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Chronological Index of : Politics and Policy

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  • Perplexit

    Brexit could cut off EMA from U.K. expertise

    Brexit would slash or eliminate MHRA's role in EMA, drying up one of the agency's biggest pools of scientific and regulatory expertise.

    Published on 7/11/2016
  • Box: Moving authority

    Perplexit Moving authority A British exit from the EU could make it necessary to shift marketing authorizations (MAs) from the U.K. to the continent, creating a legal headache for multinational pharmas, and …

    Published on 7/11/2016
  • Is that clear?

    How Vermont's drug price transparency law could pave the way for price controls

    Vermont's drug price transparency law is part of a national strategy that is aiming for price controls.

    Published on 6/27/2016
  • Box: PhRMA explains

    Is that clear? PhRMA explains In March 30 testimony about Vermont's drug price transparency law, PhRMA Assistant General Counsel John Murphy discussed the industry's perspective on drug pricing. The PhRMA …

    Published on 6/27/2016
  • Figure: Transparency provisions

    Is that clear? Transparency provisions Vermont is the first state to enact a drug price transparency law, but at least a dozen were introduced in state legislatures during 2015-16. Some of them have expired …

    Published on 6/27/2016
  • Box: Coordinated campaign

    Plan B for Part B? Coordinated campaign In addition to the advocacy efforts of BIO and PhRMA, at least 38 pharmaceutical companies have lobbied Congress in 2016 about Medicare, including 22 that specified that …

    Published on 5/23/2016
  • Plan B for Part B?

    Why biopharma, physicians are waging war against CMS proposal

    Pharma's effort to force CMS to withdraw its Part B value-based drug purchasing model is a test of drug company political clout.

    Published on 5/23/2016
  • Figure: Sourcing IPRs

    SCOTUS to the rescue? Sourcing IPRs While the media and investors have focused on inter partes review petitions filed by hedge funds, the vast majority of drug patent IPR challenges have been launched by generic …

    Published on 4/25/2016
  • Table: Hedging on IPRs

    SCOTUS to the rescue? Hedging on IPRs Hedge fund manager Kyle Bass put the inter partes review process on biotech investors' radar screens. Entities associated with Bass have convinced the U.S. Patent and …

    Published on 4/25/2016
  • SCOTUS to the rescue?

    What's at stake as Supreme Court hears Cuozzo inter partes review case

    The biopharma industry's only hope for near-term relief from IPR patent challenges is a Supreme Court case to be argued this week.

    Published on 4/25/2016
  • Can 'Cures' be cured?

    Assessing the prospects for Senate's 21st Century Cures bill

    Any 21st Century Cures bill that can get through Congress will not come close to radically transforming drug discovery or dramatically accelerating cures.

    Published on 4/18/2016
  • Box: Biosimilars battles

    Can 'Cures' be cured? Biosimilars battles An arcane phrase inserted into part of the Senate Cures legislative package has set off alarm bells at some biosimilar companies and in the offices of the U.S. …

    Published on 4/18/2016
  • Box: Concentrating power at NIH

    Can 'Cures' be cured? Concentrating power at NIH The NIH provisions of the House and Senate's Cures legislation seek to make NIH more accountable, but they do this by aggregating more money and power in the hands …

    Published on 4/18/2016
  • Figure: 21st Century Cures

    Can 'Cures' be cured? 21st Century Cures The U.S. House of Representatives voted 344 -77 on July 10, 2015 to pass the 21st Century Cures Act (H.R. 6). Selected provisions of the 362-page bill follow, some of which…

    Published on 4/18/2016
  • Table: Senate innovation agenda

    Can 'Cures' be cured? Senate innovation agenda The Senate Health, Education, Labor and Pensions (HELP) Committee has passed a series of bills that Chair Lamar Alexander (R-Tenn.) intends to bundle into a single …

    Published on 4/18/2016
  • Editors' Commentary: Save the baby

    Why biopharma should fight to create a true value-based experiment at CMS, not kill it

    CMS should not go forward with its flawed value-based payment experiment. But the stakeholders need to fix it, not to kill it outright.

    Published on 3/28/2016
  • Value demonstration

    Hurdles CMS must clear to test value-based schemes for Part B drugs

    Oncologists, hospitals, drug companies and Republicans are trying to kill CMS's proposal to test value-based schemes for Part B drugs.

    Published on 3/14/2016
  • Table: Part B targets

    Value demonstration Part B targets CMS is proposing a nationwide, mandatory "demonstration project" to assess whether and how various changes in Part B drug reimbursement policies would affect costs and clinical …

    Published on 3/14/2016
  • Table: Putting value to the test

    Value demonstration Putting value to the test CMS is proposing a nationwide controlled experiment to test alternative systems for paying for drugs provided under the Part B Medicare benefit, which includes drugs …

    Published on 3/14/2016
  • Table: PDUFA VI at a glance

    Fixing potholes with PDUFA PDUFA VI at a glance FDA, PhRMA and BIO are reviewing a draft PDUFA VI goals letter that spells out the industry's funding commitments and associated FDA objectives. According to …

    Published on 2/22/2016
  • Fixing potholes with PDUFA

    PDUFA VI goals include improving FDA hiring, drug development tools

    Industry and FDA have agreed on terms for PDUFA VI. The hard part starts in the fall when the deal is handed to Congress.

    Published on 2/22/2016
  • Nature won't wait

    Fast start for Zika virus vaccines

    Lessons learned from Ebola haven't been put into practice, but a crash program is already under way for the next crisis, Zika.

    Published on 2/15/2016
  • Crushing need

    It is past time to apply lessons from infectious disease outbreaks

    The threat, and needed responses, from emerging pathogens have been obvious for decades. Framing the threat as a security issue may help get some action.

    Published on 2/15/2016
  • Box: Stalled on the Nile

    Nature won't wait Stalled on the Nile In 1999, when West Nile virus was first detected in the U.S., Americans panicked. The flavivirus, transmitted by mosquitoes, causes severe symptoms including neurological …

    Published on 2/15/2016
  • Table: Racing to beat Zika

    Nature won't wait Racing to beat Zika Since the World Health Organization assigned its highest threat level to the Zika virus, multiple companies and institutions have announced plans to develop vaccines against …

    Published on 2/15/2016

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