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You are here: Home > Opinion & analysis

Opinion & analysis


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  • ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

    $131.00

    The most recent version of International Standardization Organization’s ISO 13485 hasn’t even gone into effect yet and already the Technical Management Board is looking for a rewrite, calling for the standard to be rewritten in a “high-level” format. Find out more here.

    November 2, 2018
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  • Focus More On Patients, Less On Hospitals, Experts Tell Device Companies

    $131.00

    Several medtech industry experts sat down with Medtech Insight to share their views on how the medical devices industry can remain competitive in a shifting healthcare climate by moving its focus to serving patients, rather than catering to doctors and hospitals.

    November 1, 2018
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  • BSI Is Designated In Netherlands, Giving Clients Go-Ahead To Start Transfer Of Certificates

    $131.00

    With the details of Brexit as yet unresolved, UK standards and certification body BSI has successfully achieved a notified body designation in the Netherlands, securing a more stable future by allowing certificate holders to migrate UK conformity assessment certificates from the UK to the Netherlands if they wish.

    November 13, 2018
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  • The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While ‘Wrath’- Behrendt Fumes

    $131.00

    In the wake of scathing investigative reports from over 250 journalists from the International Consortium of Investigative Journalists (ICIJ) regarding the safety and oversight of implanted medical devices, this article examines the situation from a uniquely EU perspective.

    November 26, 2018
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  • Device Sector Braces For Investigative Stories Critical Of Industry

    $131.00

    Rumblings of a series of reports and broadcasts from the International Consortium of Investigative Journalists (ICIJ) have gotten louder in the past few months, as the industry braces itself for the release of these sprawling investigations, believed to be highly critical of the medical devices industry.

    November 21, 2018
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  • Luxturna Approved In EU: Novartis Outlines Lessons For Gene Therapy Strategies

    $131.00

    Novartis/Spark Therapeutics readies the launch of its first-ever gene therapy, thanks to approval from the European Commission. Luxturna marks the start of a new strategy for the Swiss drug giant, as Novartis AG’s Global Head of Product and Portfolio Strategy told Scrip in an exclusive interview.

    November 23, 2018
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  • R&D Heads At GSK & AZ Say Key To Success Lies In Smart Risk Taking

    $131.00

    What’s the secret to successfully transforming research and development innovation into drug launches? Taking risks, but doing so in a focused, smarter way, say the heads of Britain’s two largest pharma companies. Read more about the secrets to their success here.

    November 15, 2018
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  • Neuroscience Is The Next Oncology: Why Biogen Is Doubling Down

    $131.00

    Other big names may be withdrawing from neuroscience R&D, but Biogen has seen opportunity in the area, choosing to go in big, filling the space left by the recent GlaxoSmithKline PLC, Pfizer Inc., AstraZeneca PLC, Novartis AG, and Sanofi neuroscience exodus.

    November 23, 2018
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  • New Year Present For Takeda As Shire Close Nears?

    $131.00

    The wheels are turning for Takeda’s huge acquisition of Shire, assuming the European Commission’s approval on antitrust concerns, and the approval of the respective companies’ stakeholders. The $62.4b deal is the biggest overseas M&A deal in Japanese history, and brings with it speculation of future divestments by Takeda.

    November 12, 2018
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  • AbbVie Hit Harder By EU Humira Biosimilars Than Projected

    $131.00

    AbbieVie’s Q3 earnings call was a chance for analysts and investors to ask tough questions about the worse-than-projected impact of the first adalimumab (Humira) biosimilars to hit the European markets. Executives remained optimistic for the future of the blockbuster drug and the financial well-being of the company.

    November 2, 2018
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  • You Work In The Pharmaceutical Industry; Here’s Why You Should Care About The Novartis Payments

    $200.00

    Novartis AG’s involvement–however tangential–in the Donald Trump/Michael Cohen/Stormy Daniels scandal is just the latest incident to tarnish the pharmaceutical industry’s public image. Explore how negative public perception could accelerate the move to price controls–and why it’s an industry-wide problem.

    May 9, 2018
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  • Takeda/Shire Merger: Five Things To Worry About

    $131.00

    The Takeda/Shire merger will catapult the new company to the “top 10” pharma list, but greater size brings greater challenges, including manufacturing glitches and review issues. Explore the challenges each company brought to the merger and the new ones the merged faces today.

    May 16, 2018
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  • Trump Drug Pricing Plan Includes Part D Surprises, Challenges PBM Business Model

    $200.00

    The Trump Administration’s “Blueprint to Lower Prices and Reduce Out-of-Pocket Costs” includes dramatic changes to protected classes, rebates and PBM reimbursement. Discover why the blueprint has industry leaders worried. Explore the implications for biopharmas and PBMs in particular and the healthcare industry in general.

    May 11, 2018
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  • A World Without Rebates: Is FDA’s Gottlieb Offering New Vision?

    $200.00

    Will drug rebates become illegal? U.S. FDA Commissioner Scott Gottlieb has suggested as much, and PBMs, among others, are paying close attention. Explore the implications–especially for PBMs–and find out why this is historically such a hot-button policy issue.

    May 9, 2018
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  • US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

    $200.00

    The U.S. FDA’s reorganization of its Office of New Drugs (OND) faces leadership challenges, thanks to recent departures. How will the FDA staff these new divisions? Learn more about the departures, gain insights into the agency’s options, and explore the implications for the industry.

    May 1, 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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