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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Accenture Prescribes A New Data Management Future For Medtechs

    $200.00

    In Vivo examines efforts by Accenture Life Sciences to survey medtech CEOs on their digital preparedness as leaders look to build new revenue streams from innovative business models by effectively managing data. Discover what trends they uncovered in this illuminating article from In Vivo.

    November 21, 2018
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  • Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

    $130.00

    On September 28, 2018, the US FDA issued new draft guidelines for adaptive clinical trial designs, as well as additional guidance updates. Tap into these important updates, which replace draft guidance issued by the agency in 2010.

    September 30, 2018
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  • AHPA Backs NDI Filing For Kratom, Experts Question FDA Enforcement

    $200.00

    AHPA called on FDA to regulate kratom as an NDI to avoid a patchwork of state regulations. Kratom, used to manage opioid withdrawal, garnered unwelcome scrutiny after being linked to a salmonella outbreak. Will the FDA treat it like any other dietary ingredient? Find out what may lie ahead for this herbal extract.

    April 30, 2018
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  • Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm

    $131.00

    Speaking with Scrip recently, Amarin CEO, John Thero talked about the upcoming US advisory committee meeting for Vascepa and commercial expansion plans and deflected questions about a big pharma buyout. What he did say was that, “We’re planning for success.

    September 2, 2019
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  • Amarin CEO: Consumers Have Heard About Omega-3 Heart Benefits ‘Too Long’

    $200.00

    Amarin’s John Thero says the firm expects a jump in sales for Vascepa from potential label expansion allowing a larger patient groups with lower triglycerides than current label indications. At the same time, he notes competitors fail to show broader cardiovascular risk reduction.

    August 2, 2019
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  • An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain

    $200.00

    The US FDA intends to make changes to its 501(k) process, and is currently considering a proposal to impose an age limitation on predicate devices as a means of encouraging the use of more modern predicates. Opponents of the plan argue that such a step would do little to achieve the FDAs goals in this area.

    April 18, 2019
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  • Analysts Weigh Up Benefits Of Big Bayer Restructuring

    $131.00

    The recent shakeup at Bayer AG took some observers by surprise, but was heralded by most as a much-needed measure to maintain the German giant’s viability. Find out how this restructuring will play out, and what top analysts make of the move to streamline the organization.

    November 30, 2018
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  • Annuity Payment Model For Cures May Get Test Drive In Massachusetts

    $131.00

    Commercial payers in Massachusetts and AveXis may soon pilot an annuity payment model for Zolgensma. This would spread out insurance payments for the high-cost treatment over years to reduce the burden on payers. The pilot will likely involve a performance component. Learn who the players are and what they stand to gain–and what they risk. Find out how the annuity model would work in practice.

    February 19, 2019
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  • Anti-Aging Cosmetics Or Unlawfully Marketed Drugs? Two Federal Court Cases To Watch

    $131.00

    Skin-firming and anti-wrinkle claims on products marketed as cosmetics are being tested in California federal course. The results will have considerable implications on the health, beauty and wellness industry. HBW looks at similarities and differences of the two cases.

    September 2, 2019
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  • As Humira Biosimilars Arrive, Battle Lines Shift From Education To Sustainability

    $200.00

    As a European wave of Humira biosimilars challenges the best-selling drug in the world, the question of how biosimilars will affect the market, from payers, to practitioners, to patients, comes to the forefront. Examine how biosimilars are poised to change the landscape as focus shifts from whether to adopt their use to how to actually use them effectively.

    October 15, 2018
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  • ASCO 2018: Optimism As Industry Resets And Looks To What Is Next

    $200.00

    The tone of the 2018 ASCO annual meeting was one of regrouping, resolve, and refinement that may have left investors apathetic, but signaled a commitment to getting it right going forward to those in pharma. Examine the key takeaways from ASCO 2018.

    June 4, 2018
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  • Bayer’s Consumer Chief Initiates Turnaround Plan In Bid To Return Troubled Business To Growth

    $200.00

    Bayer AG is seeking to turn around its troubled Consumer Health division through implementing key portfolio changes and embracing growth-focused innovation, according to Heiko Schipper, President of Consumer Health.  Find out what’s in store for Bayer AG’s Consumer Health group, straight from its top leadership.

    December 17, 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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  • Behind The Scenes Of Digital Health: Medtech Players And Partners

    $100.00

    The digitalization of health care has been much talked about over the last decade or so. But activity among the medical device manufacturers and service providers has only just recently accelerated as they start overcoming barriers and resistance to this new way of delivering health care.

    February 5, 2018
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  • Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971

    $200.00

    Find out how the International Organization for Standarization (ISO) has changed its benefit-risk language in the wake of shifting attitudes towards flawed devices which nonetheless do deliver health benefits. Medtech Insight spoke with Jos Van Vroonhoven, who convened the joint working group that revised the standard, for an inside look at what has changed.

    January 10, 2019
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