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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.

Abivax’s COVID-19 study declared Research National Priority by French government

Abivax’s COVID-19 study declared Research National Priority by French government

Those clinical trials, including Abivax’s study, that are declared to be a national priority gain access to an accelerated regulatory review and approval process by the French regulatory authorities (ASNM) ... Results from the ongoing study are

Latest news

  • Gilead set to acquire hepatitis specialist MYR for €1.15bn Gilead set to acquire hepatitis specialist MYR for €1.15bn

    It is currently the first and only drug with conditional approval in the EU for HDV. ... In addition to the EMA conditional approval, MYR expects to submit Hepcludex to the US Food and Drug Administration (FDA) for accelerated approval in the second half

  • Jazz Pharma’s SCLC drug fails to meet primary endpoint in combo trial Jazz Pharma’s SCLC drug fails to meet primary endpoint in combo trial

    It won that approval based on prior phase 2 data, announced by PharmaMar at the 2019 American Society of Clinical Oncology congress, which had shown an overall response rate of ... accelerated and/or full regulatory approval of lurbinectedin by the FDA

  • Be careful what you wish for Be careful what you wish for

    So wishing for an accelerated approval, given the trade-off required on safety and efficacy, is simply a bad idea. ... But another reason you don’t want to wish for an accelerated vaccine is a much more subtle and nuanced justification.

  • AstraZeneca’s Imfinzi fails first-line bladder cancer test AstraZeneca’s Imfinzi fails first-line bladder cancer test

    The failed study sets back AZ’s plans to expand Imfinzi into the first-line bladder cancer category, although it has already been granted an accelerated approval in the US for ... Keytruda became the first checkpoint inhibitor to get a green light in

  • IMV preps pivotal trials for ovarian cancer T cell therapy IMV preps pivotal trials for ovarian cancer T cell therapy

    IMV says it is now seeking a meeting with the FDA to try to work out the design of a larger phase 2b trial that could support accelerated approval of ... cyclophosphamide given on its own, which makes a path to regulatory approval unclear.

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Latest Intelligence

  • How will COVID-19 affect uptake of vaccinations against other diseases? How will COVID-19 affect uptake of vaccinations against other diseases?

    A particular threat in this regard could come from the accelerated clinical development programmes and expedited approval processes that are being put in place to push through SARS-CoV-2 vaccines.

  • Surviving cancer: a new era for patients Surviving cancer: a new era for patients

    The FDA recently granted accelerated approval for the ADC trastuzumab-deruxtecan in patients with breast cancer, with progression-free survival (PFS) rates showing that longer life is a real possibility – a

  • The Cystic Fibrosis Buyers’ Club The Cystic Fibrosis Buyers’ Club

    The movement proved to be hugely influential, and by the early 1990s its activism had spurred the FDA to introduce ‘accelerated approval’ that allowed experimental yet promising drugs to be made

  • 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.

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Latest from PMHub

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