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  • POLITICS & POLICY: U.K. advances in mitochondrial replacement therapy

    The U.K.'s Human Fertilisation and Embryology Authority (HFEA) said it approved the use of mitochondrial donation, including pronuclear transfer or maternal spindle transfer, in certain circumstances. Newcastle …

    Published on 12/15/2016
  • POLITICS & POLICY: FDA extends window for off-label discussion

    FDA will extend the window for stakeholders to comment on issues related to off-label communications concerning FDA-approved medical products. The agency will now accept comments until April 10, 2017, extending the …

    Published on 12/14/2016
  • POLITICS & POLICY: SCOTUS declines to review Apotex biosimilar case

    The U.S. Supreme Court denied a petition from Apotex Inc. (Toronto, Ontario) asking it to review a lower court ruling that prevents the launch of a biosimilar until 180 days after FDA approval. The July decision by the …

    Published on 12/12/2016
  • POLITICS & POLICY: EMA defends Adaptive Pathways

    EMA defended its Adaptive Pathways program on Thursday amid concerns from payers and technology assessment bodies that it could lower the evidentiary standards for drug approvals. In 2014, EMA launched a pilot of …

    Published on 12/9/2016
  • POLITICS & POLICY: Solicitor general asks SCOTUS to review biosimilar ruling

    In an amicus brief filed to the U.S. Supreme Court, acting U.S. Solicitor General Ian Gershengorn recommended that the court review a lower court's decision preventing the launch of a biosimilar until 180 days after FDA…

    Published on 12/8/2016
  • POLITICS & POLICY: ARC submits amyloidosis draft guidance to FDA

    The Amyloidosis Research Consortium said it submitted draft guidance to FDA addressing drug development and clinical trial design for amyloid light chain (AL) amyloidosis. The patient group met with FDA, industry …

    Published on 12/7/2016
  • POLITICS & POLICY: FNIH releases final biomarker framework

    The Foundation for the National Institutes of Health (FNIH) released its framework outlining basic evidence required for biomarker qualification. The framework is designed to provide predictable and specific regulatory …

    Published on 12/7/2016
  • POLITICS & POLICY: Senate sends 21st Century Cures to Obama

    On Wednesday, the U.S. Senate passed the 21st Century Cures Act by a 94-5 vote. President Obama has endorsed the bill enthusiastically, and is expected to sign it soon.The result of two years of deliberations and debate…

    Published on 12/7/2016
  • POLITICS & POLICY: Two candidates on Trump short list for FDA commissioner

    President-elect Donald Trump's transition team has two candidates on the short list for FDA commissioner, a source on the team told BioCentury. In addition to Scott Gottlieb, a resident scholar at the American …

    Published on 12/7/2016
  • POLITICS & POLICY: Vermont releases drug pricing report

    In its first report since the passage of a new price transparency law, the Vermont Attorney General's office identified drugs with substantial increases in wholesale acquisition cost (WAC). The document named three …

    Published on 12/6/2016
  • POLITICS & POLICY: GOP leaders want Collins to stay at NIH helm

    The Republican chairs of U.S. Senate and House committees responsible for oversight of federal biomedical research have written a letter to President-elect Donald Trump urging him to retain Francis Collins as NIH …

    Published on 12/5/2016
  • POLITICS & POLICY: Jenkins stepping down at FDA's Office of New Drugs

    John Jenkins will step down as director of the Office of New Drugs (OND) at FDA's Center for Drug Evaluation and Research (CDER) on January 6, the agency announced Monday.During his 15 years leading OND, Jenkins has …

    Published on 12/5/2016
  • POLITICS & POLICY: Senate advancing 21st Century Cures Act

    The Senate Monday voted 85-13 to cut off debate on the 21st Century Cures Act. The procedural vote sets the stage for enactment of the legislation later this week. President Obama endorsed the bill strongly over the …

    Published on 12/5/2016
  • POLITICS & POLICY: ASCO releases oncology pathways criteria

    In newly released criteria describing high-quality clinical pathways in oncology, the American Society for Clinical Oncology emphasized the importance of transparent, clinically-driven pathways that reflect input from …

    Published on 12/1/2016
  • POLITICS & POLICY: House passes 21st Century Cures Act

    On Wednesday, the U.S. House of Representatives passed the 21st Century Cures Act (H.R. 34) by a 392-26 vote.White House Press Secretary Josh Earnest issued a statement calling the bill "critically important," and said …

    Published on 11/30/2016
  • POLITICS & POLICY: Japan considering annual drug price reviews

    Japan Prime Minister Shinzo Abe said the country needs to fundamentally rethink its policies for revising drug prices, including transparent policies that reflect drugs' cost effectiveness. The comments came last week …

    Published on 11/30/2016
  • POLITICS & POLICY: Trump to nominate Price, Verma

    President-elect Donald Trump said Tuesday he will nominate Rep. Tom Price (R-Ga.) as HHS secretary, and Seema Verma as CMS administrator. Price, who is chairman of the U.S. House Budget Committee, worked as an …

    Published on 11/29/2016
  • POLITICS & POLICY: White House endorses 21st Century Cures Act

    Politicians on both sides of Pennsylvania Avenue acted Tuesday to improve the odds of the U.S. Congress passing the 21st Century Cures Act. In a statement Tuesday evening, the White House said the Obama administration "…

    Published on 11/29/2016
  • POLITICS & POLICY: 21st Century Cures endgame

    The U.S. House of Representatives is slated to vote Wednesday on a revised version of the 21st Century Cures Act. If the House passes the bill, the Senate is likely to vote on it this week.The bill allocates $4.8 …

    Published on 11/28/2016
  • POLITICS & POLICY: BIO taps Booth for government affairs post

    BIO named Taylor Booth director of federal government affairs, spokesperson Dan Seaton told BioCentury. Booth replaces Jeanne Haggerty, who was promoted to SVP for federal government relations last year. Booth was chief…

    Published on 11/22/2016
  • POLITICS & POLICY: Schumer shucks Part B rule

    Incoming U.S. Senate Minority Leader Chuck Schumer (D-N.Y.) has asked the Obama administration to prevent CMS from issuing a final version of its Medicare Part B value-based drug purchasing demonstration project, …

    Published on 11/21/2016
  • POLITICS & POLICY: Sigal, Schilsky to lead Reagan-Udall board

    The non-profit Reagan-Udall Foundation said it elected Ellen Sigal as chairman and Richard Schilsky as vice chair of its board of directors. Sigal, who has been acting chair since 2015, is the founder of advocacy group …

    Published on 11/21/2016
  • POLITICS & POLICY: FDA plans 'new oversight' for LDTs in lieu of final guidance

    FDA plans to outline its view of "an appropriate risk-based approach" to regulating laboratory-developed tests in lieu of issuing final guidance on the matter, spokesperson Tara Goodin told BioCentury. In a statement, …

    Published on 11/18/2016
  • POLITICS & POLICY: FDA presents details on CAR T safety database

    At an EMA workshop on Wednesday, FDA presented details about how it is collecting data about chimeric antigen receptor T cell and T cell receptor (TCR) therapies for a safety database. FDA's Maura O'Leary said the …

    Published on 11/18/2016
  • POLITICS & POLICY: EMA updates first-in-human guidance

    In newly released draft guidance, EMA outlined revised strategies to identify and reduce risks in first-in-human testing, emphasizing the use of non-clinical pharmacokinetic, pharmacodynamic and toxicology data in …

    Published on 11/15/2016

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