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Ibrutinib shown to be superior to chlorambucil in trial

7 December 2015 | By Victoria White

Janssen-Cilag International NV has announced data from the Phase 3 RESONATE-2 (PCYC-1115) trial that show ibrutinib (Imbruvica) was superior to chlorambucil in all efficacy endpoints measured in patients with treatment-naïve chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older.

Amgen submits MAA for biosimilar ABP 501 to the EMA

4 December 2015 | By Victoria White

Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...

NICE says ‘no’ to asfotase alfa in draft guidance

3 December 2015 | By Victoria White

NICE has published draft guidance as part of its highly specialised technologies programme that does not recommend Alexion’s asfotase alfa for treating paediatric-onset hypophosphatasia...