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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Contamination In Common OTC Antacid Adds To FDA’s API Impurity Concerns

    $131.00

    The US Food and Drug Administration is considering how to respond after a contaminant was found in drugs containing, ranitidine, the active ingredient in Sanofi’s Zantac OTC heartburn remedy and multiple generic equivalents. HBW also looks at similar investigations in Europe

    August 2, 2019
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  • Regulatory headaches: Brexit’s not the only thing you need to worry about

    $131.00

    A no-deal Brexit would dramatically affect regulatory alignment and trade, but it’s far from the only regulatory concern in the medtech industry. Learn about the various challenges, including GDPR and the uncertainty around the new Medical Device and IVD Regulations.

    June 5, 2018
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  • Novartis Pharma CEO Sees Zolgensma Supplanting Spinraza

    $131.00

    Will Novartis’ Zolgensma or Biogen’s Spinraza be the standard of care for spinal muscular atrophy? Novartis shared its perspective with Scrip. Find out what Biogen had to say about the competition during an earnings call–and read how Novartis’ Paul Hudson responded. Learn how Novartis plans to handle payments for the expensive therapy. Is it considering outcomes-based payments? Gain insights into the clinical benefits of both medications and learn what’s next.

    February 1, 2019
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  • Gilead Lures Roche Pharma CEO O’Day As CEO; Genentech’s CEO Will Replace Him

    $131.00

    A leadership shakeup at Roche Pharmaceuticals resembles a game of musical chairs, as Roche’s CEO steps down to join Gilead as chairman and CEO, while the lead at Roche-owned Genentech moves over to fill the top position at Roche.

    December 10, 2018
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  • Six Questions For McKinsey Executives On Pharma’s Digital Experience

    $200.00

    Scrip sat down with the heads of McKinsey & Company for an informative Q&A about pharma’s efforts to expand and update in the areas of advanced analytics and digitization. Tap into their insights about where the industry is now, and where it may soon be heading.

    March 8, 2019
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  • Paying For Gene Therapy: Will Pharma Be First In Line?

    $200.00

    In considering pricing models for the increasingly important area of gene therapy, what are the options facing biopharma? This article from In Vivo explores the question of how to pay for gene therapy in a way that’s sustainable to developers of these potentially curative therapies, while ensuring patient access.

    June 12, 2018
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  • ‘Something’s Going To Happen’: Former FDAer John Bailey On Cosmetics Reform Legislation

    $200.00

    Don’t dismiss cosmetics reform efforts underway in Washington, former FDA official John Bailey warned an Independent Cosmetic Manufacturers and Distributors workshop. At the same gathering, Linda Katz, director of FDA’s Office of Cosmetics and Colors, hinted broadly at what’s ahead. Find out what she had to say and gain insights into what’s expected to be the first major regulatory/legislative overhaul in decades

    May 21, 2018
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  • Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

    $131.00

    A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be deemed BLAs in six months as the FDA is addressing the transition of authorized generic insulins to regulation under the PHS act.

    September 2, 2019
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  • Strategy At Novartis: Culture Change As The ‘How’ Behind The ‘What’

    $200.00

    Go behind the scenes at Novartis via an In Vivo interview with the company’s Global Head of Strategy, Stephen Moran. Moran discusses the secret behind effective strategy planning, as Novartis navigates a new era of culture change, enhanced risk management, and functional integration.

    November 19, 2018
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  • Colgate/Tom’s Of Maine Pays Back Unilever For ‘Naturally Dry’ Loss

    $131.00

    It’s payback time for Unilever, as the maker of Schmidt’s deodorants must re-label its products, removing reference to certain wetness-absorption claims. In 2016, Unilever was responsible for making close competitor Colgate’s Tom’s of Maine remove similar claims to their deodorant products at a self-regulatory forum.

    June 7, 2018
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  • Data in Healthcare: Underpinning the Shift to Value

    $2,995.00

    Data plays a key role in healthcare systems’ shifts towards value-focused outcomes. Such data includes outcomes and cost data, adherence data, and increasingly, patient-reported data, behavioral and social media data.

    November 23, 2016
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  • US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

    $131.00

    The US FDA plans to “harmonize domestic and international requirements, and modernize the regulation” through a new rule that will blend its Quality System Regulation (QSR) with ISO 13485. Will FDA will swap out the QSR with ISO 13485? Probably not. Find out what it will likely do instead–and when it will do it.

    May 9, 2018
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  • Engaging Patients and Navigating Laws: What To Consider When Developing Health Apps

    $100.00

    Victoria Hordern and Amy Merrick discuss initiatives in the EU to help app developers navigate the unclear rules on mobile health and explain why engaging patients during product development is key.

    February 5, 2018
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  • IXICO Targets Go-To Status In Neuro Data Analytics Space

    $131.00

    IXICO is a neuroscience data specialist that wants to partner with large and small pharmas to help them develop better-targeted clinical trials using imaging and digital biomarkers data. In Vivo looks at the CEO’s activity planning review and subsequent leadership restructuring.

    August 2, 2019
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  • AbbVie Hit Harder By EU Humira Biosimilars Than Projected

    $131.00

    AbbieVie’s Q3 earnings call was a chance for analysts and investors to ask tough questions about the worse-than-projected impact of the first adalimumab (Humira) biosimilars to hit the European markets. Executives remained optimistic for the future of the blockbuster drug and the financial well-being of the company.

    November 2, 2018
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This is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.
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