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AstraZeneca PLC (AZN.L)

AZN.L on London Stock Exchange

9 Dec 2016
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Latest Key Developments (Source: Significant Developments)

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

AstraZeneca announces positive results in breast cancer trial
Friday, 27 May 2016 02:03am EDT 

AstraZeneca Plc : Announced positive results from phase III falcon trial comparing faslodex 500mg (fulvestrant) to arimidex 1mg . Faslodex 500mg demonstrated superiority compared with arimidex 1mg in falcon; met primary endpoint of extended progression-free survival. . Full evaluation of data is ongoing and results are expected to be presented at a medical meeting in 2016. .Positive results from astrazeneca faslodex trial.  Full Article

AstraZeneca receives complete response letter from U.S. FDA for sodium zirconium cyclosilicate
Friday, 27 May 2016 02:00am EDT 

Astrazeneca Plc : Astrazeneca receives complete response letter from us fda for sodium zirconium cyclosilicate (zs-9) for oral suspension for treatment of hyperkalaemia . Co and zs pharma are evaluating content of CRL and will work closely with FDA to determine appropriate next steps for NDA . CRL refers to observations arising from a pre-approval manufacturing inspection . CRL does not require generation of new clinical data. . FDA also acknowledged receipt of recently-submitted data which it has yet to review .Interactions are ongoing with other health authorities in European Union and Australia, where sodium zirconium cyclosilicate is currently under separate regulatory review.  Full Article

AstraZeneca says launches and prices 2.2 bln euro of bonds
Monday, 9 May 2016 12:35pm EDT 

Astrazeneca Plc : Launch and pricing of eur2.2bn bond issues . Successful pricing of euro medium term notes in an aggregate principal amount of eur 2.2 billion consisting of three tranches .Proceeds of issues will be used for general corporate purposes, which may include repayment of debt.  Full Article

AstraZeneca acquires rights to Orexo OX-CLI project
Thursday, 17 Mar 2016 03:00am EDT 

Orexo AB:Says AstraZeneca acquires all rights to Orexo's OX-CLI project.Says i‍n accordance to option agreement from 2013, Orexo will receive a payment of $5 million for rights to OX-CLI.Says ‍future milestone payments can be expected when OX-CLI meets defined development and commercial objectives.Says ‍in addition to milestones Orexo will receive a tiered single digit royalty on future net-revenue​​.  Full Article

AstraZeneca says FDA approves new indication for FASLODEX
Wednesday, 2 Mar 2016 06:57pm EST 

AstraZeneca:FDA approves new indication for FASLODEX (fulvestrant).US FDA approved a new indication expanding the use of FASLODEX to include use in combination with palbociclib.  Full Article


AstraZeneca's immunotherapy enters U.S. approval process

FRANKFURT AstraZeneca's immunotherapy drug durvalumab, the British drugmaker's most important pipeline medicine, has been accepted for review by U.S. regulators against bladder cancer, potentially its first use.