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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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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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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).
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Lynparza significantly reduces risk of disease worsening or death
8 June 2017 | By Niamh Marriott, Junior Editor
AstraZeneca's positive results from its trial that showed a statistically-significant and clinically-meaningful improvement in progression-free survival...
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New medicine shows potential to reduce oral steroid use in severe asthma patients
26 May 2017 | By Niamh Marriott, Junior Editor
A trial led by a McMaster University respirology professor shows promising results for a new medicine for severe asthma patients.
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Brilique (ticagrelor) new formulation gains European approval
25 May 2017 | By Niamh Marriott, Junior Editor
The European Commission has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new formulation...
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AstraZeneca enters agreement with Recordati for Seloken in Europe
24 May 2017 | By Niamh Marriott, Junior Editor
AstraZeneca has entered into an agreement with Recordati for the commercial rights to Seloken/Seloken ZOK treatments in Europe...
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Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research
16 May 2017 | By European Federation of Pharmaceutical Industries and Associations (EFPIA)
The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with quality medicines
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Inducing protein aggregation by extensional flow makes drugs less effective
9 May 2017 | By University of Leeds
Data from a new device demonstrates maximal levels of extensional flow which manufacturers could use for different processes, without damaging proteins...
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Roche receives FDA approval for bladder cancer biomarker assay
5 May 2017 | By Niamh Marriott, Junior Editor
The FDA has approved Roche’s biomarker assay as a complementary diagnostic to provide PD-L1 status for patients with urothelial carcinoma...
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AstraZeneca’s new formulation tablets receive positive CHMP opinion
5 May 2017 | By
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the adoption of AstraZeneca’s Brilique (ticagrelor) 90mg orodispersible tablets (ODT) as a new method of treatment administration. This opinion is the first step towards the adoption of a new…
