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Chronological Index of : Politics & Policy

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  • 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
  • POLITICS & POLICY: EMA issues biosimilar development guidance

    EMA issued final guidance outlining general principles for developing biosimilars in the EU with a handful of changes from draft guidance issued in May 2013 (see BioCentury Extra, May 2, 2013).The final guidance adds …

    Published on 10/29/2014
  • POLITICS & POLICY: Rep. McCaul outlines compassionate access bill

    Rep. Michael McCaul (R-Texas) plans to introduce compassionate access legislation that would impose new requirements on drug developers and establish rights for patients. McCaul summarized the legislation and his …

    Published on 10/29/2014
  • POLITICS & POLICY: Senators seek to incentivize Ebola research

    Sens. Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.) plan to introduce a bill that would add Ebola to the list of eligible diseases under FDA's Priority Review voucher program for tropical diseases. Upon FDA approval…

    Published on 10/29/2014
  • 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of clinical trial results, citing analysis showing that "a significant proportion of healthcare research remains unpublished," and its…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

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