. In 2012, the FDA released the first guidance documents in draft form. …

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Hospira Highlights the Importance of Extrapolation for Successful Development of Biosimilars Market

Hospira highlighted the importance of extrapolation in bringing biosimilars to patients at a medical conference last week. The company encouraged regulators to continue to adopt important scientific and clinical concepts of extrapolation, noting that Europe has 21 European Medicines Agency (EMA) approved biosimilars and the US Food and Drug Administration …

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Genzyme’s Lemtrada Slows Brain Atrophy in Multiple Sclerosis Extension Study

Today, Sanofi’s Genzyme announced its multiple sclerosis (MS) drug Lemtrada slowed brain atrophy in an extension study of a Phase III trial. The company announced new magnetic resonance imaging (MRI) data from the Lemtrada (alemtuzumab) clinical development program will be presented at the American Academy of Neurology (AAN) Annual Meeting. …

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Gilead and Merck Present Positive Data for Next-Generation Hepatitis C Drug Regimens

At The International Liver Congress, both Gilead Sciences and Merck announced positive results from hepatitis C trials, evaluating their next-generation hepatitis C combo drugs. Gilead revealed preclinical data and results from a mid-stage study supporting the development of its investigational all-oral, three-drug regimen of Sovaldi (sofosbuvir), the investigational NS5A inhibitor …

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