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    Regulatory Job Seekers, Employers to Connect via RAPS Virtual Career Fair, 23 June

    RAPS will host its next Virtual Career Fair on Thursday, 23 June, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs are held regularly throughout the year. They are a convenient way for regulatory job seekers and employers looking to hire regulatory talent to connect online in real time. Prestige Brands is a confirmed exhibitor for the 23 June fair. Other employers who wish to participate can find out how to exhibit here . Participation in the event ...
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    Vermont Governor Signs Bill With Possible $10K Fines for Drug Price Hikes

    Vermont Gov. Peter Shumlin (D) on Friday signed into law a bill that would highlight drugs that the state spends significant amounts of money on, and companies owning those drugs could be hit with up to $10,000 in penalties if the wholesale acquisition costs rise too quickly and they fail to disclose the reasons for such hikes. Shumlin said Friday the bill was directed at providing answers on why pharmaceutical companies, like Turing Pharmaceuticals, disproportionately h...
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    European Regulators Drawn Into Debate on Drug Pricing

    Although drug regulators aren’t supposed to be concerned with pricing when making decisions on products’ safety and efficacy, they’re increasingly being drawn into what two representatives of the European Medicines Agency (EMA) and the heads of two national regulators call an “acrimonious debate” over drug costs. In a New England Journal of Medicine editorial published Thursday, EMA’s Executive Director Guido Rasi, its Senior Medical Officer Hans-Georg Eichler, the Exe...
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    Senate Committee Offers Inside Look at the Rise and Fall of Valeant Pharmaceuticals

    The 800 pages of internal emails, correspondence and drug pricing statistics released by the Senate Special Committee on Aging over the weekend offers an inside look at how the multibillion-dollar Valeant Pharmaceuticals with 22,000+ employees jacked up the prices of a number of drugs, by as much as 6,000%, and then lamented the subsequent media and investor questions. The document dump by the committee comes almost two weeks since the company’s former CEO, J. Michael Pe...
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    European Drug Prices: New Commission Report on What Policies Work and What Could Work

    The complicated world of drug pricing presents an array of challenges for keeping costs low in the US and EU, though European countries are increasingly employing new policies to keep price gouging in check. The 260-page report on drug pricing in Europe, released Thursday by the European Commission, looks into two policy options: external price referencing (EPR), which is predominantly a tool for medicine price control and currently employed across the region, and differ...
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    RAPS to Host First Virtual Career Fair of 2016 This Week

    RAPS will host its first Virtual Career Fair of 2016 this week on Thursday, 11 February, from 12:00 to 4:30 pm EST. RAPS’ Virtual Career Fairs are held regularly online and provide a convenient venue for regulatory job seekers and recruiters to connect confidentially in real time. Confirmed exhibitors for the 11 February fair are: GlaxoSmithKline Adecco Globus Medical Participation in the event is free for job seekers, who may register using th...
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    Expectations for 2016: Drug Pricing, Biosimilars, LDTs and More

    The end of 2015 saw the news spotlight shift to pharmaceutical pricing, with increased government scrutiny that could lead to actionable reforms in 2016, though other major stories expected in the coming year may steal some of that light, including how the US biosimilars market and regulation of lab-developed tests (LDTs) will develop, the fate of the 21st Century Cures bill and more. Drug Pricing When the New York Times broke the story of the now-infamous hedge funde...
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    Five Years of Cancer Drug Approvals: Most Cost Too Much and Give Us Too Little

    This is the guest post rebuttal (to this post from Mark Shapiro, VP of Clinipace) by Dr. Vinay Prasad, Assistant Professor of Medicine in the Division of Hematology Oncology in the Knight Cancer Institute. Prasad also  holds appointments in the Department of Public Health and Preventive Medicine, and as Senior Scholar in the Center for Health Care Ethics at Oregon Health & Science University. Mr. Shapiro comments on some of the arguments made in our investigation o...
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    Five Years of Cancer Drug Approvals: Pricing, Novelty and Improvement

    Mark Shapiro, vice president of clinical development at contract research organization Clinipace, considers a recent JAMA study on cancer drug pricing in a guest post for  Focus . A rebuttal to the post by one of the authors of the JAMA study, Dr. Vinay Prasad, can be found here . The last five years have been exceptionally busy in terms of oncology drug development. Two interesting articles that reflect back on this period of time were recently published. The firs...
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    Regulatory Recon: Shkreli Arrested on Securities Fraud Charges (17 December 2015)

    • 17 December 2015
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter. In Focus: US Shkreli, CEO Reviled for Drug Price Gouging, Arrested on Securities Fraud Charges ( Indictment )( Bloomberg ) ( New York Times ) ( Reuters ) FDA Schedules Advisory Committee to Review Sarepta DMD Drug ( FDA ) HHS OIG Report on...
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    New House Bill Seeks to Allow HHS to Negotiate Medicare Drug Prices

    Rep. Jan Schakowsky (D-IL) on Thursday introduced a new bill that would allow the Department of Health and Human Services (HHS) secretary to negotiate Medicare Part D prices for either sole-source drugs or biologics and are not manufactured by more than two drug companies. Under the bill, drug manufacturers and the secretary would have 90 days to negotiate the price of a drug covered by Medicare Part D. If the two parties fail to reach an agreement after the allotted tim...
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    Senate Committee Considers Priority Reviews to Stem the Tide of Off-Patent Drug Price Hikes

    Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for some off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward. The hearing, which is the first in a series that focuses on companies that, as Collins puts it, “act more like hedge funds than pharmaceutical companies,” follows letters sent to four specific companies – Valeant Pharmaceuticals, Turin...