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The Internal Revenue Service proposed a rule on Friday that would implement a 2.3% excise tax on the sales price of certain medical devices sold after Dec. 31, 2012. The excise tax was mandated by the Patient Protection…
Published on 2/3/2012
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Sen. Barbara Mikulski (D-Md.) introduced the Spending Reductions through Innovations in Therapies (SPRINT) Act, which would create a program to fund awards, grants, contracts and cooperative agreements to spur R&D for …
Published on 2/2/2012
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The Critical Path Institute hired Carolyn Compton as president and CEO. Compton was previously director of the office of biorepositories and biospecimen research at the National Cancer Institute (NCI) and executive …
Published on 2/1/2012
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FDA and the medical device industry reached an agreement in principle on MDUFA reauthorization that would allow the agency to collect $595 million in user fees for FY2013-17. FDA was seeking a user fee package of up to…
Published on 2/1/2012
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The House Energy and Commerce Committee's health subcommittee raised no major roadblocks to PDUFA V enactment at a hearing Wednesday and Chairman Joe Pitts (R-Pa.) said he still hopes to pass the legislation by June 30.…
Published on 2/1/2012
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FDA released a report Tuesday outlining transparency initiatives the agency will explore to increase public access to information on regulatory compliance and enforcement. The report contains eight initiatives that the …
Published on 1/31/2012
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The Pharmaceutical Research and Manufacturers of America named Mit Spears EVP and general counsel. Spears was previously a partner at law firm Ropes & Gray. Spears replaces Diane Bieri, who stepped down in December.
Published on 1/31/2012
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Rep. Brett Guthrie (R-KY) introduced a bill (H.R. 3827) that would repeal the Patient-Centered Outcomes Research Institute and funding for comparative effectiveness research. PCORI was established by the Patient …
Published on 1/31/2012
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The Centers for Medicare & Medicaid Services issued a proposed rule to implement changes to Medicaid in the Patient Protection and Affordable Care Act, including increasing rebates paid by drug manufacturers. The law …
Published on 1/30/2012
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The Pharmaceutical Research and Manufacturers of America transferred the development of its benefit-risk assessment program to the U.K.'s Centre for Innovation in Regulatory Science Ltd. CIRS will incorporate PhRMA's …
Published on 1/30/2012
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FDA Center for Drug Evaluation and Research Director Janet Woodcock asked Robert Temple to give up his role as acting director of the Office of Drug Evaluation I to devote more time to his other role as deputy center …
Published on 1/30/2012
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The Obama administration filed a brief with the U.S. Supreme Court arguing that the entire Patient Protection and Affordable Care Act should not be struck down if the court finds the individual insurance mandate …
Published on 1/30/2012
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The U.S. House Energy and Commerce Committee's health subcommittee released the list of witnesses who will testify at Wednesday's hearing on PDUFA reauthorization. The witnesses are: FDA commissioner Margaret Hamburg; …
Published on 1/27/2012
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The Bill & Melinda Gates Foundation committed $750 million to the Global Fund to Fight AIDS, Tuberculosis and Malaria. The announcement comes as the fund implements operational and oversight reforms following last year'…
Published on 1/26/2012
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The U.S. Patent and Trademark Office is seeking comments on independent second opinion genetic testing as part of a study required by patent reform legislation enacted last year. The America Invents Act requires the PTO…
Published on 1/26/2012
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President Obama on Wednesday released details of proposals announced in Tuesday's State of the Union address, including a permanent expanded R&D tax credit. Other proposals included doubling the tax deduction for …
Published on 1/25/2012
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The U.K.'s Human Genomics Strategy Group (HGSG) called on the government to produce a strategic document or white paper outlining a policy for the adoption of genomic technology in the National Health Service (NHS). The…
Published on 1/25/2012
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The board of the California Public Employees' Retirement System (CalPERS) re-elected Rob Feckner as president of the board for an eighth one-year term.
Published on 1/24/2012
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The Global Fund to Fight AIDS, Tuberculosis and Malaria said Michel Kazatchkine will step down as executive director by March 16. The fund appointed Gabriel Jaramillo as general manager, a post created to implement …
Published on 1/24/2012
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A Republican victory in the 2012 presidential election would lead to major changes in the Affordable Care Act, but not its complete repeal, former Minnesota GOP Sen. Norm Coleman predicted Sunday on BioCentury This Week…
Published on 1/23/2012
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Principal investigators from several laboratories said they will voluntarily stop research on the transmissibility of highly pathogenic avian influenza A (H5N1) in mammals for 60 days to allow for international …
Published on 1/20/2012
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Three of four value-based payment experiments reviewed by the Congressional Budget Office produced little or no savings for Medicare, according to a report released Wednesday. CBO suggested that substantial changes to …
Published on 1/19/2012
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The Biotechnology Industry Organization (BIO) hired Fritz Bittenbender as VP of alliance development and state government relations. He previously was VP of public affairs at Cephalon Inc., now part of Teva …
Published on 1/18/2012
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The California Institute for Regenerative Medicine's governing board approved a $40 million initiative to fund one or two Stem Cell Genomics Centers of Excellence in California. CIRM expects to publish applications in …
Published on 1/18/2012
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FDA said it did not submit a MDUFA reauthorization proposal to Congress by the statutory Jan. 15 deadline because the agency is still negotiating details of the plan with industry. The U.S. House Energy and Commerce …
Published on 1/18/2012