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Chronological Index of : Politics & Policy

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  • POLITICS & POLICY: Woodcock: Breakthrough designation mostly about efficacy

    FDA awards or denies breakthrough designation requests primarily based on convincing clinical evidence of substantial efficacy or lack thereof, Janet Woodcock said Friday at a conference organized by Friends of Cancer …

    Published on 11/21/2014
  • POLITICS & POLICY: EMA updates conflict-of-interest policy

    EMA published its revised conflict-of-interest policy, clarifying which levels of conflict are tied to certain restrictions upon who can serve as experts or scientific committee members.The new policy precludes in …

    Published on 11/20/2014
  • POLITICS & POLICY: IMS: Global drug spending peak in 2014

    In its annual "Global Outlook for Medicines" report published Thursday, the IMS Institute for Healthcare Informatics said it expects global drug spending to reach about $1.3 trillion by 2018 from $989 billion in 2013. …

    Published on 11/20/2014
  • POLITICS & POLICY: U.K. launches review to speed patient access

    The U.K. government said it will launch a review of its drug, device and diagnostics development process in order to speed up patient access to new therapies.The Innovative Medicines and MedTech Review will explore ways…

    Published on 11/20/2014
  • POLITICS & POLICY: HHS, NIH want to expand ClinicalTrials.gov mandates

    HHS and NIH on Wednesday proposed new rules governing the transparency of clinical trials that could more than double the number of submissions of study results to ClinicalTrials.gov.The agencies issued a notice of …

    Published on 11/19/2014
  • POLITICS & POLICY: Pallone defeats Eshoo for E&C seat

    Rep. Frank Pallone (D-N.J.) defeated Rep.Anna Eshoo (D-Calif.) in a 100-90 vote to replace Rep. Henry Waxman (D-Calif.) as the ranking Democrat of the House Energy & Commerce Committee. E&C has oversight authority for …

    Published on 11/19/2014
  • POLITICS & POLICY: HRSA expects 340B guidance next year

    HHS's Health Resources and Services Administration said that it will not issue draft guidance on its 340B drug discounting program until 2015. The draft was expected in June. The 340B program requires manufacturers to …

    Published on 11/18/2014
  • POLITICS & POLICY: Tufts: Average drug development cost now $2.6B

    The Tufts Center for the Study of Drug Development has concluded the average cost of developing an approved therapeutic has reached $2.6 billion. The figure, released on Tuesday, includes $1.4 billion in average out-of-…

    Published on 11/18/2014
  • POLITICS & POLICY: ASCO recommends Medicaid reforms

    The Health Disparities Committee of the American Society of Clinical Oncology (ASCO) released a policy statement outlining nine recommendations for Medicaid reform designed to increase access to high-quality cancer care…

    Published on 11/17/2014
  • POLITICS & POLICY: FDA issues draft guidance on pediatric Priority Review vouchers

    FDA is seeking comments on its draft guidance entitled "Rare Pediatric Disease Priority Review Voucher," which outlines procedures for obtaining and using Priority Review vouchers issued for rare pediatric diseases. …

    Published on 11/17/2014
  • POLITICS & POLICY: FDA to add staff in China

    FDA Commissioner Margaret Hamburg will meet with Chinese officials this week to discuss the agency's staffing needs in China.Agency spokesperson Christopher Kelly said increased staffing in China "will further …

    Published on 11/17/2014
  • POLITICS & POLICY: Industry tracks

    The U.K. BioIndustry Association hired Nick Gardiner as COO. Gardiner joined the BIA last month from Lab21 Ltd., where he led the clinical laboratory division following the company's acquisition by Novacyt S.A. (…

    Published on 11/14/2014
  • POLITICS & POLICY: ABPI responds to CDF's drug re-evaluation process

    The Association of the British Pharmaceutical Industry (ABPI) said it is "disappointed" by a newly released document from NHS England's Cancer Drugs Fund (CDF) describing its methods of re-evaluating its list of covered…

