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EMA accepts Marketing Authorisation Variation for Forxiga in adults with type-1 diabetes
First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes...
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AstraZeneca
AstraZeneca plc is an Anglo–Swedish multinational pharmaceutical and biopharmaceutical company.
In 2013, it moved its headquarters to Cambridge, United Kingdom, and concentrated its R&D in three sites: Cambridge, Gaithersburg, Maryland (location of MedImmune) for work on biopharmaceuticals, and Mölndal (near Gothenburg) in Sweden, for research on traditional chemical drugs. In 2015, it was the eighth-largest drug company in the world based on sales revenue.
AstraZeneca has a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation. The company was founded in 1999 through the merger of the Swedish Astra AB and the English Zeneca Group (itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993). It has made numerous corporate acquisitions, including Cambridge Antibody Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) and Definiens (by MedImmune in 2014).
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FDA expands approval of Imfinzi to reduce the risk of NSCLC progression
The FDA has approved Imfinzi for the treatment of patients with stage III non-small cell lung cancer whose tumours are not able to be surgically removed and whose cancer has not progressed after treatment...
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Tudorza reduces exacerbations in COPD patients
AstraZeneca has announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair in patients with moderate to very severe COPD...
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EMA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated NSCLC
The EMA has accepted a variation to the MAAv for Tagrisso, for the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer...
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FDA approves Fasenra for severe eosinophilic asthma
The FDA has approved Fasenra for the add-on maintenance treatment of patients with severe asthma aged 12 years and older...
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Pursuing great science with MedImmune
As part of EPR’s Women in Pharma series, Dr Jane Osbourn, Vice President of Research & Development, MedImmune, talks to Science Editor Dr Zara Kassam about the importance of breaking through self-imposed barriers…
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FDA approves Bydureon BCise for patients with type-2 diabetes
The FDA has approved Bydureon BCise for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines...
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FDA accepts regulatory submission for Lynparza in metastatic breast cancer
Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer...
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FDA grants breakthrough therapy designation to Tagrisso for NSCLC
The FDA has granted Breakthrough Therapy Designation for Tagrisso for the 1st-line treatment of patients with NSCLC...
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Type 2 diabetes drug provides significant benefits to type 1 diabetic patients
A study has found that a majority of patients with Type 1 diabetes who were treated with dapagliflozin, a Type 2 diabetes medicine, had a significant decline in their blood sugar levels...
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Biopharma stages a strong recovery
After the first half of 2017 biopharma investors are in a position to be exuberant, the threat of US price controls that have overshadowed the sector for a year have largely disappeared...
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FDA grants Breakthrough Therapy Designation status for acalabrutinib
It has been announced that the FDA has awarded AstraZeneca’s acalabrutinib product for MCL treatment Breakthrough Therapy Designation...
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Consortium established to support ICH M7 compliance
An industry work-group comprising of toxicologists, pharmaceutical companies and data experts plans to unveil the early results of a data sharing project...
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Imfinzi wins breakthrough therapy designation
AstraZeneca and MedImmune, have today announced that the US Food and Drug Administration has granted breakthrough therapy designation for Imfinzi for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer...
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NICE approves AstraZeneca’s COPD drug
The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending roflumilast (Daxas, AstraZeneca) for chronic obstructive pulmonary disease (COPD).
