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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • How To Pay For The New Wave Of Gene Therapies

    $200.00

    Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, recently told Scrip, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”

    August 2, 2019
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  • Farxiga Data Change Heart Failure Treatment Outlook

    $200.00

    AstraZeneca’s Farxiga (dapagliflozin) appears set to become new standard or care in the treatment of hear failure based on results of the DAPA-HF Phase III trial present at the European Society of Cardiology Congress on 1 September. Scrip looks at Farxiga and its nearest competitors.

    August 2, 2019
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  • Novo Nordisk’s Oral Rybelsus Priced On Par With Injectable GLP-1s, But Big Discounts May Be Needed

    $200.00

    While a 30-day supply of the first oral GLP-1 agonist will cost $772.43, similar to the injectable version, this is still steeper than oral diabetes medicines and Scrip looks at how deep discounts may be needed to secure market access.

    August 2, 2019
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  • Roche: We’ve Abandoned Budgets And It’s Liberated Employees

    $200.00

    Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? Scrip talks to one CEO who knows.

    August 2, 2019
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  • US FDA Looks To Standardize Premarketing Safety Assessments

    $131.00

    A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.

    August 2, 2019
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  • ‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications

    $200.00

    The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program. Pink Sheet covers how the FDA will focus on applicants that are expected to have a major impact on the standard of care.

    August 2, 2019
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  • Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

    $200.00

    At a meeting of mitochondrial disease drug development, officials of US Food and Drug Administration said that just because a measure is relevant to the patient community does not mean it can capture meaningful change in a clinical trial. Pink Sheet looks at the implications to sponsors.

    August 2, 2019
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  • US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

    $200.00

    After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.

    August 2, 2019
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  • EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

    $131.00

    Consultant Sarah Sorrell offers insights on the EU’s new medtech regulations that have introduced much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. Medtech interviewed her about what the requirements entail and problems with understanding them.

    August 2, 2019
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  • FDA’s Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

    $200.00

    A new Technical Information Report from the Association for the Advancement of Medical Instrumentation aims to help befuddled US device makers that operate under the FDA’s QSR ensure they are compliant with standard from the ISO.

    August 2, 2019
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  • Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?

    $200.00

    Two medical device manufacturers have been granted the first certificates under the EU’s new regulations that are coming into force next year. Medtech looks at whether this is a sign that the whole sector is going to be able to meet regulations.

    August 2, 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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  • EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

    $200.00

    The post-market clinical follow-up requirements for device and diagnostics companies based on the new medtech regulations are complex. They contain vague terms that need clarification for companies to understand how to comply. Expert and consultant Sarah Sorrel provides her interpretation in this interview with Medtech Insight. 

    August 2, 2019
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  • European Commission Highlights Medtech Notified Bodies Giving It Cause For Concern

    $131.00

    With higher standards and new, demanding regulations for EU notified bodies, six notified bodies have been called into question by the European Commission. All are listed with warnings on the Commission’s Nando database. Some of those six offer testing in other medtech directives, and in those other directives, they remain competent.

    August 2, 2019
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