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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent

    $131.00

    A Shanghai testing laboratory has been handed an FDA warning letter for refusing a GMP inspection but told the agency it rightfully did so. Pink Sheet shares the exact working of the FDA letter as well as the highly unusual response from the laboratory.

    September 2, 2019
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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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  • EU Beats Predicted Timelines And Appoints First UK Notified Body Against MDR

    $131.00

    Months ahead of schedule, the EU Medical Devices Regulation has succeeded in designating its first notified body. BSI UK achieved designated status much sooner than anticipated, but does that mean the road ahead for other designations will be as smooth?

    January 22, 2019
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  • Two More EU Notified Bodies But Not On Nando Yet

    $131.00

    Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.

    August 2, 2019
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  • Big Pharma CEOs Get Ready To Testify: Preparing For A No-Win Situation

    $131.00

    Leading pharmaceutical executives called to testify before a Senate Finance Committee hearing on drug prices were likely the first of many to be summoned. It’s a no-win situation, but preparation can help. Find out why changing the subject can be a smart tactic. Discover how some senators may try to lure execs into inadvertently lying–and learn how to avoid it.

    May 13, 2019
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  • Nitrosamine Episode Could Lead To Paradigm Shift In Quality

    $131.00

    The detection of cancer-causing impurities in drugs with well-established safety profiles may call for regulators across the globe to revise their approach for evaluating quality. Pink Sheet looks at whether or not companies seem to know their own products.

    September 2, 2019
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  • Novartis Can’t Halt Janssen’s Promo Comparing Their Psoriasis Drugs

    $131.00

    A US district court judge recently denied a request from Novartis for a temporary restraining order against Janssen. Novartis was railing against Janssen’s promotional claims that Novartis’ IL-17A inhibitor Cosentyx (secukinumab) compares unfavorably to Janssen’s IL-23 inhibitor Tremfya (guselkumab) in safety tests. Find out more here.

    March 5, 2019
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  • CAR-T Label Update Could Address Medicare Coverage Challenges, FDA’s Gottlieb Suggests

    $131.00

    Lifesaving chimeric antigen receptor T-cell (CAR-T) therapies could soon move to outpatient settings, easing the financial burden currently felt by providers, according to US FDA Commissioner Scott Gottlieb, who said a label change to allow for outpatient treatment under Medicare Part B is in the works.

    November 13, 2018
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  • Innovations In Market Access: The Will, But Not The Way?

    $200.00

    An informal round table discussion among more than 20 key market access leaders in biopharma convened by the Boston Consulting Group (BCG) yielded some interesting insights into the innovations that are forcing changes to the way the industry runs.

    March 1, 2019
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  • FDA Ban On Flavoring Ingredients Should Prompt Removal From Fragrances – WVE

    $131.00

    NGO Women’s Voices for the Earth recently called for a ban of five ingredients used in fragrances for personal-care products. These ingredients were recently removed from the safe food additives list by the FDA, despite the FDA’s claims that they pose no risk to public health. Go deeper into this clash between hazard and risk ideologies in this informative article.

    October 18, 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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  • Paying for Pharmaceutical Value: The Problem of a One-Size-Fits-All Definition

    $200.00

    In Vivo takes a look at the hot-button topic of drug value in this thought-provoking article, which examines the role of ICER (Institute for Clinical and Economic Review) and wonders if a more sophisticated method of assigning value in the US market is necessary.

    March 20, 2019
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  • One Cancer Start-Up’s Resolve To Crack The Mystery Of Metastasis

    $131.00

    Rgenix, founded by three brothers who are prominent physician researchers, sees itself at the forefront of cancer treatment. They are finding drugs that shut off metastasis rather than the more common goal of using the immune system to destroy cancer receptors.

    September 24, 2019
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  • Eudamed – A Moving Target But On Track For March 2020 Partial Go-Live

    $131.00

    In a recent update of the European Commission’s Rolling Plan, the Commission noted that while Eudamed, the EU’s databank on medical devices, is due to go live in March of 2020, some essential portions of the database may experience a delay in availability.

    March 1, 2019
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  • Market Intel: Needle-Free Glucose Monitoring, Digital Solutions Are Game-Changers In Growing Diabetes- Monitoring Market

    $200.00

    The continuous glucose monitoring (CGM) segment of the diabetes management market is exploding, while big names in the blood glucose monitoring (BGM) sector are facing increased competition from lower-cost developers and related innovative diabetes-monitoring products. Examine the competitive landscape for CGM and BGM in this informative Medtech Insight article.

    December 6, 2018
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