Astrazeneca

- Read more about Durvalumab granted Breakthrough Therapy designation by US FDA
AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.
- Read more about Allergan Collaborate with AstraZeneca to Develop and Commercialize ATM-AVI
Allergan plc announced that it has entered into a global agreement with AstraZeneca to develop and commercialize ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and avibactam. Together, the two companies will evaluate the combination to treat serious infections caused by metallo βlactamase MBL-producing Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant Enterobacteriaceae (CRE), for which there are currently very limited treatments, thus presenting a new treatment option for patients with MBL-producing pathogens. Under the terms of the agreement, Allergan will maintain commercialization rights in the U.S. and Canada and AstraZeneca will maintain commercialization rights in all other countries.
- Read more about AstraZeneca Together with GSK, J& J and academia to establish translational research fund
AstraZeneca together with GlaxoSmithKline and Johnson & Johnson has partnered with three world-class universities, Imperial College London, the University of Cambridge and University College London (UCL), to create the Apollo Therapeutics Fund. This pioneering new consortium aims to convert outstanding academic science from the three universities into innovative medicines for a broad range of diseases.
- Read more about FDA approves Zurampic to treat high blood uric acid levels associated with gout
The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.
- Read more about Brilique receive positive opinion of EMA committee for extended treatment of patients with history of heart attack
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Astrazeneca's Brilique (ticagrelor) 60mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti platelet therapy.

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- Read more about EMA committee recommends marketing approval for AstraZeneca's Tagrisso
AstraZeneca, a global, science-led biopharmaceutical business, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets 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).
- Read more about AstraZeneca enters into agreement with Perrigo for rights to Entocort® in the US
AstraZeneca announced that it has entered into an agreement with Perrigo Company plc for the divestment of US rights to Entocort® (budesonide), a gastroenterology medicine for patients with mild to moderate Crohn’s disease, an area of medicine outside AstraZeneca’s strategic focus.
- Read more about AstraZeneca inks 3 technology partnerships to strengthen its Cambridge lead discovery centre
AstraZeneca, a global, innovation-driven biopharmaceutical business, announced three new partnerships that will deliver industry-leading technologies to drive the AstraZeneca MRC UK Centre for Lead Discovery in the search for novel small molecule medicines. The partnerships will ensure state-of-the-art screening and compound management at the facility, which will be located within the company’s new global R&D centre at the Cambridge Biomedical Campus. It will screen around 2 million chemical structures per target to find new compounds for disease targets.
- Read more about FDA grants approval for Tagrisso (AZD9291) to treat patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved TAGRISSO (AZD9291) 80mg once-daily 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, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
- Read more about AstraZeneca presents positive new data on anifrolumab in lupus
AstraZeneca, along with its global biologics research and development arm, MedImmune, will present positive data today from the Phase II trial of anifrolumab for the treatment of moderate-to-severe systemic lupus erythematosus (SLE or lupus) at the American College of Rheumatology (ACR) 2015 Annual Scientific Meeting in San Francisco.