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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Pharma’s New R&D Models: Federating Innovation

    $200.00

    As ROI across R&D investments in big phama declines, companies look for new and innovative ways to access and nurture innovation via partnerships and through the use of new data types.  In the process, the business models, products, and role of big pharma in healthcare is changing.

    June 20, 2018
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  • No More Rebates: HHS Proposed Rule Revises AntiKickback Safe Harbor

    $131.00

    A proposal from the HHS Office of Inspector General to amend the safe harbors-provision in the Anti-Kickback statute could save billions. It would exclude some rebates used by biopharma companies from safe-harbor protection in an effort to reduce prescription costs. Find out how PhRMA and the PBM trade group reacted. Learn how much the proposed change would save. Gain insights into the OIG’s thinking and see what the proposed rule includes.

    January 31, 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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  • Petition Suggests Environmental Laws Compel FDA To Ban Oxybenzone, Octinoxate In Sunscreens

    $131.00

    Citing the negative impact on both coral reefs and human health, the citizen-led Center for Biological Diversity has officially petitioned the US FDA to ban the use of oxybenzone and octinoxate, reportedly present in over 3,500 sunscreens on the market today.

    May 31, 2018
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  • FDA’s Proposed Sunscreen Rule Could Bring SPFs Back Down To Earth, Deter SPF Fraud Suits

    $200.00

    FDA’s proposed SPF rule would cap sunscreen claims at SPF 60+ and establish new broad-spectrum requirements for most sunscreen products, among a host of other changes. Find out how these changes could create a more even playing field among OTC sunscreen marketers and help to deter lawsuits alleging SPF fraud. Gain insights into stakeholder and environmental group perspectives.

    February 19, 2019
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  • ECHA’s Microplastic Ban Proposal Is ‘Brutally Misinformed’ – Cosmetics Europe

    $200.00

    ECHA’s plan to ban the use of intentionally added microplastics in cosmetics is based on “a whole clutch of errors and misunderstandings,” according to Cosmetics Europe’s Director-General John Chave. Find out why the industry is worried about this ban–and why they consider it unfair. Gain insights into which solutions would satisfy the industry, and learn why biodegradable plastics–which represent a potential win-win for industry and environmental advocates–may not be viable.

    February 19, 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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  • Peter Stein Takes Short Path To Director Of US FDA Drug Office

    $131.00

    After only a short stint at the US FDA as Deputy Director of the Office of New Drugs, industry veteran Peter Stein was appointed to his permanent post as Director of the OND in December of 2018, filling a role that sat vacant for nearly two years.

    December 9, 2018
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  • Pfizer’s Reference Point on Trial Innovation : Ask the Patient

    $200.00

    In this interview with Pfizer’s head of clinical innovation, Craig Lipset, learn why clinical trial innovation requires a patient-centered approach and how Pfizer is making this happen. Learn why patient-centricity matters. Explore how the digital revolution is reshaping patient engagement, data collection and the shape of clinical trials.

    May 9, 2018
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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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  • The Blockbusters No One Talks About

    $131.00

    Although their patent protection has expired, big-name blockbusters continue to produce huge revenues for the pharmaceutical companies that produce them. Take a look at how some well-known drugs may no longer be making headlines, but continue to be big earners.

    June 21, 2018
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  • Novartis R&D Chief Tsai On 2019 Goals, Priorities, BD And Digital Advances

    $200.00

    Scrip interviewed Novartis AG’s Head of Global Drug Development at the 2019 J.P. Morgan Healthcare Conference to get his views on how his past experience has prepared him for the job, and where he plans on taking Novartis, especially in regards to business development and digital technology.

    January 16, 2019
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  • Telehealth Reforms Praised At Senate Hearing

    $100.00

    Insurers and a neurologist testifying at a May 16 Senate Finance Committee hearing on the CHRONIC Care Act praised the bill’s telehealth provisions. Committee Chairman Orrin Hatch, R-Utah, says he plans to mark up the bill, which has been under development for two years, this week.

    February 15, 2018
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  • ‘Something’s Going To Happen’: Former FDAer John Bailey On Cosmetics Reform Legislation

    $200.00

    Don’t dismiss cosmetics reform efforts underway in Washington, former FDA official John Bailey warned an Independent Cosmetic Manufacturers and Distributors workshop. At the same gathering, Linda Katz, director of FDA’s Office of Cosmetics and Colors, hinted broadly at what’s ahead. Find out what she had to say and gain insights into what’s expected to be the first major regulatory/legislative overhaul in decades

    May 21, 2018
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  • Data, AI And Machine Learning Are Propelling Clinical Trials Data Analysis To New Heights

    $200.00

    At the recent Medidata NEXT London meeting, Medidata Solutions, Inc., explained their new Clinical Cloud solution, part of the new crop of clinical trials and data analysis tools that only a few years ago, seemed like a distant dream. Read how Clinical Cloud and other clinical trials tools are taking data analysis to new heights in this informative article.

    May 16, 2018
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