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AstraZeneca receives FDA complete response letter for PT010
The FDA has given a complete response letter to AstraZeneca for its PT010 treatment, regarding its New Drug Application.
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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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Fast Track designation given to heart failure treatment
Farxiga (dapagliflozin) has been given Fast Track designation by the FDA to reduce the risk of cardiovascular death.
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China grants Tagrisso (osimertinib) marketing authorisation
Following positive clinical trials, the Tagrisso drug has been given marketing authorisation in China for treatment of NSCLC.
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Hitting the target – refining anticancer nanomedicine development
Mahfoozur Rahman and Sarwar Beg explain why we need to change tack from traditional formulation-driven development to a target-based approach in order to increase success with anticancer nanomedicine in the clinic.
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QA/QC & Analytical Techniques In-Depth Focus 2019 featuring Environmental Monitoring
This In-Depth Focus highlights why bio-fluorescent particle detection is an effective method for enumerating present microbes and discusses ICH Q10 knowledge management; presenting five tips for improving your company’s knowledge management.
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Farxiga has been granted Fast Track status by the FDA
Fast Track designation has been granted to Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
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Breztri Aerosphere Phase III trial meets primary endpoints
A clinical trial to study a chronic obstructive pulmonary disease treatment has found that the drug is effective and safe.
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Imfinzi combination fails advanced lung cancer study
A late-stage clinical trial for Imfinzi and an experimental treatment has not extended the lives of patients with advanced non-small cell lung cancer.
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NICE recommends Lokelma treatment for hyperkalaemia
Lokelma, a treatment for hyperkalaemia in adults, has received a positive Final Appraisal Document from NICE after successful trials.
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AstraZeneca and Novartis set to lose out from US drug prices reforms
A report has suggested that the drug price reforms in the US will affect AstraZeneca and Novartis negatively, but Novo could benefit.
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New model could be used to predict shelf life of drugs
Researchers have developed a model that describes how antibody solutions separate into different phases and could be used to anticipate the stability and shelf-life of drugs.
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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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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…
