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 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).
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...
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…
3 May 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) to treat metastatic urothelial carcinoma...
27 April 2017 | By Niamh Marriott, Junior Editor
The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
The annual Drugs to Watch report forecasts that eight new drugs will enter the market in 2017 and achieve blockbuster sales of more than $900 billion by 2021...
6 April 2017 | By Niamh Marriott, Junior Editor
In a trial carried out at Imperial College, researchers showed that women who suffered seven or more hot flushes a day could reduce the number by 73%...
4 April 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has granted full approval for AstraZeneca’s Tagrisso (osimertinib) tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR…
30 March 2017 | By Niamh Marriott, Junior Editor
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the European Medicines Agency (EMA) has granted orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
17 March 2017 | By Niamh Marriott, Junior Editor
AstraZeneca’s Phase III SOLO-2 trial demonstrated a significant improvement in progression-free survival (PFS) in germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients treated with Lynparza (olaparib) tablets (300mg twice daily) compared with placebo in the maintenance setting. The trial met its primary endpoint of investigator assessed PFS (HR 0.30; 95%…
23 February 2017 | By Niamh Marriott, Digital Editor
AstraZeneca announced positive results from its Phase III trial comparing Lynparza to chemotherapy, to treat HER2-negative metastatic breast cancer...
In this NIR In-Depth Focus: Monitoring and controlling drug products and manufacturing processes with NIRS; Development of a NIRS method for quantification of a minor polymorphic form; and an Expert View with Metrohm Process Analytics...
8 February 2017 | By Brian White and Paul Taylor, Healthcare Analysts, Cantor Fitzgerald Europe
Healthcare analysts predict another difficult year ahead for the pharmaceutical giant, after 2016 was beset with competitive and pricing pressures...
European Pharmaceutical Review has been keeping the industry informed for 21 years and continues to bring insights into current and emerging technologies, contributions from recognised figures in the life science community and of course, the latest and most up to date news. To celebrate our success, we will be counting down…
23 November 2016 | By Niamh Louise Marriott, Digital Content Producer
The Phase III KESTREL trial has already re-opened for new patient enrolment at some clinical study sites and the EAGLE trial is expected to resume shortly....
14 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Read how the 2016 Access to Medicine Index ranks the top 20 pharmaceutical companies on their efforts to improve access to medicine in low- and middle-income countries...