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Chronological Index of : Politics & Policy

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  • POLITICS & POLICY: WHO wants trial disclosure deadlines

    The World Health Organization is calling for a strict timeline for public disclosure of clinical trial results, citing analysis showing that "a significant proportion of healthcare research remains unpublished," and its…

    Published on 10/23/2014
  • POLITICS & POLICY: FDA backs further study of kidney biomarkers

    FDA issued its first Letter of Support for two kidney biomarkers identified by the Predictive Safety Testing Consortium (PSTC) of the Critical Path Institute (C-Path).Elevated levels of the two biomarkers, osteopontin (…

    Published on 10/21/2014
  • POLITICS & POLICY: U.S. calls pathogen research timeout

    The White House Office of Science and Technology Policy (OSTP) and HHS announced the U.S. government has halted funding for "gain of function" (GOF) research that could increase the pathogenicity or respiratory …

    Published on 10/20/2014
  • POLITICS & POLICY: Looking ahead at PTO

    President Obama's nomination of Michelle Lee as director of the U.S. Patent and Trademark Office marks a victory of Silicon Valley tech interests over the U.S. biopharmaceutical industry in their battle for control over…

    Published on 10/17/2014
  • POLITICS & POLICY: CDER restructures for product quality initiative

    Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, announced that CDER will restructure to implement her plan to modernize drug quality oversight through a "super-office" that will cover all …

    Published on 10/16/2014
  • POLITICS & POLICY: White House elevating Google veteran at PTO

    The Obama administration continued to reinforce its ties to Silicon Valley with the nomination of Michelle Lee to be director of the U.S. Patent and Trademark Office. Lee, who also would be under secretary for …

    Published on 10/16/2014
  • POLITICS & POLICY: SCOTUS challenges on Teva patent case

    U.S. Supreme Court justices on Wednesday voiced skepticism about arguments from both sides in the petition by Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to overturn an appeals court decision that invalidated the …

    Published on 10/15/2014
  • POLITICS & POLICY: USTR launches review of IPR in India

    The Office of the U.S. Trade Representative (USTR) announced its planned review of intellectual property rights (IPR) in India. The review, promised in April when USTR published its "2014 Special 301 Report," noted …

    Published on 10/13/2014
  • POLITICS & POLICY: FDA finalizes 5-year exclusivity for NCE combos

    FDA issued final guidance under which it will grant five years of exclusivity to fixed-dose combination products that have at least one new active moiety. Previously, FDA interpreted its exclusivity regulations to mean …

    Published on 10/10/2014
  • POLITICS & POLICY: Exchange pharmacies using specialty drugs more often

    Patients enrolled in public health exchanges under the Affordable Care Act are using more generics than patients in traditional health plans, but also are prescribed a larger proportion of specialty drugs, especially …

    Published on 10/9/2014
  • POLITICS & POLICY: Tufts finds value for money in specialty drugs

    A study published in Health Affairs suggests that despite their higher costs, specialty drugs can offer "reasonable value for money" compared to traditional drugs, although the treatment gains from specialty treatments …

    Published on 10/8/2014
  • POLITICS & POLICY: Biosimilar workflow growing at CDER

    FDA's Center for Drug Evaluation and Research on Tuesday told BioCentury it has received 78 requests for initial meetings to discuss biosimilar development programs for 14 different reference products. CDER also said it…

    Published on 10/7/2014
  • POLITICS & POLICY: FDA issues new patient-focused nominations

    FDA is seeking public comments on disease areas it has nominated for future meetings of its patient-focused drug development (PFDD) initiative. PFDD aims to obtain patient perspectives on specific diseases and …

    Published on 10/7/2014
  • POLITICS & POLICY: FDA to review REMS for Soliris

    FDA's Drug Safety and Risk Management Advisory Committee (DSaRM) will meet on Nov. 18 to discuss the REMS for Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN). The committee is seeking public …

    Published on 10/7/2014
  • POLITICS & POLICY: Scotland puts industry rebates back into medicines fund

    The Scottish government launched the L40 million ($63.9 million) New Medicines Fund to provide NHS Scotland patients with greater access to drugs for rare diseases and end of life conditions. The fund was established …

    Published on 10/7/2014
  • POLITICS & POLICY: FDA calls for new opioids standard

    In FDA's continuing response to critics of the agency's approval of Zohydro ER hydrocodone bitartrate, CDER Director Janet Woodcock and colleagues have called on states, medical boards and clinicians to impose …

    Published on 10/6/2014
  • POLITICS & POLICY: FDA final guidance on pCR in neoadjuvant breast cancer

    FDA published its final guidance on the use of pathologic complete response (pCR) as a surrogate endpoint for accelerated approval of neoadjuvant therapy for high-risk early stage breast cancer. The neoadjuvant setting,…

    Published on 10/6/2014
  • POLITICS & POLICY: Bach proposes indication-specific prices

    Peter Bach, director of Memorial Sloan-Kettering's Center for Health Policy and Outcomes, advocated creating an indication-based pricing system for cancer drugs in a commentary published in the Oct. 3 Journal of the …

    Published on 10/3/2014
  • POLITICS & POLICY: GPhA disputes lawmakers on generic prices

    The Generic Pharmaceutical Association (GPhA) challenged data cited by members of Congress who are launching an investigation into generic drug prices.Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) …

    Published on 10/3/2014
  • POLITICS & POLICY: FDA panel to review sNDA for Vertex's Kalydeco

    FDA's Pulmonary-Allergy Drugs Advisory Committee will meet on Oct. 21 to review an sNDA from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) for use of Kalydeco ivacaftor oral tablets to treat cystic fibrosis patients aged 18…

    Published on 10/2/2014
  • POLITICS & POLICY: New EMA guidance on pediatric trials, Crohn's endpoints

    The European Medicines Agency released a guideline for pediatric investigation plans (PIPs), which revises its 2008 guideline specifying drug developer obligations to test new medicinal products in children. The new …

    Published on 10/2/2014
  • POLITICS & POLICY: CMS says payments database is "first wave"

    CMS released what it called its "first wave" of its Open Payments database, which details consulting fees, research grants, travel reimbursements, and "other" gifts healthcare companies provided to physicians and …

    Published on 9/30/2014
  • POLITICS & POLICY: FDA starts clock on LDT regulation

    On Tuesday, FDA released two draft guidance documents that outline the agency's plans for regulating laboratory-developed tests (LDTs). The draft guidance is largely in line with documents pre-released in July (see …

    Published on 9/30/2014
  • POLITICS & POLICY: NIAID funds development of new vaccine adjuvants

    NIH's National Institute of Allergy and Infectious Diseases awarded five-year contracts to seven research institutions developing new vaccine adjuvants that boost responses by activating the adaptive immune system. The …

    Published on 9/30/2014
  • POLITICS & POLICY: NIH awards $46M in BRAIN initiative grants

    NIH issued $46 million in grants to support 58 research projects that are part of the Brain Research through Application of Innovative Neurotechnologies (BRAIN) initiative. Most of the grants are for new neuroscience …

    Published on 9/30/2014

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