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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Big Pharma CEOs Get Ready To Testify: Preparing For A No-Win Situation

    $131.00

    Leading pharmaceutical executives called to testify before a Senate Finance Committee hearing on drug prices were likely the first of many to be summoned. It’s a no-win situation, but preparation can help. Find out why changing the subject can be a smart tactic. Discover how some senators may try to lure execs into inadvertently lying–and learn how to avoid it.

    May 13, 2019
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  • Biogen CMO Notes iPhone’s Potential For Early Detection of Alzheimer’s

    $100.00

    Biogen’s chief medical officer says iPhone technology should in future be used for early warning diagnosis of Alzheimer’s Disease. Biogen CMO Alfred Sandrock has told a London neuroscience forum that constraints impeding CNS drug development include the fact diagnosis needs to be done earlier but that barrier could be mitigated in future by digital health solutions such iPhones used as “early warning” diagnostics, notably in Alzheimer’s Disease.

    February 5, 2018
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  • BioMarin Is Carrying The Biggest Target On Its Back, Morningstar Says

    $200.00

    Expect more industry consolidation, counsels Morningstar’s Healthcare Observer report. Among the potential deals: BioMarin is a logical acquisition target. But for whom? Find out what Morningstar’s Damien Conover predicts. Discover which companies could be targets for Pfizer, and learn what Conover thinks of Pfizer CEO Albert Bourla’s insistence that it plans to grow organically.

    February 18, 2019
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  • Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting

    $200.00

    Is a suffix that distinguishes biosimilars and other biologic products necessary in adverse event reporting? The US FDA says yes, although to date, nearly every adverse event report received by the FDA have identified biosimilars simply by their brand names.

    October 10, 2018
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  • Biotech CEOs: Can Scientist-Founders Remain In Charge?

    $200.00

    Founder-CEOs do not typically remain at the helm as biotechs mature, as the majority of scientist-founders lack the skills to lead a company beyond discovery and early development. Exceptions to that rule are multiplying, though, especially in Europe as companies aim directly for Nasdaq. In this fascinating read, In Vivo reviews the many, varied paths toward biotech CEO, and what it takes to lead a company to IPO and beyond.

    May 20, 2019
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  • Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

    $200.00

    Several drugs recently lost their Breakthrough Therapy Designations (BTDs), and Pink Sheet has identified others in the pipeline that might suffer the same fate soon. Take a look at the therapies possibly on the chopping block and the reasons behind it in this informative article.

    March 10, 2019
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  • Brexit At The 11th Hour: UK Refreshes No-Deal Guidance For Medtech

    $200.00

    As Brexit looms and a no-deal scenario becomes increasingly a possibility, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated their guidance on how to respond should no deal with Europe be reached. What does it mean for Medtech? Find out here.

     

    January 4, 2019
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  • Bristol-Myers, Celgene and The Perils Of The US Drug Pricing Environment

    $131.00

    Pink Sheet brings you a look at the effects of the Bristol-Celgene merger on the public and political perceptions of the companies, with an examination of how pricing for Revlimid has affected Celgene’s public image and stock pricing.

    January 6, 2019
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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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  • BSI Touts ‘Very Short’ Waiting Times For Migrating Certificates From UK To Netherlands

    $131.00

    UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit in March. Learn what this move would have meant to UK start-ups. Read the MHRA response to a Medtech Insight inquiry about the role of UK notified bodies after Brexit.

    February 5, 2019
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  • Burt’s Bees Hopes Third Time’s A Charm For Toothpaste, This One With P&G

    $131.00

    Burt’s Bees is making another foray into the toothpaste category with a line for adults and children and a strategic licensing partnership with Procter & Gamble, makers of Crest. Discover the details of this third attempt to successfully enter the oral care space by the Clorox-owned Burt’s Bees.

    January 5, 2019
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  • Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 ‘In The Coming Years,’ Official Says

    $131.00

    Global regulators are looking to converge–or at least align–various requirements, and the US FDA is no exception. Officials have strongly suggested that the agency will replace its Quality System Regulation with ISO 13485. It won’t be simple. Discover the implications for device makers, and find out what’s involved in making this dramatic change.

    May 4, 2018
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  • Can Novartis Reclaim Pioneering Role In Transplantation?

    $131.00

    Novartis is developing a new type of immunosuppressive agent, an anti-CD40 monoclonal antibody, which might allow organ transplants to last longer in recipients, reduce pressure on transplant waiting lists, and improve long-term outcomes. In Vivo interviewed Novartis’ Head of Immunology, Hepatology and Dermatology.

    September 2, 2019
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  • Cancer Drug Combination Pricing: Genentech Offers Model For Tecentriq, Avastin

    $131.00

    Go behind the scenes for the details on Genetech’s proposed “Combination Pricing Pilot” plan, which offers a discount for Avastin and Tecentriq when the two drugs are used in conjunction to treat patients with lung cancer. Pink Sheet brings you the details about the proposal, which ties into the company’s Medicare Part B interests.

    January 22, 2019
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  • Cancer’s New Patient Demographic; Will Survivorship Change The Face Of Cancer Care?

    $200.00

    As the number of cancer survivors increases, they are reshaping cancer research and clinical practice. Find out how–and discover the impact it will have on the allocation of research dollars. Learn how the looming physician shortage has implications for the emergence and increasing use of complex immunotherapy drugs.

    August 6, 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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