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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

    $200.00

    Sanofi plans to continue distributing Zantac OTC heartburn remedy in the US while conducting its own tests to determine whether levels of N-nitrosodimethylamine (NDMA) in the active ingredient are above safe levels, Novartis AG, which licenses OTC Zantac, has said it stopped distribution worldwide.

    August 2, 2019
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  • Amarin CEO: Consumers Have Heard About Omega-3 Heart Benefits ‘Too Long’

    $200.00

    Amarin’s John Thero says the firm expects a jump in sales for Vascepa from potential label expansion allowing a larger patient groups with lower triglycerides than current label indications. At the same time, he notes competitors fail to show broader cardiovascular risk reduction.

    August 2, 2019
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  • Sanofi Offloads Two German OTC Brands, New CEO Prepares To Make Mark

    $200.00

    Sanofi signaled earlier this year it would continue to rationalize its Consumer Healthcare portfolio and focus on several priority brands and categories. Now they have divested two brands in Germany and Austria. HBW covers the details including plans of the firm’s CEO.

    August 2, 2019
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  • Ranitidine Recalls Begin In Europe As Regulators Take Action

    $200.00

    Over the counter products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs. HBW covers how investigations are underway worldwide while regulators across Europe are divided between “take immediate action” and “wait and see”.

    August 3, 2019
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  • Novartis Swaps Two AveXis Executives For One Following Zolgensma Data Manipulation

    $200.00

    AveXis co-founder and CSO Brian Kaspar and his brother are no longer with Novartis, the Swiss manufacturer who acquired AveXis and its Zolgensma drug in 2018. After disclosing data manipulation to the FDA earlier this year about Zolgensma filings, Novartis announced two employees would exit the company.

    August 14, 2019
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  • Novartis Battens Down Hatches Over Falsified Zolgensma Data

    $131.00

    The FDA is investigating data manipulation issues associated with Novartis’s filing for their type 1 spinal muscular atrophy drug, Zolgensma. This Scrip story looks at the claims, background on the issue, and the Swiss manufacturer’s recent response.

    August 7, 2019
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  • Novartis’s Zolgensma Loses EU Accelerated Assessment

    $200.00

    Novartis’s Zolgensma losing EU accelerated assessment serves as a warning to other companies. This Scrip story covers a half dozen other examples of companies and drugs who are now forced to slow their development pace—opening room for competitive threats.

    July 26, 2019
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  • Top 10 Drugs: Biologic Blockbusters And The Biosimilar Threat

    $131.00

    Pharma companies faced a “patent cliff” a decade ago with generic competition threatening to slash sales of certain blockbusters. The new threat is biosimilars. Scrip shows how some mature cancer and autoimmune biologics are still the major drivers of revenues, and how biosimilars are gaining on them.

    August 9, 2019
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  • Top 10 Drugs: Weighing Pharma’s Golden Eggs

    $131.00

    A relatively small number of costly drugs account for a sizable portion of pharma industry revenues. This informative and easily scannable Scrip infographic shows which drugs are the golden eggs, which companies are behind them, and how the landscape has changed in the past decade.

    August 6, 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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  • Orphan Drug Pricing And Reimbursement: Challenges To Patient Access

    $131.00

    While the drug industry and patient advocacy groups have worried about price controls or reimbursement restrictions for drugs that treat orphan diseases, a review of formulary data shows that patient access to high-priced drugs has not been severely hampered despite some payer pushback.

    August 2, 2019
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