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AstraZeneca PLC (AZN.L)

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Latest Key Developments (Source: Significant Developments)

AstraZeneca says U.S. FDA accepts new drug application for Lynparza
7:00am EDT 

AstraZeneca Plc : U.S. FDA has accepted company's new drug application (NDA) for Lynparza (olaparib) tablets .Granted priority review status with a prescription drug user fee act (PDUFA) set for Q3 2017.  Full Article

Astrazeneca signs deal with Circassia over Almirall's products
Friday, 17 Mar 2017 03:13am EDT 

Almirall SA : Astrazeneca enters into a strategic collaboration with Circassia for the development and commercialization of Tudorza and Duaklir in the United States [nFWN1GT0XB] . Says Tudorza, Duaklir are products licensed by Almirall to Astrazeneca in an agreement from July 30, 2014 .Under terms of collaboration, Circassia will lead promotion of Tudorza in the US and has been granted an option to gain full commercial rights in the future.  Full Article

Circassia to secure certain U.S. commercial rights to Tudorza, Duaklir from AstraZeneca
Friday, 17 Mar 2017 03:00am EDT 

Circassia Pharmaceuticals Plc : Proposed collaboration and securing of certain U.S. Commercial rights to Tudorza And Duaklir from Astrazeneca . Deal for consideration of up to us$230 million . Deal includes US$50 million in ordinary shares plus future royalties based on Duaklir sales . Intends to fund deferred and contingent consideration through third-party financing . Circassia will make research and development contributions of up to US$62.5 million payable to Astrazeneca as deferred payments . Intends to fund research and development contributions through its returns from commercial collaboration and profit share with Astrazeneca .Deal anticipated to be earnings enhancing for Circassia after one year and broadly cash neutral for three years, then cash generative.  Full Article

AstraZeneca receives FDA response to hyperkalaemia drug application
Friday, 17 Mar 2017 03:00am EDT 

Astrazeneca Plc : Receives complete response letter from US FDA for zs-9 (sodium zirconium cyclosilicate) for hyperkalaemia . Crl does not require generation of any new clinical data .Astrazeneca and ZS Pharma are committed to working with fda to resolve remaining matters under review as soon as possible.  Full Article

Sanofi Pasteur and Medimmune collaborate on monoclonal antibody to prevent illnesses associated with RSV
Friday, 3 Mar 2017 02:00am EST 

Sanofi : Sanofi Pasteur and Medimmune [MEDI.UL] collaborate on monoclonal antibody to prevent illnesses associated with RSV . Sanofi Pasteur will make an upfront payment of 120 million euros and pay up to 495 million euros upon achievement of certain development and sales-related milestones . Two companies will share all costs and profits equally . Medimmune will continue to lead all development activity up to first approval, and AstraZeneca will retain medi8897 manufacturing activities .Sanofi Pasteur will lead commercialization activities for medi8897.  Full Article

Astrazeneca says U.S. FDA approves once-daily qtern for type-2 diabetes
Tuesday, 28 Feb 2017 01:51am EST 

Astrazeneca Plc : FDA approves once-daily qtern for type-2 diabetes . Astrazeneca - qtern fixed-dose combination will provide additional oral medicine option for patients taking farxiga to improve blood sugar level (Bengaluru Newsroom: +91 80 6749 1136).  Full Article

EU regulator recommends condition approval of Shire's chronic hypoparathyroidism medicine
Friday, 24 Feb 2017 07:00am EST 

EU Medicines Agency: Recommendations for February 2017 . Recommends conditional marketing authorisation of Shire's orphan medicine Natpar for chronic hypoparathyroidism . Recommends approval of Astrazeneca's ZS-9 (sodium zirconium cyclosilicate) for high potassium levels . Recommends approval of Tesaro Inc's rolapitant, against chemotherapy-induced nausea and vomiting . Recommends approval of Gilead's Descovy for the treatment of HIV Link to press release: (http://bit.ly/2lCHPks) Further company coverage: [AZN.L][SHP.L][GILD.O][TSRO.O] (Bengaluru Newsroom: +91 806 749 1136).  Full Article

Astrazeneca says will get $130 mln as milestone payment after Brodalumab approval
Thursday, 16 Feb 2017 07:01am EST 

Astrazeneca Plc : Partner Valeant Pharmaceuticals announced that US FDA has approved Siliq (Brodalumab) injection for treatment of adult patients with moderate-to-severe plaque psoriasis . Through a collaboration agreement, astrazeneca granted valeant exclusive license to develop and commercialise siliq globally, except in japan and certain other asian countries . Under terms of agreement, Astrazeneca will receive a milestone payment of $130 million from valeant at first regulatory approval . This milestone will be recorded in Astrazeneca financial statements as externalisation revenue .Following approval, Astrazeneca and Valeant will share profits from sale of siliq in US market..  Full Article

AstraZeneca CEO says MYSTIC cancer drug trial "not binary"
Thursday, 2 Feb 2017 02:41am EST 

Astrazeneca CEO Pascal Soriot told reporters after Q4 results: Believes in strong science-led FDA . FDA has already taken steps to accelerate approvals, especially in cancer . Limit to how fast FDA can go, in response to Trump comments on faster approvals . U.S. price pressures will continue . Primary care drugs a particular focus for U.S. pricing pressure . Will adjust to U.S. price pressures as have done for long time in Europe . MYSTIC study "not binary . "Very unlikely" that neither mono or combination work in MYSTIC . CAn look at bristol filing decision on chemo-I/O combo as positive or negative for AZ . Believes UK government is very committed to creating strong life sciences industry post-Brexit . Logical to assume UK will have to have its own drugs regulator post-brexit but may have reciprocal approval agreement with EMA Further company coverage: [AZN.L] (Reporting by UK bureau) ((uk.online@reuters.com;)).  Full Article

AstraZeneca says asthma drug granted paediatric exclusivity in U.S.
Thursday, 26 Jan 2017 05:00am EST 

AstraZeneca Plc : Symbicort granted paediatric exclusivity in U.S. .Says decision was based on evaluation of trials conducted in children with asthma aged six up to 12 years in response to a written request.  Full Article

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* Astrazeneca - announced new results data evaluating cost-effectiveness of synagis for respiratory syncytial virus in preterm infants 29-34 weeks gestational age