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Chronological Index of : Politics & Policy

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  • POLITICS & POLICY: HELP takes piecemeal approach with innovation bills

    The U.S. Senate Health, Education, Labor and Pensions committee will take an a la carte approach to new companion legislation to the 21st Century Cures Act, rather than bundling provisions into a single innovation bill.…

    Published on 1/19/2016
  • POLITICS & POLICY: Holiday notice

    BioCentury Extra wil not publish Monday, Jan. 18, in observance of the Martin Luther King, Jr., holiday in the U.S. BioCentury Extra will resume publishing on Tuesday, Jan. 19.

    Published on 1/15/2016
  • POLITICS & POLICY: Supreme Court to rule on IPR standards

    The U.S. Supreme Court agreed Friday to hear a case that could address two of the drug industry's key complaints about the inter partes review system. In Cuozzo Speed Technologies LLC v. Lee, the Supreme Court will …

    Published on 1/15/2016
  • POLITICS & POLICY: FASEB issues reproducibility recommendations

    The Federation of American Societies for Experimental Biology (FASEB) issued Enhancing Research Reproducibility, a set of recommendations that give guidance on the more rigorous reproducibility requirements NIH will …

    Published on 1/14/2016
  • POLITICS & POLICY: FDA to discuss drug-induced liver injury

    FDA will hold a public meeting March 23 for stakeholders to discuss ways of measuring, evaluating and acting upon drug-induced liver injury and dysfunction in clinical trials. Critical Path Institute (C-Path) will co-…

    Published on 1/14/2016
  • POLITICS & POLICY: GAO finds postmarket data lacking for expedited approvals

    In a report released Thursday, the U.S. Government Accountability Office concluded that FDA "lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket …

    Published on 1/14/2016
  • POLITICS & POLICY: NIH asked to march in on Xtandi's price

    Although NIH has explicitly stated that price is not a valid justification for it to use march-in rights for patents, two advocacy groups have requested that U.S. government agencies exercise march-in rights for …

    Published on 1/14/2016
  • POLITICS & POLICY: NIH launches sequencing center

    NIH's National Human Genome Research Institute (NHGRI) launched the Centers for Common Disease Genomics (CCDG), a new genomic sequencing and analysis center to investigate mutations associated with common diseases. NIH …

    Published on 1/14/2016
  • POLITICS & POLICY: U.K. to decide on gene editing in human embryos

    The U.K.'s Human Fertilisation & Embryology Authority (HFAE) met Thursday to discuss an application from the Francis Crick Institute to use genome editing in human embryos. A Crick spokesperson told BioCentury that a …

    Published on 1/14/2016
  • POLITICS & POLICY: FDA to discuss genetic test results

    FDA will hold a public workshop on March 2 to discuss patient and provider perspectives on receiving genetic test results. The agency hopes to clarify what information patients and providers prefer to receive, including…

    Published on 1/13/2016
  • POLITICS & POLICY: NAM proposes global pandemic R&D effort

    The U.S. National Academy of Medicine released a report Wednesday recommending that the World Health Organization establish an independent Pandemic Product Development Committee (PPDC) in 2016 that would accelerate R&D …

    Published on 1/13/2016
  • POLITICS & POLICY: Obama asks Biden to lead cancer initiative

    In his State of the Union address Tuesday, President Obama called on Vice President Joe Biden to lead a "moonshot" effort to cure cancer. In a blog post, Biden said he would work to increase public and private funding …

    Published on 1/13/2016
  • POLITICS & POLICY: ASCO voices concerns about treatment pathways

    The American Society of Clinical Oncology issued a policy statement on Tuesday voicing concerns that clinical treatment pathways for cancer are "being developed and implemented today in a manner that may impede delivery…

    Published on 1/12/2016
  • POLITICS & POLICY: Coalition aims for cancer MoonShot

    Stakeholders including biopharma companies, academic research centers, community oncologists, payer Independence Blue Cross (Philadelphia, Pa.) and Bank of America Corp. (NYSE:BAC) launched the MoonShot 2020 initiative …

    Published on 1/12/2016
  • POLITICS & POLICY: FDA seeking comment on clinical outcome assessments

    FDA said it is accepting comments and recommendations on its clinical outcome assessment compendium. A pilot version will be available online Wednesday, and the agency's deadline for feedback is March 13.FDA said at a …

    Published on 1/12/2016
  • POLITICS & POLICY: BIO names Durham health policy leader

    The Biotechnology Innovation Organization hired Dan Durham as EVP and the leader of its health policy section, effective Jan. 18. He will replace interim policy head Kay Holcombe, who will return to her role as SVP of …

    Published on 1/7/2016
  • POLITICS & POLICY: HHS drafting prescription drug pricing report

    The omnibus spending bill signed into law by President Obama on Dec. 18 included a little-noticed provision directing HHS to create a report on prescription drug prices that is intended to influence political debates on…

    Published on 1/5/2016
  • POLITICS & POLICY: BIO changes name

    The Biotechnology Industry Organization changed its name to the Biotechnology Innovation Organization. The group, which announced plans in June to change its name, intends to continue using the "BIO" acronym.

    Published on 1/4/2016
  • POLITICS & POLICY: FDA invites patient groups to lead meetings

    FDA formally invited patient groups to organize externally led meetings modeled on the agency's own patient-focused drug development (PFDD) initiative. In a Federal Register notice, the agency noted "growing external …

    Published on 1/4/2016
  • POLITICS & POLICY: Orphan drugs push approvals to new high in 2015

    FDA reported Monday that it approved 45 new drugs and biologics in 2015. A record high of 21 Orphan drugs, or 47% of the total, gained approval.The overall tally is FDA's highest since 1996, when enactment of the …

    Published on 1/4/2016
  • POLITICS & POLICY: Senate's HELP schedules Califf vote

    The U.S. Senate Health, Education, Labor and Pensions Committee said it will vote Jan. 12 on the nomination of Robert Califf as FDA commissioner. If passed, Califf's nomination will advance to the full Senate. The …

    Published on 1/4/2016
  • POLITICS & POLICY: ASCO elects Johnson president

    The American Society of Clinical Oncology elected Bruce Johnson ASCO president for the 2017-18 term. He will take office as president-elect at the June 2016 ASCO meeting.Johnson is chief clinical research officer and …

    Published on 12/23/2015
  • POLITICS & POLICY: Clinton proposes AD funding boost

    Hillary Clinton unveiled a proposal to dedicate $2 billion annually for Alzheimer's disease research. The plan's goals include developing therapies to prevent and treat AD, as well as "making a cure possible," by 2025. …

    Published on 12/23/2015
  • POLITICS & POLICY: Holiday notice

    BioCentury Extra will not publish Thursday, Dec. 24, or Friday, Dec. 25, in observance of the Christmas holiday. BioCentury Extra will resume publishing on Monday, Dec. 28.

    Published on 12/23/2015
  • POLITICS & POLICY: CMS launches Medicare drug spending database

    CMS released its Medicare Drug Spending Dashboard, which details prescription drug spending through Medicare Part B and Part D. The sortable database includes 80 drugs that can be ranked based on total annual cost, …

    Published on 12/22/2015

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