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A group of Democrats in the U.S. House of Representatives reintroduced a bill, H.R. 2031, that would impose stronger reporting requirements on the U.S. clinical trial registry data bank, clinicaltrials.gov. The Trial …
Published on 5/17/2013
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A legal analysis released Thursday by Sen. Tom Coburn (R-Okla.) indicates that if members of Congress fail to confirm members of a controversial Medicare cost-containment board, HHS Secretary Kathleen Sebelius would be …
Published on 5/17/2013
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The U.S. House of Representatives voted 416-6 to pass a bill, H. R. 701, that gives the U.S. Securities and Exchange Commission an Oct. 31 deadline to complete rulemaking on the reforms under the Jumpstart Our Business …
Published on 5/16/2013
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The U.S. House Energy and Commerce committee agreed by voice vote on Wednesday to send to the full U.S. House of Representatives a bill that would create a national system for tracking and tracing pharmaceutical …
Published on 5/15/2013
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NIH's National Center for Advancing Translational Sciences (NCATS) is seeking input on its proposed plan to avoid the "potential duplication, redundancy and competition" of the center's efforts with industry activities.…
Published on 5/15/2013
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The U.K.'s NICE said it will publish about 40 "Medtech Innovation Briefings" annually to provide objective information on devices and diagnostics to help boost the uptake of the technologies within NHS. The agency said …
Published on 5/15/2013
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The U.S. Senate voted 91-7 with two abstentions on Wednesday to confirm Marilyn Tavenner as CMS administrator. Tavenner, who has been CMS's acting administrator since Donald Berwick stepped down in December 2011, is the…
Published on 5/15/2013
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A bipartisan group of senators introduced into the U.S. Senate on Wednesday a bill that would streamline drug supply chain tracking, while a separate bipartisan group of senators introduced a bill that would make …
Published on 5/15/2013
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The U.S. House of Representatives Energy and Commerce Committee sent a letter to FDA Commissioner Margaret Hamburg seeking information about the departure this month of Leona Brenner-Gati as acting deputy commissioner …
Published on 5/14/2013
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The U.S. Department of Justice filed a motion in the U.S. Court of Appeals for the Second Circuit for a stay, pending appeal, of an April order from a judge in the U.S. District Court for the Eastern District of New …
Published on 5/13/2013
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HHS's Office of Inspector General (OIG) said Medicare would have saved $510 million in 2011 on erythropoietin stimulating agents (ESAs) Aranesp darbepoetin alfa and Epogen epoetin alfa if the bundled payment rate for …
Published on 5/13/2013
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Following a string of setbacks and muddy rulings in biotech patent cases, the biotech industry won an unambiguous victory Monday in a case pitting an individual farmer against Monsanto Co. (NYSE:MON). The U.S. Supreme …
Published on 5/13/2013
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The U.K.'s Technology Strategy Board will have a budget of L440 million ($675.9 million) for 2013-14, about L50 million ($76.8 million) more than its budget last year. The board's Delivery Plan for the year calls for up…
Published on 5/13/2013
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Judge Edward Korman in the U.S. District Court for the Eastern District of New York denied a request for a stay of an April order compelling FDA to make emergency contraceptives containing levonorgestrel available OTC …
Published on 5/10/2013
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House Speaker John Boehner (R-Ohio) and Senate Minority Leader Mitch McConnell (R-Ky.) sent a letter to President Obama on Friday declining his request to recommend appointments to the Independent Payment Advisory Board…
Published on 5/10/2013
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FDA issued two draft guidances composed of questions and answers on expanded access to investigational drugs or biologics and the circumstances in which companies can charge for an investigational drug. The guidances …
Published on 5/9/2013
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According to a report from IMS Health, annual per capita spending on medicines in the U.S. fell 3.5% to $898 in 2012 due to increased use of generics, lower levels of price increases and reduced spending on new drugs. …
Published on 5/9/2013
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Merck & Co. Inc. (NYSE:MRK) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) will provide their respective HPV vaccines to developing countries at discounted prices through deals with the Global Alliance for Vaccine …
Published on 5/9/2013
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Two sets of stakeholders expressed support for FDA's proposed benefit-risk assessment framework and stressed the need for greater predictability in the review process. The Pharmaceutical Research and Manufacturers of …
Published on 5/9/2013
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The U.S. House Energy and Commerce Committee's health subcommittee voted on Wednesday to send to the full committee a discussion draft of legislation that would create a national system for tracking and tracing …
Published on 5/8/2013
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NIH said sequestration cuts have the agency operating at a program level of $29.2 billion for FY13, a 5% decrease from FY12's budget of $30.8 billion. The drop -- outlined in a notice on Wednesday -- is in line with the…
Published on 5/8/2013
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FDA Commissioner Margaret Hamburg said the agency's Murray Lumpkin will serve as a senior fellow at the not-for-profit Bill & Melinda Gates Foundation to work on issues related to regulatory systems and processes in the…
Published on 5/7/2013
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Sen. Tom Harkin (D-Iowa) lifted his hold on President Obama's nomination of Marilyn Tavenner's as CMS administrator. Harkin said he placed the hold to give White House officials time to reconsider a directive Tavenner …
Published on 5/7/2013
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The Li Ka Shing Foundation and the U.K. government each provided L20 million ($31 million) in funding to build the Li Ka Shing Center for Health Information and Discovery, a new research center at the University of …
Published on 5/7/2013
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The Patient-Centered Outcomes Research Institute approved awards totaling $88.6 million over three years for 51 comparative clinical effectiveness research projects addressing the first four of PCORI's five research …
Published on 5/7/2013