AstraZeneca Pharmaceuticals

AstraZeneca Pharmaceuticals
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CHMP positive recommendation is based on Phase III data demonstrating a 20% reduction in risk of disease worsening or death over anastrozole 23 June 2017 AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing...

Comprehensive updated analysis provides valuable evidence on the safety profile of Farxiga, including no imbalance in lower-limb amputations New analyses from CVD-REAL examine reductions in CV events for SGLT-2 inhibitors, including Farxiga in patients with and without CV disease versus DPP-4 inhibitors 12 June 2017 AstraZeneca presented new data...

Updated safety data on risk-benefit profile of Farxiga (dapagliflozin), three new analyses from the landmark CVD-REAL study, including Farxiga vs DPP-4 inhibitors, and a late-breaking oral presentation reveal further CV evidence across a broad population of patients with type-2 diabetes Data from DURATION-7 and DURATION-8 evaluating efficacy and...

OlympiAD was the first positive Phase III trial to evaluate the efficacy and safety of a PARP inhibitor beyond ovarian cancer Lynparza tablets reduced risk of disease worsening or death by 42% The overall safety profile was consistent with previous trials of Lynparza 4 June 2017 AstraZeneca today presented positive results from its Phase III...

Based on a composite measure of major adverse CV events (MACE), Bydureon did not increase cardiovascular (CV) risk and showed a consistent safety profile Fewer CV events were observed in the Bydureon arm, however, the efficacy objective of reduction in CV risk did not reach statistical significance 23 May 2017 AstraZeneca today announced top-line...

Imfinzi met a primary endpoint of statistically-significant and clinically-meaningful progression-free survival (PFS) in ‘all-comer’ patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer in a planned interim analysis Imfinzi is the first immuno-oncology medicine to show superior PFS in this setting Plans for...

03 May 2017 AstraZeneca today announced a strategic collaboration in respiratory diseases with Pieris Pharmaceuticals, Inc. to develop novel inhaled drugs that leverage Pieris’ Anticalin® platform. Anticalin molecules are engineered proteins which can mimic antibodies by binding to sites either on other proteins or on small molecules. They are...

Approval granted regardless of PD-L1 status, based on tumour response rate and duration of response Imfinzi is the cornerstone in an extensive Immuno-Oncology
programme across multiple cancer types and stages of disease 01 May 2017 AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and...

Full approval follows Tagrisso’s expedited Conditional Marketing Authorisation as first-in-class medicine for patients with locally-advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer Tagrisso is a potential new standard of care in 2nd line and subsequent therapy in this hard-to-treat form of lung cancer Approval is...

Conversion from accelerated to full approval confirms the potential of Tagrisso to become standard of care in the US Approval based on Phase III AURA3 trial that demonstrated significant improvement in progression-free survival with Tagrisso as compared to chemotherapy 31 March 2017 AstraZeneca today announced that the US Food and Drug...