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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • 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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  • 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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  • Commission Would Back Limited Expansion Of Products Covered By MDR Grace Period

    $200.00

    After much speculation and urges of caution related to whether the European Commission would support a proposal to expand the range of products covered by the Medical Device Regulation’s four-year grace period, the European Commission has now said it will support it.

    August 3, 2019
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  • Commission Looks Set To Expand MDR Extension So Notified Bodies Can Focus On High-Risk Devices

    $200.00

    The European Commission seems like it will widen the grace period for MDD-approved products to comply with the new Medical Device Regulation (MDR), including Class I medical devices that have never before been reviewed by notified bodies. This extension will allow notified bodies to focus on higher-risk products.

    August 2, 2019
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  • Commission Addresses Non-EU/EEA Authorities To Set Record Straight On New EU Regs

    $131.00

    Hoping to head off possible rejection of IVDs and medical devices by other countries for items receiving CE marks under the European Union’s Directives for medical devices, the European Commission has issued a fact sheet for third-countries that explains the issue.

    December 5, 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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  • CMS Actively Looking For New Reimbursement Pathway For Innovative Devices

    $131.00

    The US Centers for Medicare and Medicaid Services (CMS) say they are seeking to improve medical devices reimbursement procedures as the device industry looks for a policy to help breakthrough devices receive temporary and automatic Medicare and Medicaid coverage. Read more here.

    September 28, 2018
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  • CEO-To-Worker Pay Ratios Averaged 150-1 At Six Top Medtech Companies In 2017

    $131.00

    CEOs earned 32- to 215- times that of the median worker at six device companies. Find out which CEO earned $10.8 billion–215 times the median salary–and see how company revenues compare to the CEO/worker pay ratio. The average ratio for the six firms is 150-1: Discover how this compares to other public companies across industries.

    April 9, 2018
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  • Cell And Gene Therapy Logistics Requires Early Planning

    $131.00

    Traditionally, the subject of logistics has not been considered until late in the development process for cell and gene therapy. Industry experts at the October 2018 Cell and Gene Meeting on the Mesa in San Diego suggest that considering logistics early in the planning stages for cell and gene therapy is a critically important move.

    December 7, 2018
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  • Cell And Gene Therapies Test New Waters In Pricing And Reimbursement

    $200.00

    At the annual Alliance for Regenerative Medicine’s Cell and Gene Meeting on the Mesa in San Diego, the struggles of setting pricing and reimbursement for these new, one-time treatments, and the opportunities to influence how these new treatments are paid, were a recurring theme.

    October 5, 2018
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  • CBD Suits Challenge ‘THC-Free’ Claims After Users Fail Drug Tests; Plaintiffs Bar May Just Be Warming Up

    $131.00

    Attorneys are warning CBD product marketers to be on guard for litigation challenging the authenticity of their claims, the safety of their products and other aspects of their businesses – this after users in the US filed suit as a result of testing positive for THC, which they attribute to defendants’ purportedly THC-free cannabidiol products. So far, suits of this nature have been limited in the US, but the few known cases could be the first waves of an impending tsunami to come. Was it false advertising on the part of the defendants, or did they not know their claims of THC-free CBD products to be untrue? In either case, the cost of litigation could be steep.

    August 2, 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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  • Cannabis Industry Taking Legal Action Against EU Regulators Over CBD Novel Food Classification

    $131.00

    In response to the recent controversial European Commission decision to classify products containing cannabidiol (CBD) as “novel foods”, the Cannabis Trades Association UK has begun legal action to challenge the classification. Read more about the controversy and legal proceedings here.

    March 20, 2019
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  • Cancer’s New Patient Demographic; Will Survivorship Change The Face Of Cancer Care?

    $200.00

    As the number of cancer survivors increases, they are reshaping cancer research and clinical practice. Find out how–and discover the impact it will have on the allocation of research dollars. Learn how the looming physician shortage has implications for the emergence and increasing use of complex immunotherapy drugs.

    August 6, 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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