Industry news

  1. Kalydeco (ivacaftor) now approved in Canada for children aged 1-2

    Based on promising results from phase III clinical trials, Health Canada has decided to extend the use of Kalydeco (ivacaftor) to include children aged 1 to 2 years. 

    toddler in park with bubles

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  2. Children with cystic fibrosis have a chance to breathe easier

    A recent clinical trial indicates that Symkevi/Symdeko (tezacaftor/ivacaftor) can safely and effectively loosen thick, sticky mucus for children 6-11 years old.

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  3. Lung cancer medicine receives positive opinion in the EU

    CHMP's assessment supports EMA's approval of non-small cell lung cancer (NSCLC) medicine, Vizimpro (dacomitinib).

    EU approval OK hand gesture

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  4. New cancer medicine targets tumour biomarkers anywhere in the body

    The new site-agnostic cancer medicine, Vitrakvi (larotrectinib), gets accelerated approval from the U.S. Food and Drug Administration (FDA).

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  5. New study supports FDA's decision to approve Copiktra (duvelisib)

    Phase III trial shows that Copiktra (duvelisib) may be an option for patients with relapsed or refractory chronic lymphocytic leukaemia and small lymphocytic lymphoma.

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  6. Cancer medicine, Lartruvo (olaratumab), does not prolong life

    After failing to show a clear benefit over chemotherapy on its own, both the FDA and EMA do not recommend Lartruvo (olaratumab) for use in combination with chemotherapy for new STS patients.

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  7. Onpattro (patisiran): the first RNAi therapeutic approved in the European Union

    Onpattro (patisiran) is a first-in-class treatment that slows down the progression of hereditary transthyretin amyloidosis (hATTR).

    EU approval OK hand gesture

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  8. Erleada (apalutamide) gets positive opinion from the EMA

    New medicine shows statistically significant improvements for prostate cancer patients.

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  9. Truxima (rituximab) gains FDA approval as the first biosimilar for Non-Hodgkin's Lymphoma

    A new biosimilar, Truxima (rituximab), shows comparable results to the reference medicine, Rituxan (rituximab), and takes FDA one step further toward expanding patient access to medicines.

    approved stamp with stars

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  10. Vyndaqel (tafamidis) prolongs life of FAP patients

    Positive news for patients with early-stage FAP; results from a Portuguese study show that a liver transplant or Vyndaqel may extend survivability.

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