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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Novartis’ New Oncology CEO Liz Barrett Charts A Course, But It Will Require Jump-Starting New Brands

    $200.00

    Novartis Oncology CEO and newcomer to the company, Liz Bennett, sat down with Scrip ad talked about her plans for an organization currently in transition, and her strategy for moving new blockbusters forward. Access her insights into the future of Novartis Oncology in this illuminating interview.

    June 6, 2018
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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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  • 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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  • 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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  • Lilly Prices Olumiant For JAK Battle, But Misses Approval For Higher Dose

    $200.00

    How do you compete with rheumatoid arthritis giants Humira and Xeljanz? Eli Lily & Co. is betting that pricing their janus kinase (JAK) inhibitor, Olumiant at 50% and 60% less, respectively, may just do the trick. Find out more about Lily’s gambit, even as Olumiant failed to gain FDA approval for a 4mg dose.

    June 2, 2018
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  • Sunshine rules in the EU: Implications of a piecemeal approach

    $200.00

    The EU’s piecemeal approach to transparency makes compliance harder, but this expert advice can smooth the path forward. Learn about implications of these”sunshine”rules in the EU and U.S., how they differ,and what the EU can learn from the U.S.

    June 1, 2018
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  • FDA investigator insights: Device makers forget about the humans who use their products

    $200.00

    Device makers often fail to consider what happens once their product is in a patient’s hands, says a seasoned U.S. FDA investigator. She identifies seven common human-factor–usability–problems. Learn what they are so you can enhance compliance and patient safety.

    May 31, 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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  • Infographic – 2018 Pharma Pipeline Snapshot

    $131.00

    How does the 2018 pipeline compare to 2017’s? In Vivo’s 2018 pipeline infographic examines pipelines by therapeutic area, company and phase. Find out which therapeutic areas are growing, which are shrinking, and which pharma companies have the most robust portfolios.

    May 28, 2018
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  • UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

    $200.00

    Leading UK and EU notified body BSI expects the UK to remain a full member of the EU regulatory regime post-Brexit, but it has a contingency plan. Learn what this contingency plan means for device manufacturers. Gain insights into the implications of a non-negotiated Brexit, and find out if the other notified bodies have contingency plans.

    May 25, 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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  • Immuno-Oncology: What To Watch At ASCO 2018

    $200.00

    Immunotherapy dominated the American Society of Clinical Oncology 2018 annual meeting. PD-1/L1 inhibitors were among those taking center stage–find out which ones hold the most promise for NSCLC. Gain insights into why Jounce’s ICOS antibody JTX-2011 proved to be such a disappointment–and why this affects Celgene investors.

    May 17, 2018
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  • Data, AI And Machine Learning Are Propelling Clinical Trials Data Analysis To New Heights

    $200.00

    At the recent Medidata NEXT London meeting, Medidata Solutions, Inc., explained their new Clinical Cloud solution, part of the new crop of clinical trials and data analysis tools that only a few years ago, seemed like a distant dream. Read how Clinical Cloud and other clinical trials tools are taking data analysis to new heights in this informative article.

    May 16, 2018
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  • Data, AI And Machine Learning Are Propelling Clinical Trials Data Analysis To New Heights

    $200.00

    Big data, AI and machine learning are no longer mere buzzwords; they have transformed clinical trial data analysis. Learn how technological advances can address both the high-touch challenges posed by patient engagement and the high-tech challenge of turning unstructured data into actionable information for clinical trials

    May 16, 2018
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