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AstraZeneca PLC (AZN)

AZN on New York Consolidated

30 Mar 2017
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$-0.11 (-0.35%)
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Latest Key Developments (Source: Significant Developments)

AstraZeneca says U.S. FDA accepts new drug application for Lynparza
Tuesday, 28 Mar 2017 07:00am 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

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

GlaxoSmithKline appoints Luke Miels President, Global Pharma
Thursday, 19 Jan 2017 02:09am EST 

Glaxosmithkline Plc : Luke Miels appointed president, global pharmaceuticals, gsk .Luke is currently executive vice president (evp) of astrazeneca's european business.  Full Article

Pfizer completes acquisition of small molecule anti-infective business from AstraZeneca
Friday, 23 Dec 2016 02:05am EST 

Pfizer Inc : Says completed acquisition of development rights to Astrazeneca's late-stage anti-infective business, primarily outside united states .Pfizer completes acquisition of small molecule anti-infective business from Astrazeneca.  Full Article

AstraZeneca completes sale of antibiotics business to Pfizer
Friday, 23 Dec 2016 02:00am EST 

AstraZeneca Plc : AZ completes sale of antibiotics business . Has completed agreement with Pfizer Inc for sale of commercialisation and development rights to its late-stage small molecule antibiotics business . AstraZeneca has received a payment of $550 million for commercialisation and development rights to late-stage antibiotics business in all markets where AstraZeneca holds rights . Pfizer will pay a further $175 mln in January 2019, up to $250 mln in commercial, manufacturing and regulatory milestones . Pfizer will pay up to $600 mln in sales-related payments as well as recurring, double-digit royalties .$550 mln upfront and $175 mln unconditional payment will both be booked in Q4 of 2016, net of a product intangible.  Full Article

More From Around the Web

BRIEF-AstraZeneca's autoimmune disease drug receives orphan designation

* Potential medicine for neuromyelitis optica spectrum disorder receives orphan designation in europe Source text for Eikon: Further company coverage: (Reporting By London Bureau)