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AstraZeneca PLC (AZN.L)

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29 Sep 2016
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Latest Key Developments (Source: Significant Developments)

Astrazeneca and Moderna files first clinical trial application in RNA therapeutics
Tuesday, 26 Jul 2016 07:00am EDT 

Astrazeneca Plc : Astrazeneca and Moderna announce filing of first clinical trial application in messenger RNA therapeutics(tm) collaboration .Filed (CTA) with Paul Ehrlich Institute and German Federal Ministry Of Health to initiate a phase 1 clinical trial of AZD8601.  Full Article

AstraZeneca says new diabetes treatment gets European approval
Tuesday, 19 Jul 2016 09:15am EDT 

Astrazeneca Plc :European commission has approved Qtern (saxagliptin/dapagliflozin) tablets for treatment of type 2 diabetes in all member countries.  Full Article

Astrazeneca's lung cancer drug meets primary endpoint in late-stage trial
Monday, 18 Jul 2016 02:00am EDT 

Astrazeneca Plc : Tagrisso met primary endpoint in phase III trial . Objective response rate, disease control rate, duration of response achieved clinically meaningful improvement versus chemotherapy . Phase III Aura3 trial met primary endpoint, demonstrating superior progression-free survival compared to standard chemotherapy . Tagrisso showed superior progression-free survival compared to standard platinum-based chemotherapy .Full evaluation of Aura3 data is ongoing, and results will be presented at an upcoming medical meeting.  Full Article

Fibrogen announces receipt of $62 million license payment from Astrazeneca
Friday, 8 Jul 2016 04:00am EDT 

Fibrogen Inc : Fibrogen announces receipt of $62 million license payment from Astrazeneca .Astrazeneca,Co collaborating on development,commercialization of drug for treatment of Anemia in patients with CKD in U.S., China, other markets.  Full Article

Valeant Pharmaceuticals announces new licensing arrangement for Brodalumab in Europe
Friday, 1 Jul 2016 02:00am EDT 

Valeant Pharmaceuticals International Inc : Valeant Pharmaceuticals announces new licensing arrangement for Brodalumab in Europe . Says affiliate and Astrazeneca have amended Valeant's license for Brodalumab . Amendment for Brodalumab to terminate Valeant's right to develop and commercialize Brodalumab in Europe . Astrazeneca has entered into an agreement granting Leo Pharma exclusive rights to develop and commercialize Brodalumab in Europe . Under terms of amended agreement, Valeant will continue to hold license to develop and commercialize Brodalumab in U.S . As consideration for termination of European rights, Astrazeneca to pay to co an upfront payment and certain sales-based milestone payments .As consideration for termination of European rights, one of pre-launch milestones payable by co to Astrazeneca under original license reduced.  Full Article

U.S. FDA says continues to find benefits of flumist quadrivalent outweigh any potential risks
Tuesday, 28 Jun 2016 01:57pm EDT 

U.S. Food and Drug Administration (FDA): FDA continues to find that the benefits of flumist quadrivalent outweigh any potential risks . Agency has determined that specific regulatory action is not warranted at this time .Continues to work with medimmune to determine cause of lower than expected effectiveness of flumist quadrivalent observed in recent years.  Full Article

AstraZeneca says life sciences competitivess, drug access key after Brexit
Friday, 24 Jun 2016 02:00am EDT 

Astrazeneca Plc : Says would have been better for uk to remain in eu, will now be protracted period of transition . Astrazeneca says aims to safeguard competitiveness of life sciences industry and speed of patient access to innovative medicines Further company coverage: [AZN.L] (Reporting by UK bureau) ((uk.online@reuters.com;)).  Full Article

AstraZeneca confirms CDC interim recommendation on flu vaccine
Thursday, 23 Jun 2016 02:00am EDT 

Astrazeneca Plc :Confirmed that ACIP center of CDC has provided interim recommendation on use of flumist quadrivalent live attenuated influenza vaccine.  Full Article

Adherium says Astrazeneca will use its Smartinhaler platform in US clinical study
Monday, 13 Jun 2016 06:16pm EDT 

Adherium Ltd : Astrazeneca will use its smartinhalertm platform in US clinical study on patients with chronic obstructive pulmonary disease .  Full Article

EU health agency recommends approval of new hepatitis C drugs
Friday, 27 May 2016 07:21am EDT 

EU Medicines Agency : EU Medicines Agency recommendations for May 2016 . Recommends against approval of Takeda Pharmaceutical Co Ltd's <4502.T> ixazomib to treat multiple myeloma . Recommends approval of AstraZeneca Plc's saxagliptin/dapagliflozin to treat type 2 diabetes . Recommends approval of Takeda Pharmaceutical Co Ltd and Janssen's bortezomib to treat multiple myeloma . Recommends approval of Gilead Sciences Inc's sofosbuvir/velpatasvir to treat Hepatitis C .Recommends approval of Merck & Co's Elbasvir / grazoprevir to treat Hepatitis C.  Full Article

BRIEF-FDA approves Astrazeneca's blood-based companion diagnostic for Tagrisso (osimertinib)

* U.S. FDA has approved a blood-based companion diagnostic for Tagrisso (osimertinib) Source text for Eikon: Further company coverage: