Hospitals are itching for a share of the Mylan settlement over Medicaid rebates

More than 1,200 hospitals around the country want to know if they were overcharged by Mylan Pharmaceuticals for the EpiPen auto-injector. In a letter sent earlier this week to the Department of Justice, an industry trade group called 340B Health cited a recent settlement in which Mylan agreed to pay $465 million to resolve accusations of shortchanging Medicaid by failing […]

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FDA emails show how upset some officials were over the Sarepta approval

Newly disclosed emails underscore the extent to which high-ranking US Food and Drug Administration officials were upset with the decision-making process used to approve a controversial Sarepta Therapeutics drug for combating Duchenne muscular dystrophy. The Sept. 14 emails were written in response to a memo that Dr. Robert Califf, the FDA commissioner had drafted in which he […]

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What clinical trial results? Now you can see who isn’t sharing their findings

during the last decade have not been published, and one company — Ranbaxy Laboratories — has not published findings for any of the nearly three dozen trials conducted in the past 10 years, according to a new online tool. The tool was launched Thursday by AllTrials, a consortium of researchers and medical journals that has been pushing the pharmaceutical industry to […]

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Brexit could put patients’ lives at risk, new report warns

Uncertainty in the UK over Brexit is making the pharmaceutical industry very anxious, but could also put the lives of patients “at risk,” according to a new report, which seeks to persuade government officials to look beyond the usual warnings from drug makers about reduced investments in the country. To be clear, the findings reiterate […]

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West Virginia AG vows to reject ‘woefully deficient’ Mylan deal with the feds

In blunt language, West Virginia Attorney General Patrick Morrisey is vowing to reject the settlement between the federal government and Mylan Pharmaceuticals, which was accused of shortchanging Medicaid. In a letter to US Attorney General Loretta Lynch, he called the $465 million “woefully deficient” compared with the “fraud” perpetrated by the drug maker and urged the Department of Justice […]

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Antibiotic maker’s stock sinks after FDA notes safety signal

At a time of growing interest in antibiotic development, a Wall Street bet on what some billed as a potential blockbuster appears to be going sour. After regulators on Wednesday released a gloomy assessment of an experimental antibiotic developed by Cempra to combat community-acquired pneumonia, its stock sank as much as 58 percent. That’s because of a […]

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