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AstraZeneca PLC (AZN.L)

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22 Jul 2016
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Latest Key Developments (Source: Significant Developments)

Celgene in Collaboration with AstraZeneca Announce Initiation of Fusion Clinical Development Program in Immuno-Oncology
Monday, 7 Dec 2015 07:30am EST 

Celgene Corp and AstraZeneca:Announced the initiation of the FUSION clinical development program of durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) in hematologic disorders.FUSION program is part of a strategic collaboration with AstraZeneca and its global biologics research and development arm MedImmune, to develop and commercialize durvalumab across a range of blood cancers including non-Hodgkin's lymphoma, myelodysplastic syndromes and multiple myeloma.  Full Article

AstraZeneca PLC presents positive update on Lesinurad Renal Data in Gout Patients
Monday, 9 Nov 2015 08:00am EST 

AstraZeneca PLC:Says presents positive update on lesinurad renal data in gout patients.Says the prescription drug user fee act (pdufa) target goal date for lesinurad is December 29, 2015.Says renal related adverse events increased with decreasing renal function irrespective of lesinurad treatment.  Full Article

Igenica Biotherapeutics enters into a strategic oncology research agreement with AstraZeneca PLC's MedImmune
Wednesday, 28 Oct 2015 08:30am EDT 

Igenica Biotherapeutics:Has entered into an oncology research agreement with MedImmune, the global biologics research and development arm of AstraZeneca Plc.Says Igenica will contribute its proprietary anti-sail antibodies, including ign786, and its proprietary snap adc drug linker.Medimmune will receive an option to an exclusive worldwide license to anti-sail antibodies and antibody-drug conjugates.Says Medimmune will fund all development and commercialization costs under a license agreement.Says Igenica will receive an exclusive option fee and also eligible to receive an upfront license fee, milestones and royalties.  Full Article

AstraZeneca PLC opens new $224 mln drug factory in Russia - Reuters
Monday, 19 Oct 2015 08:00pm EDT 

AstraZeneca PLC:AstraZeneca opened a new $224 million drug manufacturing and packaging factory in Russia on Tuesday in a move Chief Executive Pascal Soriot said reinforced its long-term commitment to the country - Reuters.In 2011, the British-based group was one of the first multinational companies to announce plans to step up medicine production in Russia following moves by Moscow to support local industry by imposing tougher rules on imported drugs - Reuters.It is the largest foreign investment in the construction of a new pharmaceutical facility in the country - Reuters.The company said the plant in the Kaluga region southwest of Moscow would reach full capacity in 2017 and would produce about 40 million packs and 850 million tablets of some 30 medicines every year - Reuters.  Full Article

AstraZeneca PLC Receives Complete Response Letter from US FDA for SaxaGLIPTIN / dapaGLIFLOZIN Fixed-Dose-Combination
Thursday, 15 Oct 2015 08:00pm EDT 

AstraZeneca PLC:Says US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the investigational fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adult patients with type 2 diabetes.Says The CRL states that more clinical data are required to support the application.This includes clinical trial data from ongoing or completed studies and may require information from new studies.AstraZeneca will work closely with the FDA to determine the appropriate next steps for the NDA and remains committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination.  Full Article

AstraZeneca PLC diabetes drug combination faces delay after FDA rebuff - Reuters
Thursday, 15 Oct 2015 08:00pm EDT 

AstraZeneca PLC:U.S. health regulators declined to approve a fixed-dose diabetes drug combination from AstraZeneca, delaying its launch and dealing a blow to an important plank of the drugmaker's business - Reuters.AstraZeneca said on Friday it had received a so-called complete response letter from the Food and Drug Administration (FDA) stating that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin - Reuters.Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval and the move means AstraZeneca faces an unspecified wait in getting its potential blockbuster drug cocktail to market - Reuters.Deutsche Bank analyst Richard Parkes said the FDA move probably reflected lack of data on the new formulation rather than safety or efficacy concerns and it seemed likely a launch would simply be delayed by between 12 and 24 months - Reuters.Morgan Stanley analysts said a best-case scenario was an 8-10 months' delay but this could extend to a few years if new clinical trials were needed - Reuters.The individual component drugs in the new mix are already approved and marketed for the treatment of type 2 diabetes, under the brand names Onglyza and Farxiga, and the FDA move is not expected to affect their status, the company added - Reuters.  Full Article

AstraZeneca buys manufacturing facility in U.S. from Amgen-Reuters
Friday, 11 Sep 2015 02:04am EDT 

Astrazeneca Plc:Purchases US biologics manufacturing facility to support growing pipeline-Reuters.Purchase of a high-tech biologics bulk manufacturing facility from Amgen inc.  Full Article

AstraZeneca to invest in oncology bioinformatics collaboration-Reuters
Tuesday, 8 Sep 2015 02:28am EDT 

AstraZeneca Plc:To invest 11.5 million pound in new clinical oncology bioinformatics collaboration with the University of Manchester-Reuters.  Full Article

AstraZeneca PLC US FDA approves expanded indication for brilinta
Friday, 4 Sep 2015 03:00am EDT 

AstraZeneca PLC:Says US Food and Drug Administration (FDA) has approved BRILINTA (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year.Says With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.  Full Article

AstraZeneca enters license agreement with Daiichi Sankyo
Wednesday, 2 Sep 2015 03:10am EDT 

AstraZeneca PLC:AstraZeneca enters license agreement with Daiichi Sankyo for development and commercialisation of Flumist in Japan.Daiichi Sankyo will take on full responsibility for future development and commercialisation of Flumist Quadrivalent in Japan and will hold marketing authorisation.AstraZeneca will supply Flumist Quadrivalent to Daiichi Sankyo Daiichi Sankyo will pay AstraZeneca upfront fee with subsequent development milestones and sales-related payments post launch Agreement does not impact AstraZeneca's financial guidance for 2015.  Full Article

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AstraZeneca's lung cancer drug meets main goal in late-stage trial

AstraZeneca Plc said its experimental lung cancer drug Tagrisso met its main goal in a late-stage study.