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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.

Tecentriq gains first IO approval in triple negative breast cancer

Tecentriq gains first IO approval in triple negative breast cancer

The green light comes via an accelerated approval based on progression-free survival (PFS), and Roche must follow up with a trial confirming the treatment’s overall survival benefits. ... This accelerated approval is based on data from the phase 3

Latest news

  • BioMarin prepares for haemophilia A gene therapy data readout, filing BioMarin prepares for haemophilia A gene therapy data readout, filing

    However Valrox is undoubtedly generating the most anticipation, and the company says it now expects to submit it to the FDA via a potential accelerated approval, which it must apply for ... Bienaimé says the company will decide in the second half of

  • More good news, and some bad, for Merck’s Keytruda More good news, and some bad, for Merck’s Keytruda

    The application is for accelerated approval based on the results of the KEYNOTE-158 trial, which showed that Keytruda, given as a monotherapy to SCLC patients whose cancer had progressed despite ... Keytruda was given accelerated approval by the FDA for

  • EMA says Lilly’s Lartruvo should not be prescribed EMA says Lilly’s Lartruvo should not be prescribed

    First time EMA has acted on accelerated approval follow-up. The EU'S medicines regulator says doctors should stop prescribing Eli Lilly’s soft tissue cancer drug Lartruvo to new patients, ... because it failed a phase 3 trial intended to back up its

  • FDA expecting boom in cell and gene therapies FDA expecting boom in cell and gene therapies

    It intends to make “maximum use” of expedited regulatory pathways, including the regenerative medicine advanced therapy (RMAT) designation and accelerated approval, particularly for products that offer potential cures for diseases with

  • EMA sees approval numbers rise in 2018 EMA sees approval numbers rise in 2018

    The FDA’s faster approval rate is based on its sustained efforts to identify promising innovative drugs earlier, and work more closely with developers, via pathways such as the FDA Breakthrough ... Four medicines gained approval in 2018 following

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Latest Intelligence

  • 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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Latest from PMHub

  • 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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