    Published on 11/13/2014
  • POLITICS & POLICY: EU Ombudsman grills EMA on AbbVie settlement

    EU Ombudsman Emily O'Reilly is scrutinizing EMA's settlement with AbbVie Inc. (NYSE:ABBV), in which the agency redacted information from clinical study reports about AbbVie's autoimmune drug Humira adalimumab. According…

    Published on 11/12/2014
  • POLITICS & POLICY: FDA's Gutierrez clarifies LDT review timelines

    FDA's Alberto Gutierrez clarified the agency's timelines as it institutes a regulatory approach for laboratory-developed tests. Gutierrez shared with BioCentury his recent presentation at the Clinical Laboratory …

    Published on 11/12/2014
  • POLITICS & POLICY: C-Path, IMI to benchmark PPP performance

    The Critical Path Institute (C-Path) and EU's Innovative Medicines Initiative (IMI) will host their second joint conference on Dec. 3 to discuss the benchmarks for public-private partnerships in biopharmaceutical …

    Published on 11/7/2014
  • POLITICS & POLICY: SCOTUS will hear ACA subsidy case

    The U.S. Supreme Court agreed to hear King v. Burwell this term to decide whether the Internal Revenue Service can extend tax credits to people who purchase health insurance through federally-run exchanges. At issue is …

    Published on 11/7/2014
  • POLITICS & POLICY: Arizona voters pass right-to-try measure

    Arizona voters passed Proposition 303, a right-to-try ballot measure that gives terminally ill patients access to experimental therapies not yet approved by FDA, with 78.3% of the vote.The measure says an eligible …

    Published on 11/6/2014
  • POLITICS & POLICY: FDA unlikely to pull conventional opioids

    Opioid abuse-deterrence technology is in its "infancy" and FDA is unlikely to remove opioids that lack abuse-deterrence features from the market soon, Janet Woodcock, director of FDA's Center for Drug Evaluation and …

    Published on 11/6/2014
  • POLITICS & POLICY: Valeant and Pershing Square may vote

    The U.S. District Court for the Central District of California ruled that activist Pershing Square Capital and Valeant Pharmaceuticals International Inc. (NYSE:VRX; TSX:VRX) may vote shares of Allergan Inc. (NYSE:AGN) …

    Published on 11/5/2014
  • POLITICS & POLICY: FDA asks where to add patient perspectives

    FDA is looking to expand its patient-driven drug development process by inviting stakeholders to weigh in on "strategies to solicit the views of patients during the medical product development process and consider the …

    Published on 11/3/2014
  • POLITICS & POLICY: MHRA names Rawlins chairman

    The U.K.'s Medicine and Healthcare Products Regulatory Agency (MHRA) named Michael Rawlins chairman for a three-year appointment effective Dec. 1.He succeeds Gordon Duff, who said he would step down after he was elected…

    Published on 11/3/2014
  • POLITICS & POLICY: Patient groups, PhRMA to huddle on expanded access

    Four patient advocacy organizations and the Pharmaceutical Research and Manufacturers of America will discuss compassionate use on Dec. 10 at an invitation-only workshop in Washington entitled "Role of Investigational …

    Published on 11/3/2014
  • POLITICS & POLICY: Regulator tracks

    Joseph Griffin joined regulatory consulting firm Greenleaf Health LLC as EVP of drug and biological drug products. He was associate director for policy development in the Office of Medical Policy at FDA's Center for …

    Published on 10/31/2014
  • POLITICS & POLICY: Veloxis respectfully begs to differ with FDA

    Veloxis Pharmaceuticals A/S (CSE:VELO) plunged DKK0.63 (31%) to DKK1.40 on Friday after the company said FDA's tentative approval of immunosuppressant Envarsus XR tacrolimus will not become finalized until exclusivity …

    Published on 10/31/2014

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