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You are here: Home > Opinion & analysis

Opinion & analysis


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  • EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

    $131.00

    Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.

    June 8, 2018
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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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  • 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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  • FDA Plans Consumer Survey To Better Understand Cosmetics Allergy Prevalence

    $131.00

    An FDA 2019 online survey is aimed at collecting data from 1,000 targeted respondents regarding their experiences with allergens in cosmetics. This survey marks the US FDA’s first efforts in four decades to document the possible link between an overall rise in allergies and the cosmetics industry.

    November 7, 2018
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  • Vanda Warning Letter From US FDA Leaves Firm “Puzzled”

    $131.00

    A recent letter to Vanda from the US FDA regarding the firm’s listing of indications without corresponding safety information on the company’s website left Vanda’s CEO confounded as to the reasoning behind this action, even as the firm moved to take corrective action.

    November 5, 2018
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  • US FDA May Largely Avoid House Democrats’ Investigation Agenda

    $131.00

    As Democrats gained a majority in the House after the 2018 US midterm elections, many wonder who will be on their radar when they turn their attention to holding hearings on drug pricing. The answer? It’s not likely to be the FDA.

    November 7, 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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