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  • Goodwill hunting

    Commentary: Individual companies, not BIO, PhRMA, must address Turing outcry

    Commentary: Don't count on BIO or PhRMA to beat down the Turing outcry; goodwill with the public will be built one company at a time.

    Published on 9/28/2015
  • Table: A brief history

    Goodwill hunting A brief history Hillary Clinton's plan for lowering prescription drug costs aggregates ideas that have been staples of Democratic drug cost-containment legislation for over a decade. 
 Sources: …

    Published on 9/28/2015
  • Table: Cancer exclusions

    England's cancer problem Cancer exclusions Cancer medicines dropped by the Cancer Drugs Fund. Removed indications include those that have not been appraised by NICE as well as those rejected by the agency. (A) The…

    Published on 9/21/2015
  • England's cancer problem

    Why cancer drug access still in doubt in NHS England

    Cuts by NHS England's Cancer Drugs Fund are limiting patient options, and a system to replace it may not pay for drugs with proven efficacy.

    Published on 9/21/2015
  • Parting ways

    Innovators and biosimilars companies are turning to inter partes review for freedom to operate

    While trade associations are fighting for exemption from inter partes review, innovators are using the method to attack competitors' patents.

    Published on 9/14/2015
  • Box: Enlisting patients

    IPR battles Enlisting patients BIO has placed obtaining an inter partes review exemption for drug patents on the top of its legislative agenda, deploying CEOs to speak to members of Congress about patent reform …

    Published on 9/14/2015
  • Figure: Short skeptics

    IPR battles Short skeptics Compared with each company's historical averages, short interest has increased more than 20% in only three companies hedge fund manager Kyle Bass has targeted with petitions for inter …

    Published on 9/14/2015
  • Table: IPR tally

    IPR battles IPR tally Hedge funds have filed petitions for inter partes reviews (IPRs) of patents covering at least 16 drugs marketed in the U.S. by 14 public companies. Six declined in market value during the …

    Published on 9/14/2015
  • IPR battles

    Who's winning and who's losing at IPR so far

    So far, inter partes review hasn't been a drug patent killer, but BIO and PhRMA say it is a threat that must be slain.

    Published on 9/14/2015
  • Changing the subject

    23rd BioCentury Back to School Issue: Let patients show the way in drug development

    As 'value' becomes the rallying cry of payers, the 23rd Back to School essay says industry must help patients show the way throughout the product life cycle.

    Published on 9/7/2015
  • Box: Academy for advocacy

    Changing the subject Academy for advocacy The European Patients' Academy on Therapeutic Innovation is providing patients with formal training about drug development and regulatory and reimbursement decisions with …

    Published on 9/7/2015
  • Box: CDRH: Preferences in action

    Changing the subject CDRH: Preferences in action FDA's Center for Devices and Radiological Health established an important precedent when it used patient preference data to approve the Maestro Rechargeable System …

    Published on 9/7/2015
  • Box: Chartered territory

    Changing the subject Chartered territory UCB Group and the Parkinson's Disease Foundation are developing a charter to align their expectations, goals and work plan for a new company-patient collaboration, which …

    Published on 9/7/2015
  • Box: Convincing payers

    Changing the subject Convincing payers Anthem Inc.'s HealthCore Inc. subsidiary has been working directly with patients for more than eight years to get feedback on endpoints that are important to them and to …

    Published on 9/7/2015
  • Box: Founding framers

    Changing the subject Founding framers Biopharma companies and patient groups have launched the Patient-Focused Medicine Development consortium to develop best practices for patient involvement in drug development.…

    Published on 9/7/2015
  • Box: J&J's CompACt

    Changing the subject J&J's CompACt Johnson & Johnson and New York UniversitySchool of Medicine are testing a model for evaluating compassionate access requests via an independent third party. The medical school …

    Published on 9/7/2015
  • Box: Legal-ease

    Changing the subject Legal-ease While FDA has endorsed patient engagement in both word and deed through its patient-focused drug development meetings, many drug companies say they do not feel safe engaging with …

    Published on 9/7/2015
  • Box: Patient focus 2.0

    Changing the subject Patient focus 2.0 FDA, biopharma companies and patient groups agree PDUFA VI should expand on the patient-focused drug development concept that was introduced in PDUFA V. The goal is to add …

    Published on 9/7/2015
  • Box: Patient power in Duchenne

    Changing the subject Patient power in Duchenne Parent Project Muscular Dystrophy provided a powerful demonstration of how a well-informed and sophisticated patient advocacy group can transform drug development in …

    Published on 9/7/2015
  • Box: Paying attention

    Changing the subject Paying attention The Canadian Agency for Drugs and Technologies in Health formally includes patient advocacy groups in health technology assessments and has begun incorporating their input …

    Published on 9/7/2015
  • Box: Reducing burdens

    Changing the subject Reducing burdens Several drug developers are evaluating ways to lower the burden of participating in clinical trials, including reducing the need for site visits and eliminating the risk that …

    Published on 9/7/2015
  • Box: Rules of engagement

    Changing the subject Rules of engagement UCB Group has developed a framework to ensure its employees engage with patients in ways that are both legally compliant and respectful of a patient's condition and privacy…

    Published on 9/7/2015
  • Figure: Applying preference research

    Changing the subject Applying preference research According to a draft guidance from FDA's Center for Devices and Radiological Health, patient preference research may be used throughout the product life cycle. …

    Published on 9/7/2015
  • Figure: Lack of participation

    Changing the subject Lack of participation According to a survey conducted between the end of 2010 and the fall of 2011 by the European Patients' Forum, just under half of the 40 HTA agencies that responded were …

    Published on 9/7/2015
  • Table: Pain points

    Changing the subject Pain points A sample of FDA's patient-focused drug development meetings reveals cases where patients want different endpoints, data or trial designs than companies and regulators use. Sources:…

    Published on 9/7/2015

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