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Chronological Index of : Strategy

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    Changing the subject Applying preference research According to a draft guidance from FDA's Center for Devices and Radiological Health, patient preference research may be used throughout the product life cycle.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

    Changing the subject Preference methods The Medical Device Innovation Consortium (MDIC) and FDA's Center for Devices and Radiological Health both describe a variety of patient-preference research methods. There is…

    Published on 9/7/2015
  • Table: Unmet need, indeed

    Changing the subject Unmet need, indeed Patient comments from a sampling of FDA's patient-focused drug development meetings have highlighted symptoms that are not adequately addressed by marketed drugs or most …

    Published on 9/7/2015
  • Green light for GeneWeave

    How GeneWeave technology fits Roche's plans to combat antimicrobial resistance

    Roche is buying GeneWeave's Smarticles technology to find the right drug for the bug in time to guide infectious disease treatment.

    Published on 8/24/2015
  • Guest Commentary: Overvaluing speed to market

    Why Priority Review vouchers might not be worth it

    Why Roger Longman says the market bubble in Priority Review vouchers signals the dramatic overvaluation of getting to market first.

    Published on 8/24/2015
  • Shifting MS spending

    How the multiple sclerosis market slowdown will affect new entrants

    Payers have finally found the means and will to combat MS spending increases and refocus negotiations on value metrics.

    Published on 8/17/2015
  • Figure: Inflection point?

    Shifting MS spending Inflection point? U.S. average wholesale price (AWP) data for MS drugs show double-digit growth rates are giving way to more moderate trajectories. The average compound annual growth rate (…

    Published on 8/17/2015
  • Figure: Slowing growth

    Shifting MS spending Slowing growth Aggregate sales of multiple sclerosis drugs from four major players have stalled over the last few quarters, largely due to the recent slowdown in products from Biogen Inc. (…

    Published on 8/17/2015
  • Table: Up next in MS

    Shifting MS spending Up next in MS At least eight new compounds are in Phase III or registration to treat multiple sclerosis, led by Zinbryta daclizumab. AbbVie Inc. (NYSE:ABBV) said it expects regulatory …

    Published on 8/17/2015
  • Figure: Exelixis' roller coaster

    Capitalizing on Cometriq Exelixis' roller coaster Exelixis Inc. (NASDAQ:EXEL) has seen its stock go on a wild ride since 2010, when it restructured twice and narrowed its focus to Cometriq cabozantinib for cancer.…

    Published on 8/10/2015
  • Capitalizing on Cometriq

    How Exelixis engineered revival by focusing on Cometriq

    After a drastic restructuring and multiple clinical setbacks, Exelixis' singular focus on Cometriq finally may pay dividends.

    Published on 8/10/2015
  • Isis executes

    How new strategic partnership with AZ fits into Isis' partnering strategy

    Isis has planted its second expansive strategic relationship, joining with AZ to go where small molecules and biologics don't work.

    Published on 8/10/2015
  • Figure: Increasingly rare

    Shire's M&A stepping stone Increasingly rare The addition of clinical compounds from Baxalta Inc. (NYSE:BXLT) would greatly expand the rare diseases pipeline at Shire plc (LSE:SHP; NASDAQ:SHPG), adding 15 …

    Published on 8/10/2015
  • Shire's M&A stepping stone

    Totting up the leverage, risks in Shire's pursuit of Baxalta

    Baxalta may provide Shire with firepower to pursue more rare disease M&A, but a lot has to go right to reach $20B in revenue by 2020.

    Published on 8/10/2015
  • Rules of competition

    How companies can compete with gene therapies that provide a functional cure

    Gene therapy may differ from other therapeutic categories as the first in class to provide a functional cure may get most of the Orphan patients.

    Published on 7/27/2015
  • Figure: Crowding the gene pool

    Rules of competition Crowding the gene pool There are 33 gene therapy products being developed in Orphan indications where there is more than one competitor developing a therapy encoding the same gene. The most …

    Published on 7/27/2015
  • Window to gene therapy

    How AGTC deal helps Biogen grow its new gene therapy unit

    A licensing and manufacturing deal with AGTC will help Biogen grow its new gene therapy research unit.

    Published on 7/20/2015
  • Framing value

    How ASCO's value framework could affect cancer drug uptake, coverage

    ASCO's value framework to help doctors and patients make treatment decisions could also help inform payer decisions about reimbursement.

    Published on 7/20/2015

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