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Gut-on-a-Chip Provides Insight into Microbiome & Intestinal Inflammation

Lara C. Pullen, PhD  |  February 8, 2016

Researchers have created a microdevice with Caco-2 intestinal epithelial cells to aid in studying the human gut microbiome’s role in homeostasis, immune modulation and pathology. Using this gut-on-a-chip, researchers were able to examine in detail the processes they think result in chronic intestinal inflammation…

No Cause Found Yet for Botched French Drug Trial

Reuters Staff  |  February 7, 2016

PARIS (Reuters)—An initial report into a drug trial in northwestern France that left one person dead and five others hospitalized last month did not identify the exact cause, French Health Minister Marisol Touraine said on Thursday. Touraine told a news conference that the condition of the five people who were hospitalized was improving and that…

Bowing to Pressure, FDA to Reform Painkiller Approval Process

Toni Clarke  |  February 7, 2016

WASHINGTON (Reuters)—Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama’s nominee to lead the U.S. Food and Drug Administration (FDA), said on Thursday the agency would reform its process for approving opioid painkillers. Last month, Sen. Edward Markey (D-Ma.) placed a hold on Califf’s nomination, preventing it from being voted on by the…

U.S. Appeals Court: Hospitals Can Be ‘Urban’ & ‘Rural’ at Same Time

Jonathan Stempel  |  February 6, 2016

NEW YORK (Reuters)—The federal appeals court in New York struck down a U.S. regulation that made it harder for hospitals to provide better medical care at lower cost by claiming they were “rural” for some purposes and “urban” for others. Thursday’s decision by the Second U.S. Circuit Court of Appeals is a victory for hospitals…

FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade

Reuters Staff  |  February 6, 2016

(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…

California Doctor Gets 30 Years to Life in Landmark Overdose Case

Steve Gorman  |  February 6, 2016

LOS ANGELES (Reuters)—A Southern California doctor was sentenced to 30 years to life in prison on Friday for over-prescribing drugs that caused the fatal overdose of three patients in a murder case capped by the first conviction of its kind in the U.S. The case against Dr. Hsiu Ying “Lisa” Tseng, 46, comes amid what…

The Genetic Factor: Research Examines Genetic Heritability for Pediatric Autoimmune Diseases

Richard Quinn  |  February 5, 2016

Recent research has helped further define genetic heritability for pediatric autoimmune diseases. In an interview, Dr. Hakon Hakanarson discusses how understanding common genetic factors can help develop risk prediction and treatments for such diseases as juvenile idiopathic arthritis, lupus and celiac disease…

Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis

Michele B. Kaufman, PharmD, BCGP  |  February 3, 2016

An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…

CVS to Make Overdose Drug Naloxone Prescription-Free in Ohio

Reuters Staff  |  February 3, 2016

(Reuters)—CVS Health Corp said it would make naloxone, available without a prescription at all its pharmacies across Ohio, a state with one of the highest rates of overdose-related deaths. Naloxone is already available without a prescription in CVS Health stores in more than a dozen states. Drug overdoses increased 6.5% in 2014 from a year…

U.S. Appeals Court Ruling May Clear Barrier to Generic OxyContin

Brendan Pierson  |  February 3, 2016

(Reuters)—A federal appeals court ruled Monday that four patents related to Purdue Pharma’s painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug. Privately owned, Connecticut-based Purdue had sued Teva, Amneal Pharmaceuticals and Epic Pharma after they sought approval from the U.S. Food…

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