OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian devotee apparently works at the U.S. Food and Drug Administration (FDA), which sent a …

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Your Drug Patent Rights Transfer May Be Reportable, Court of Appeals Confirms

On Nov. 6, 2013, the Federal Trade Commission (FTC or Commission) modified its Hart-Scott-Rodino Act (HSR) rules to clarify that transfers of patent rights within the pharmaceutical industry constitute potentially reportable asset transactions even if patent holders retain limited manufacturing rights or …

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Dems Call for Hearing on Costs of Hep C Drug Sovaldi

Dialing up the issue of high-cost medications, Rep. Henry Waxman, the lead Democrat on the House Energy & Commerce Committee and Rep. Diana DeGette of Colorado are calling today for a hearing into the impact Sovaldi will have on Medicare spending. The letter references new data out of Georgetown University …

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STATE “RIGHT-TO-TRY” LAWS GAIN MOMENTUM

In an example of life imitating art, several states are considering “right-to-try” legislation to make experimental drugs—drugs that don’t have FDA approval—available to the terminally ill.  Colorado and Louisiana have already approved such laws.  Others, such as Minnesota, Missouri and Arizona, …

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STUDY LINKS 340B INCREASE TO HOSPITAL ACQUISITION OF PHYSICIAN PRACTICES

Last Thursday the Berkeley Research Group released a study attributing a sharp increase in the 340B drug discount program to the fact that hospitals across the country are acquiring physician-based oncology practices. The 340B program requires pharmaceutical manufacturers with Medicaid-covered products to give …

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Battle Over Cost of Drugs Ratchets Up

The battle over the rising costs of drugs, fueled by Gilead's Hepatitis C drug Sovaldi that costs $84,000 for a 12 week treatment regimen, intensified this week. Critics of the cost have taken to referring to the drug as the "1,000-a-day" pill. Earlier this week, the National Coalition on Health Care launched its …

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