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    The Next Emflaza: Acer Therapeutics Looks to Take a Page Out of Marathon's Book

    Last year, Marathon Pharmaceuticals took an inexpensive steroid available for sale in the EU and Canada and brought it through the US Food and Drug Administration's (FDA) approval process before trumpeting an $89,000 annual price. The move, criticized by lawmakers and others and then the company was bought by PTC Therapeutics, offered a test case for how a company can use FDA's approval system and the US pricing system to reap outsized rewards without doing any ...
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    Arbitrary Pharmaceutical Price Gouging: Valeant Defends its Business Model

    As the anger over Martin Shkreli’s infamously steep and entirely arbitrary price hike of a rare disease drug has subsided, Congress has begun to turn its attention to other companies, such as Valeant Pharmaceuticals, which rely on price gouging as a foundation of their business models. On Wednesday, the Senate’s Special Committee on Aging grilled not only Valeant’s outgoing CEO, J. Michael Pearson, but its former chief financial officer, Howard Schiller, and one of the c...
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    Senators Slam Execs of Shkreli's Former Company Over Arbitrary Price Hike on Lifesaving Drug

    The Senate’s Special Committee on Aging held its second hearing on pharmaceutical pricing on Thursday, this time taking shots at executives of Martin Shkreli’s former company Turing Pharmaceuticals, which only exists because of a monopoly and 5,000% price hike on a toxoplasmosis drug first approved more than 50 years ago. The first panel of witnesses included a couple whose newborn was diagnosed with toxoplasmosis but after their insurers denied coverage for the drug, kn...
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    House Hearing Focuses on Harm Done by Drug Price Spikes

    The highly anticipated House Oversight Committee hearing on Thursday was not without its fireworks, though beyond the airing of a lot of discontent, few new options for halting drug price increases were brought to the table. About an hour into the hearing, Martin Shkreli, former CEO of Turing Pharmaceuticals, who previously called the increase in price of a toxoplasmosis drug a “very handsome investment,” was escorted out after he used his Fifth Amendment rights to avo...
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    Congress Offers New Details on Drug Price Spikes

    Ahead of a Thursday hearing with US Food and Drug Administration (FDA) CDER Director Janet Woodcock sitting beside former Turing CEO Martin Shkreli, the House Oversight Committee has released documents where the former hedge fund manager calls the price hikes of a toxoplasmosis treatment “a very handsome investment.” “We raised the price from $1,700 per bottle to $75,000 … So 5,000 paying bottles at the new price is $375,000,000—almost all of it is profit and I think we ...
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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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    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...