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  • How much is enough?

    Digging in to FDA's scientific dispute about DMD drug Exondys 51

    FDA's Woodcock and Unger disagreed on one fundamental question about Exondys 51: how much dystrophin expression predicts clinical benefit in DMD?

    Published on 9/26/2016
  • Digging into dosing

    How Sarepta, FDA can determine dose for Exondys 51's confirmatory trial

    Sarepta's scanty clinical program gives small clues to choosing a dose of Exondys 51 that will produce enough dystrophin.

    Published on 9/26/2016
  • Box: Bungled

    Not so fast Bungled Despite a difference of opinion whether to grant accelerated approval to Exondys 51 eteplirsen from Sarepta Therapeutics Inc., senior FDA officials and review staff agree the biotech badly …

    Published on 9/26/2016
  • Box: Defending Woodcock

    Not so fast Defending Woodcock FDA Commissioner Robert Califf used a memo about disputes over the accelerated approval of Sarepta Therapeutics Inc.'s Exondys 51 eteplirsen to air and refute criticisms that have …

    Published on 9/26/2016
  • Not so fast

    Why approval of Exondys 51 might be a setback for patient-focused regulation

    Approval of Exondys 51 was both a resounding victory for DMD advocates, and a likely setback for patient-focused regulation.

    Published on 9/26/2016
  • Wrong again

    Why Sarepta's $300K price for DMD drug invalidates reasons for accelerated approval

    If the $300,000 price tag Sarepta put on Exondys limits the drug's use to a fraction of DMD patients, there was no point to accelerated approval.

    Published on 9/26/2016
  • Box: Considering CGRP

    Getting ahead of headache Considering CGRP Migraine is associated with elevated levels of calcitonin gene-related peptide (CGRP), a multifunctional neuropeptide that plays multiple roles in the central and …

    Published on 9/19/2016
  • Box: Oral persistence

    Getting ahead of headache Oral persistence Several companies are developing small molecule antagonists of calcitonin gene-related peptide for migraine treatment and prevention. Peter Goadsby, a King's College …

    Published on 9/19/2016
  • Table: Chronic migraine comps

    Getting ahead of headache Chronic migraine comps In chronic migraine prevention, differences in study designs used by developers of mAbs against calcitonin gene-related peptide (CGRP) or its receptor make it …

    Published on 9/19/2016
  • Table: Episodic migraine comps

    Getting ahead of headache Episodic migraine comps Data from 12-week Phase II trials to prevent episodic migraine do not show any obvious differentiation among four mAbs targeting calcitonin gene-related peptide (…

    Published on 9/19/2016
  • Getting ahead of headache

    How anti-CGRP mAbs may fare in the migraine prevention space

    Anti-CGRP mAbs are safe and effective enough to expand the migraine prevention market, but getting there will take time.

    Published on 9/19/2016
  • Executive power

    Executive agencies, not Congress, will be pharma's greatest threats in Washington

    Congressional investigations are getting attention now, but drug pricing action in the next administration will likely come from the executive branch.

    Published on 9/12/2016
  • Box: Who's on the bench

    Executive power Who's on the bench Three veterans of the Obama White House who helped craft and implement the Affordable Care Act (ACA) are advisers to Hillary Clinton and are candidates for influential jobs if …

    Published on 9/12/2016
  • Table: Biopharma friends

    Executive power Biopharma friends Some of the pharma industry's top supporters in Congress are in close races this year. In the Senate, allies under threat include Richard Burr (R-N.C.), Rob Portman (R-Ohio), and …

    Published on 9/12/2016
  • Table: Powering price constraints

    Executive power Powering price constraints The next administration will have many options to use executive authority to tackle drug spending. The table shows selected proposals from Hillary Clinton, the Medicare …

    Published on 9/12/2016
  • Progressive ideas

    Think tank with Clinton ties proposes comparative effectiveness requirements

    The Center for American Progress wants to align drug prices with value. Hillary Clinton agrees.

    Published on 9/12/2016
  • Haste, not waste

    24th BioCentury Back to School Issue: Revolutionize clinical development

    As costs increase and price pressures mount, the 24th Back to School essay says drug developers must revolutionize the 'D' in R&D.

    Published on 9/5/2016
  • Box: Adapting in AD

    Haste, not waste Adapting in AD The European Prevention of Alzheimer's Disease Consortium plans to launch an adaptive Phase II platform trial in AD next year that will not only identify candidates with a Bayesian …

    Published on 9/5/2016
  • Box: Framing the evidence

    Haste, not waste Framing the evidence This year, the Foundation for the National Institutes of Health is expected to publish a framework that will outline the basic evidence required for biomarker qualification …

    Published on 9/5/2016
  • Box: Making up for lost time

    Haste, not waste Making up for lost time AM-Pharma B.V. expects an adaptive Phase II study of its recombinant alkaline phosphatase will shave a year off the development timeline for the use of recAP in acute …

    Published on 9/5/2016
  • Box: Mod(ern) medicine

    Haste, not waste Mod(ern) medicine Novartis AG developed multiple comparison procedure modeling (MCP-Mod) to help ensure that the dose selected for Phase III is optimal from both a safety and an efficacy …

    Published on 9/5/2016
  • Box: Model citizens

    Haste, not waste Model citizens Pfizer Inc. adopted model-informed drug development as a companywide approach in 2005 with the aim of reducing the rate of late-stage study failures. According to a paper published…

    Published on 9/5/2016
  • Box: Naturally shorter

    Haste, not waste Naturally shorter Ionis Pharmaceuticals Inc. used data from a natural history study to identify an endpoint in spinal muscular atrophy that allowed its ongoing pivotal study to read out at least …

    Published on 9/5/2016
  • Box: Premarket pragmatism

    Haste, not waste Premarket pragmatism GlaxoSmithKline plc did a lot of upfront work to get its premarket pragmatic Salford Lung Study off the ground and is now exploring other diseases where it could gather real-…

    Published on 9/5/2016
  • Box: Regulatory oscillations

    Haste, not waste Regulatory oscillations Regulators in Japan and China may not be asking for more novel trials and modeling approaches to the extent FDA and EMA are, but that does not mean they aren't game. In …

    Published on 9/5/2016

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