Tag Archives: Sean Bohen

AstraZeneca and Amgen announce US FDA Breakthrough Therapy Designation for tezepelumab in patients with severe asthma

AstraZeneca’s first Breakthrough Therapy Designation for a respiratory medicine Designation based on Phase IIb PATHWAY data that demonstrated tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma CAMBRIDGE, 12-Sep-2018 — /EuropaWire/ — AstraZeneca and its partner Amgen Inc. (Amgen) … Read the full press release

AstraZeneca and MedImmune present results from Phase III clinical trial of moxetumomab pasudotox in patients with hairy cell leukaemia

Trial meets the primary endpoint of durable complete response Majority of patients who had a complete response had no evidence of any remaining detectable cancer cells Phase III clinical trial results served as basis for recent US FDA regulatory submission … Read the full press release

AstraZeneca Phase III PACIFIC trial: Imfinzi demonstrated statistically-significant and clinically-meaningful improvement in PFS

Imfinzi improves progression-free survival (PFS) by more than 11 months compared to standard of care and is the first medicine to show superior PFS in this setting Data presented at the ESMO 2017 Congress follows FDA’s recent Breakthrough Therapy Designation … Read the full press release

AstraZeneca Phase III FLAURA trial supports Tagrisso’s potential as a new standard of care in 1st-line EGFR-mutated lung cancer

Phase III FLAURA trial results show Tagrisso reduced the risk of progression or death by more than half, with consistent benefit across all subgroups, including patients with and without brain metastases Unprecedented median progression-free survival (PFS) of 18.9 months compared … Read the full press release

Acerta Pharma: US FDA accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib inhibitor

CAMBRIDGE, 07-Aug-2017 — /EuropaWire/ — AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib, … Read the full press release