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You are here: Home > Opinion & analysis

Opinion & analysis


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  • J&J Scores Early In ‘Hypoallergenic’ Case; Plaintiff’s Definition ‘Implausible,’ Court Says

    $200.00

    What’s the meaning of “hypoallergenic”? Judges in the federal court Northern District have disagreed, with a judge recently siding with Johnson & Johnson’s definition of the term as part of an ongoing lawsuit.  Find out more about the suit and its implications for your business in this article from Rose Sheet.

    June 27, 2018
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  • Petition Suggests Environmental Laws Compel FDA To Ban Oxybenzone, Octinoxate In Sunscreens

    $131.00

    Citing the negative impact on both coral reefs and human health, the citizen-led Center for Biological Diversity has officially petitioned the US FDA to ban the use of oxybenzone and octinoxate, reportedly present in over 3,500 sunscreens on the market today.

    May 31, 2018
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  • Cosmetic Preservatives Crisis Creeping Into CIR Program

    $131.00

    The assessment of cosmetic preservative safety continues to be complex and fraught with controversy, as some in the industry look to the Cosmetic Ingredient Review (CIR) program to set the record straight about the use of certain cosmetic preservative ingredients.

    June 10, 2018
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  • It’s Complicated: FDA Prohibits CBD In Supplements, Enforcement Priority On Disease Claims

    $200.00

    The FDA recently approved its first-ever approval of a drug that contains a marijuana derivative, but the agency says that it will only focus its enforcement policy of similar dietary ingredients on products marketed with drug or disease claims. Find out more about this complex issue here.

    June 25, 2018
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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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  • Bayer’s US Playbook: The Smart Way To Top-Line Growth

    $200.00

    Tap into Bayer AG’s plans to establish itself as a global innovator, particularly with their oncology, cardiovascular, and women’s health franchises. In this exclusive interview, In Vivo talks strategy with Dr. Carsten Brunn, Bayer’s Head of Pharmaceuticals, Americas Region.

    June 18, 2018
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  • Pharma’s New R&D Models: Federating Innovation

    $200.00

    As ROI across R&D investments in big phama declines, companies look for new and innovative ways to access and nurture innovation via partnerships and through the use of new data types.  In the process, the business models, products, and role of big pharma in healthcare is changing.

    June 20, 2018
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  • State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

    $200.00

    Biopharma industry veteran Tadataka “Tachi” Yamada sits down with In Vivo for an exclusive interview that draws on his years of experience in many roles across the R&D ecosystem to explore the state of today’s biopharma R&D enterprise.

    April 9, 2018
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  • GE Healthcare’s New Value Proposition: The Strategic Language Of Software

    $200.00

    Access this exclusive In Vivo interview with Tom McGuinness, President and CEO, Imaging at GE Healthcare. He reveals GE’s secret to success in speed-to-market product launches, and explains how GE is using data analytics and software innovations to reach patients, faster.

    February 21, 2018
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  • Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions

    $200.00

    Changes are coming to the structure of the FDA’s Center for Drug Evaluation and Research division the Office of New Drugs. This long-planned reorganization is still in the nascent stages, but expected to bring a more modern approach that, along with IT improvements and other streamlined processes, will make drug reviews more efficient.

    June 4, 2018
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  • Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

    $200.00

    During the opening session of the American Society of Clinical Oncology’s annual meeting, FDA Commissioner Scott Gottlieb announced the agency’s commitment to moving drugs through faster to market, and unveiled two pilot programs the FDA is initiating with the goal of speeding up the drug review process.

    June 3, 2018
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  • Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

    $131.00

    Roche is leading the charge in the emerging field of using real-world evidence (RWE) with its recent acquisition of Flatiron Health, Inc. and Flatiron’s electronic health records database. Take a closer look at the use of RWE in actual practice in this illuminating article from Pink Sheet.

    June 14, 2018
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  • Drug Firms Fear PBM ‘Discrimination’ Over List Price Reductions, Azar Tells Hearing

    $131.00

    Despite remarks from the US President to the contrary, US pharmaceutical companies have not yet voluntarily lowered their prices. Health and Human Services Secretary Alex Azar discusses the reasons why, and delves into the use of regulations as a means of prohibiting rebates in this illuminating article from Pink Sheet.

    January 3, 2019
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  • EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

    $131.00

    Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.

    June 8, 2018
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  • New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead

    $200.00

    The new EU Medical Device Regulation (MDR) includes an option to market CE-marked devices for an extra four years. That extension may sound tempting, but experts advise against it. Learn about their concerns and gain insights into howto prepare for compliance under MDR.

    June 13, 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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