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Capecitabine

NICE does not recommend tucatinib in new draft guidance

26 October 2021 | By Anna Begley (European Pharmaceutical Review)

The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.

Doctor in white coat holding pink ribbon - symbol of breast cancer

news

UK grants marketing authorisation to “landmark” breast cancer therapy

22 February 2021 | By Hannah Balfour (European Pharmaceutical Review)

Seagen's Tukysa® (tucatinib) was approved in the UK as part of a combination regimen for the treatment of adults with locally advanced or metastatic HER2-positive breast cancer.

news

EMA begins safety review of ifosfamide cancer medicines

16 March 2020 | By Victoria Rees (European Pharmaceutical Review)

The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.

article

ICH M9: biopharmaceutics classification system-based biowaivers

18 December 2019 | By Dave Elder (JPAG Member and David P Elder Consultancy)

ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…

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