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New FDA guidance for cells, tissues

Country: United States

The US Food and Drug Administrations has issued four guidance documents explaining how it intends to regulate products derived from human cells and tissues. The guidance updates rules that first took effect in 2005 and includes new incentives for developers of potentially life-saving therapies.

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Ablynx provides nine-month update

Country: Belgium

Ablynx NV, the Belgian antibody specialist, has released financial results for the first nine months of 2017 which show an operating loss due to significant outlays for research and development, but a strong cash balance. This was later augmented by a successful IPO on US Nasdaq.

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Partnership seeks in vivo gene editing

Country: Switzerland

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New drug for CMV after transplants

Country: United Kingdom

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Roche MS drug recommended by EMA

Country: United Kingdom

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Patrick Vallance to become UK chief scientific adviser

Country: United Kingdom

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Higher operating profit at AZ

Country: United Kingdom

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Lundbeck results disappoint, management in transition

Country: Denmark

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Evotec grows in Q3 but profit slips

Country: Germany

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MorphoSys reports big third quarter loss

Country: Germany

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Swiss NousCom raises €42 million

Country: Switzerland

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European company financings spurt ahead

Country: United Kingdom

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Assessing the threat from drug-resistant bacteria by Jennifer Schneider

AntibioticReviewJennifer SchneiderOct2017.pdf

Highlights of the October 2017 MedNous issue

The October 2017 MedNous features:

Latest Mednous cover
  • Business Strategy
    Detecting cancer
    using liquid biopsy
  • Antibiotic Review
    Assessing the threat from
    drug-resistant bacteria
    By Jennifer Schneider
  • Research Strategy
    Building multifunctional
    biologics to treat disease
    By Brian McGuinness and
    Peter Pack
  • Regenerative Medicine
    Regulatory challenges for
    cell therapy manufacture
    By Adeyemi Afuwape and Tim Farries
  • Biotech Financing
    Underinvested Europe has boost,
    but Nasdaq calls

The latest MedNous journal. Subscribe to download.