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  • 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
  • Box: Trulicity adapts

    Haste, not waste Trulicity adapts In developing its regulatory package for Trulicity dulaglutide, Eli Lilly and Co. used computer simulations to determine the range of doses to be studied in its dose-finding trial…

    Published on 9/5/2016
  • Box: Woodcock's wish list

    Haste, not waste Woodcock's wish list CDER Director Janet Woodcock's prescription for better, faster drug development includes to-dos for industry, FDA and academic researchers that range from common-sense best …

    Published on 9/5/2016
  • Figure: Reasons for failure

    Haste, not waste Reasons for failure According to an FDA analysis of applications for NMEs submitted between 2000 and 2012, the most common reason for denying approval was a failure to select an appropriate dose. …

    Published on 9/5/2016
  • Figure: Seamless and speedy

    Haste, not waste Seamless and speedy Pfizer Inc. (NYSE:PFE) and Merck & Co. Inc. (NYSE:MRK) used seamless Phase I protocols to gain rapid approval of targeted cancer agents. Pfizer's Xalkori crizotinib received …

    Published on 9/5/2016
  • Figure: Selecting for success

    Haste, not waste Selecting for success According to a BIO report on clinical success rates during 2006-15, 69% of all programs did not make it out of Phase II, and 42% failed to move from Phase III to filing. The …

    Published on 9/5/2016
  • Table: Basket case studies

    Haste, not waste Basket case studies At least six Phase II basket trials are studying one or more targeted agents across a range of cancers or cancer subtypes defined by a molecular signature, not by tissue of …

    Published on 9/5/2016

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