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  • Biomedtracker

    Clinical Trials Industry Report

    By KNect365 17 Aug 2018

    Clinical trials are continually evolving, particularly in light of increasing pressures from new technologies and other disruptors. Trends ranging from artificial intelligence (AI) and mHealth to patient-centricity are challenging the industry to innovate against the backdrop of looming regulatory changes and shifting competitor landscapes resulting from M&A activity. In order to explore these trends, KNect365 Life Sciences recently conducted one of the biggest surveys of its kind across clinical trial professionals from within pharma, CROs, sites, service providers, academia and patient groups across the world to look beyond the hype.

    Topic clinical-trials clinical-trial-optimization

  • Pharma Consulting

    Changing the future of data

    17 Aug 2018

    With fewer successful drug launches in the market and expiring patents, competitive intelligence and commercial R&D decision makers are hard-pressed to make sound forecasting and planning decisions based on highly reliable data analysis. That’s a big challenge because, even with access to big data from many sources, the tasks associated with collecting, organizing and mapping data sets is time-consuming, costly and labour-intensive. As result, decision making takes longer and innovation suffers.

    Topic business-strategies company-analysis

  • Scrip:世界の医薬品産業ニュースサービス

    Amicus' Oral Fabry Drug Priced To Compete Against Traditional ERT

    17 Aug 2018

    FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.

    Topic FDA

  • Scrip:世界の医薬品産業ニュースサービス

    Sensyne Health CEO Drayson Says IPO Will See AI Group To Profitability

    By sten-stovall 17 Aug 2018

    Flush with IPO funding, AI-focused healthcare technology group Sensyne Health will now ready additional products and find three more NHS trust partnerships. CEO Lord Drayson spoke to Scrip.

    Topic research business-strategies

  • Medtech Insight:世界の医療機器に特化したニュース配信

    QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like

    17 Aug 2018

    US FDA will face high hurdles as it works to write a new rule that would merge the agency's Quality System Regulation with international quality systems standard ISO 13485. That's according to Kim Trautman, a longtime industry insider who wrote the QSR in the early to mid-1990s. "It’s a clear heavy lift from a regulatory policy perspective" that could take as long as five years to complete, she says. In the meantime, Trautman offers some insight into what device-makers might see in a new hybrid quality systems regulation from FDA. She addresses everything from corrective and preventive action (CAPA) to labeling, and complaint handling to risk management – and more.

    Topic fda

  • Medtech Insight:世界の医療機器に特化したニュース配信

    Pre-Certs, Test Groups And More: US FDA Outlines Possible New Dx Paradigm

    17 Aug 2018

    The agency has responded to a draft diagnostics reform bill in Congress with proposed reforms that diverge some ways from the proposed legislation, but stick with the underlying goal of completely remaking how lab tests, including test kits and lab-developed tests, are regulated. The agency has put forward a proposal to establish a pre-certification process for test developers, divide most tests into high- or low-risk categories (but exempt many from pre-market review) and remove the concept of substantial equivalence.

    Topic fda

  • Rose Sheet:化粧品とサプリメントに関する規制ニュース

    GC3 Announces Preservative Challenge Winners

    17 Aug 2018

    Avisco, a biotech startup focused on the antimicrobial properties of the Inula viscosa plant, and IMD Natural Solutions, whose INS Glycolipid mushroom extract purportedly is “up to 80 times more effective than traditional preservatives,” are among winners named Aug. 6 by GC3.

    Topic biopharmaceutical

  • In Vivo : 医薬品・医療機器業界の経営層を対象としたニュース

    True Innovation In Women's Health Hindered Because Conditions Are Not Fatal

    17 Aug 2018

    Drug developers and financiers discuss the biggest challenges delaying novel R&D in diseases effecting only women and how poor awareness of the debilitating symptoms that come with some conditions has led to a lack of emphasis on innovative research.

    Topic drug-approval drug-review

  • Biomedtracker

    Biomedtracker 2018 Early Outlook Report

    15 Aug 2018

    What's on the horizon for pharma in 2018? Find out with Biomedtracker's Early 2018 Outlook Report extract. Download free extracts from this essential report, which investigates the catalysts expected to occur in the first part of the year for 21 different drugs.

    Topic Drug development landscape

  • Biomedtracker

    Biomedtracker Q3 2018 Outlook Report Extract

    15 Aug 2018

    Download an extract of the data-rich resource: Biomedtracker’s Q3 2018 Outlook Report. This latest installment in Biomedtracker’s ongoing quarterly reports contains expected drug catalyst predictions, important clinical and regulatory milestones, and Large Impact catalysts for the upcoming quarter. 

    Topic Drug development landscape

  • Meddevicetracker

    Meddevicetracker Q3 2018 Outlook Report Extract

    14 Aug 2018

    In this report, we cover catalysts from 10 devices expected to occur in Q3 2018. These include important regulatory milestones and trial data across the cardiovascular, neurology,  and endocrine (including diabetes) spaces. Additionally, at the end of this report we have included a list of Large Impact catalysts through Q3 2018.

  • Scrip:世界の医薬品産業ニュースサービス

    Perrigo Looks To Spin Out Or Sell Off Rx Business, But Will Separating Generics Add Value?

    By Mandy Jackson 14 Aug 2018

    Perrigo previously saw value in keeping its prescription pharmaceuticals in-house, but now says it will sell off or spin out the topical generics to focus on its over-the-counter brands. Questions remain about whether the company's generics portfolio is valuable enough to stand alone or attract a buyer.

    Topic business-strategies drug-approval

  • Scrip:世界の医薬品産業ニュースサービス

    A Safe Harbor For Biotechs Ascletis BeiGene Mark Early Wins For HK Exchange

    By Jules Quartly 14 Aug 2018

    The market debuts of BeiGene and Ascletis on the new Hong Kong Stock Exchange’s Biotech section could further encourage other Chinese biotech companies as they seek to draw in a wider pool of investors and focus on the promising domestic sector.

    Topic Business strategies Company analysis

  • Pink Sheet:世界の薬事規制と承認審査に関するニュース

    US FDA’s Breakthrough And RMAT Designations: A Quick Guide

    By Bridget Silverman 14 Aug 2018

    Differences in eligibility and evidentiary criteria between the US FDA's two expedited regulatory programs are reflected in a new guide; metrics to date suggest comparable success rates for designation requests under the two programs. Our infographics aid in understanding the programs.

    Topic fda

  • In Vivo : 医薬品・医療機器業界の経営層を対象としたニュース

    Cancer's New Patient Demographic; Will Survivorship Change The Face Of Cancer Care?

    By William Looney 13 Aug 2018

    The 16 million survivors of cancer in the US today form a restless constituency with its own disparate set of interests – and by sheer weight of numbers is beginning to direct changes to medical practice that pose both risks and opportunity for biopharma.

    Topic cancer


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