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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • 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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  • 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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  • ‘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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  • 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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  • How To Pay For The New Wave Of Gene Therapies

    $131.00

    Pink Sheet spoke with Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, who says, “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 3, 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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  • 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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  • ESMO Preview: Five Key Oncology Battlegrounds To Watch

    $200.00

    With Europe’s biggest cancer congress ESMO attracting large and small companies to present the latest data readouts across a broad range of tumor types, Scrip looked at the key players and the five key battlegrounds at stake.

    August 3, 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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  • 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
    Find out more

  • Testing Ranitidine with Too Much Heat Could Generate NDMA, FDA Say

    $131.00

    The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratory’s use of the incorrect test for the drug treatment. HBW covers the recommended testing method.

    September 2, 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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  • Serious Skin Reactions Reported with Ibuprofen Use in Europe

    $131.00

    The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee advises ibuprofen manufacturers to add warnings on patient information leaflets concerning acute generalized exanthematous pustulosis associated with use of the drug. HBW provides details about the skin reaction being noted and the informational changes required.

    September 2, 2019
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  • A Hangover Is A Disease, German Court Rules

    $131.00

    Alcohol-related hangovers are genuine illnesses according to a recent ruling by a high-level German court. HBW looks at the case against a German wellness manufacturer for health claims made for its “anti-hangover” supplements and how deeming hangover’s a disease affects the outcome of the case.

    September 2, 2019
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