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FDA rejects AstraZeneca’s Farxiga treatment
AstraZeneca has been issued with a complete response letter for Farxiga by the FDA meaning that it has rejected the treatment.
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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 grants Orphan Drug Designation to Imfinzi for SCLC
The FDA has announced Orphan Drug Designation for Imfinzi (durvalumab) to treat small cell lung cancer in combination with other therapies.
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Decision by NICE for the use of osimertinib to be appealed
A pharmaceutical company will appeal a decision by NICE to not recommend osimertinib for use within NHS England.
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Fasenra receives positive EU CHMP opinion for self-administration and the new Fasenra pen, a pre-filled, single-use auto-injector
AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to add a self-administration option for Fasenra (benralizumab) and a new delivery method as a pre-filled, single-use auto-injector (the Fasenra pen) to the medicine’s product information in the European…
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Digital design for pharmaceutical product and process development
New digital design and manufacturing techniques offer pharmaceutical manufacturers the possibility of a systems-based, digital approach to substantially streamline their design, development and manufacturing processes. The ADDoPT collaborative consortium has been working to explore how emerging process understanding and predictive models can be applied and embedded within industrial workflows to…
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Lynparza has been approved for BRCA-mutated advanced ovarian cancer
BRCA-mutated advanced ovarian cancer treatment has been approved by the European Commission.
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Formulation, Development & Delivery In-Depth Focus 2019
This in-depth focus looks into industrial workflow processes and also how nature can provide inspiration for drug delivery.
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Ten big pharma companies collaborate on data sharing AI
A new AI project marks the first time 10 pharmaceutical companies have agreed to share data to aid drug discovery.
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It’s not just about the science: microbiological analysis
Modernisation of microbiological test methods involves far more than just the science. As new systems and technologies become available it becomes increasingly important that potential users can identify not only the technical requirements, but also the business case. Here, Paul Newby, Alice Laures and Lisa Wysocki from GlaxoSmithKline discuss criteria…
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Continuous wet granulation manufacturing collaboration
The new facility, built as part of a project called PROSPECT CP, will include blending and feeding of raw materials, twin screw wet granulation, drying and ultimately tabletting...
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Vaccine facility targets development and manufacturing to fight pandemics
The new hub is designed to speed the response to deadly pandemics by improving the development and manufacturing of vaccines – particularly in low- and middle-income countries...
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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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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...
