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accelerated approval

This page shows the latest accelerated approval news and features for those working in and with pharma, biotech and healthcare.

Better together when buying medicines? Taking stock of the BeNeLuxA initiative

Better together when buying medicines? Taking stock of the BeNeLuxA initiative

The price negotiations started in February 2018, eight months after marketing authorisation came from the EMA for Spinraza, following EMA’s accelerated approval process. ... Biogen said it worked with BeNeLuxA for 18 months to secure the deal, engaging

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  • AstraZeneca: building a new ‘open innovation’ pharma company AstraZeneca: building a new ‘open innovation’ pharma company

    Two of these five new launches received accelerated approval, confirming their innovative status, plus the firm also clocked up 14 other regulatory approvals across indication expan- sion and LCM projects in

  • Chinese biotech’s global ambitions Chinese biotech’s global ambitions

    has just achieved a landmark approval in China for its own ‘home-grown’ cancer medicine. ... BeiGene is preparing to submit in the first half of 2019 a New Drug Application (NDA) to pursue an accelerated approval of zanubrutinib for WM patients.

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    During 2016, special approval procedures like conditional and accelerated approval pathways were issued for seven of the new approvals in the EU, the majority in oncology and for orphan diseases. ... In 2016 special approval pathways and designations

  • Curbing the rise of drug resistance Curbing the rise of drug resistance

    Microbes have an extraordinary capacity for developing resistance, accelerated by the over-use of anti-microbials in clinical and agricultural practice. ... Therapeutic areas such as oncology have already enjoyed accelerated approval times to jump

  • Oncology drugs under AMNOG: part two Oncology drugs under AMNOG: part two

    of Xalkori, below - the drug can achieve accelerated approval on the basis of an interim analysis or phase II data before OS is established. ... the tumour shows an excess of a particular biomarker, accelerated approval meant that no clinically

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  • A stumble, but not a fall – what’s next for Opdivo?

    The  immuno-oncology  treatment won an accelerated FDA approval for metastatic melanoma in December 2014, and has since proved to be a thriving sensation. ... Rubbing salt into BMS’s wounds, Merck's  Keytruda snagged a new FDA approval in

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