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Chronological Index of : Politics & Policy

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  • POLITICS & POLICY: C-Path starts DMD consortium

    The Critical Path Institute formed the Duchenne Regulatory Sciences Consortium (D-RSC) with founding members Santhera Pharmaceuticals Holding AG (SIX:SANN); PTC Therapeutics Inc. (NASDAQ:PTCT); and Brenda Wong of …

    Published on 8/3/2015
  • POLITICS & POLICY: FDA China head joins Pfizer

    Chris Hickey, formerly director of the China country office at FDA, joined Pfizer Inc. (NYSE:PFE) as senior director of public affairs for Asia-Pacific. FDA's new China office director is Leigh Verbois, who was director…

    Published on 7/31/2015
  • POLITICS & POLICY: FDA releases FY16 PDUFA fees

    FDA posted PDUFA fees for drug, biosimilar, and medical device marketing applications for FY16. Fees for drug applications containing clinical data will be $2.4 million, or $1.2 million without clinical data; last year'…

    Published on 7/31/2015
  • POLITICS & POLICY: FDA to hold patient-focused meeting on lung infections

    FDA will hold a public meeting on Oct. 15 to discuss non-tuberculous mycobacterial lung infections. The meeting is part of FDA's Patient-Focused Drug Development initiative, in which the agency is holding public …

    Published on 7/31/2015
  • POLITICS & POLICY: PhRMA names Ranganathan as head of advocacy

    The Pharmaceutical Research and Manufacturers of America named Rajesh Ranganathan VP of science and regulatory advocacy, effective Aug. 3. Ranganathan was director of the Office of Translational Research at the National…

    Published on 7/31/2015
  • POLITICS & POLICY: China FDA says sponsors must verify data in drug applications

    China FDA released a circular last week that imposes an Aug. 25 deadline for sponsors to inspect and validate clinical data in regulatory applications, or withdraw them without penalty.According to Sidley Austin LLP, a …

    Published on 7/29/2015
  • POLITICS & POLICY: Reps. show support for IPR exemptions

    Reps. Scott Peters (D-Calif.) and Ryan Costello (R-Pa.) led a bipartisan group of 80 Representatives who submitted a letter to U.S. House leadership supporting a carveout to the Innovation Act (H.R. 9) that would exempt…

    Published on 7/28/2015
  • POLITICS & POLICY: EMA revises accelerated assessment, conditional approval guidelines

    EMA issued draft revisions of its accelerated assessment and conditional approval guidelines.The accelerated assessment guideline now includes a more detailed explanation of how applicants may justify "major public …

    Published on 7/27/2015
  • POLITICS & POLICY: Docs decry high cost of cancer drugs

    More than 100 oncologists said that the high price of cancer drugs is negatively affecting the care of patients and called on patients to form a grassroots organization to advocate for more rational drug prices.The …

    Published on 7/24/2015
  • POLITICS & POLICY: CDER names Goldsmith associate director for rare diseases

    FDA's Center for Drug Evaluation and Research named Jonathan Goldsmith associate director of the Rare Diseases Program in its Office of New Drugs. Goldsmith, who joined the program last year, was its acting associate …

    Published on 7/23/2015
  • POLITICS & POLICY: FDA to hold meeting on REMS

    FDA will hold a public meeting Oct. 5-6 to discuss strategies to evaluate and minimize the burden of REMS on patient access and the healthcare delivery system. The meeting will focus on REMS with elements to assure safe…

    Published on 7/23/2015
  • POLITICS & POLICY: PCORI grants $142.5M to PCORnet

    The Patient-Centered Outcomes Research Institute approved $142.5 million in funding to support a second phase of development for the National Patient-Centered Clinical Research Network (PCORnet) over three years. …

    Published on 7/22/2015
  • POLITICS & POLICY: ICER gets $5.2M to fund drug pricing analyses

    The Institute for Clinical and Economic Review received a $5.2 million grant from the Laura and John Arnold Foundation and launched a new program to analyze cost effectiveness, comparative effectiveness, and budget …

    Published on 7/21/2015
  • POLITICS & POLICY: Senate passes clinical trials access bill

    The U.S. Senate passed the Ensuring Access to Clinical Trials Act of 2015 (S. 139), which would permanently allow people receiving Supplemental Security Income (SSI) and Medicaid benefits to participate in rare disease …

    Published on 7/17/2015
  • POLITICS & POLICY: Vote delayed on House patent bill

    Controversy over the biopharma industry's efforts to gain exemption from inter partes review (IPR) of granted patents, as well as disputes over other provisions, will delay a vote by the U.S. House of Representatives on…

    Published on 7/16/2015
  • POLITICS & POLICY: AHIP names Tavenner CEO

    Health insurance trade association America's Health Insurance Plans named Marilyn Tavenner president and CEO. Tavenner stepped down in February as administrator of CMS (see BioCentury Extra, Jan. 16).

    Published on 7/15/2015
  • POLITICS & POLICY: BIO, PhRMA outline PDUFA VI goals

    The Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America said Wednesday that they intend to use the PDUFA reauthorization process to advance three goals: improving the integration…

    Published on 7/15/2015
  • POLITICS & POLICY: Patient advocates discuss PDUFA VI aims

    At a public meeting Wednesday on PDUFA reauthorization, patient advocacy organizations called for expanding and adding rigor to FDA's efforts to integrate patient perspectives into regulatory decision-making. …

    Published on 7/15/2015
  • POLITICS & POLICY: Right to Try Act introduced in House

    Reps. Matt Salmon (R-Ariz.), Paul Gosar (R- Ariz.) and Marlin Stutzman (R- Ind.) introduced the Right to Try Act of 2015 into the U.S. House of Representatives. The bill seeks to prohibit federal agencies from limiting …

    Published on 7/14/2015
  • POLITICS & POLICY: CMS proposes Part B reimbursement rule for biosimilars

    CMS proposed a rule under which all biosimilars for a given reference product covered under Medicare Part B would be issued the same Healthcare Common Procedure Coding System (HCPCS) code, and would therefore be …

    Published on 7/10/2015
  • POLITICS & POLICY: House passes 21st Century Cures baton to Senate

    The U.S. House of Representatives voted 344-77 to pass the 21st Century Cures Act (H.R. 6) on Friday. The focus of the bill's supporters, including the Biotechnology Industry Organization (BIO), Pharmaceutical Research …

    Published on 7/10/2015
  • POLITICS & POLICY: IMI 2 commits EUR 95M to new call for proposals

    The EU's Innovative Medicines Initiative issued its fifth call for proposals for its IMI 2 program with a budget of EUR 95 million ($105.3 million). The program is soliciting proposals in six research areas, four of …

    Published on 7/9/2015
  • POLITICS & POLICY: White House nominates Slavitt as CMS administrator

    The White House nominated Andy Slavitt as administrator of the Centers for Medicare and Medicaid Services (CMS). He has been acting administrator since March, and was hired last year as principal deputy administrator of…

    Published on 7/9/2015
  • POLITICS & POLICY: House to vote on mandatory NIH funding

    The U.S. House Rules Committee voted Wednesday to allow the full House to vote on an amendment to the 21st Century Cures Act (H.R. 6) that would change proposed NIH and FDA funding increases from mandatory to …

    Published on 7/8/2015
  • POLITICS & POLICY: White House issues privacy guidelines for precision medicine

    The White House released an update Wednesday on the progress of its Precision Medicine Initiative (PMI) that included proposed privacy guidelines and a series of data-sharing partnerships.In draft guidelines, the White …

    Published on 7/8/2015

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