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AstraZeneca PLC (AZN.N)

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Latest Key Developments (Source: Significant Developments)

Aralez Pharma says co and U.S. Government entered into modification of contract
Tuesday, 11 Apr 2017 04:30pm EDT 

Aralez Pharmaceuticals Inc : Aralez Pharma - on April 6, aralez us and u.s. government entered into modification of contract under which government exercised first renewal option under deal .Aralez Pharmaceuticals Inc - U.S. Government extended term of agreement by one year to April 28, 2018 with modified pricing for duration thereof.  Full Article

Fibrogen wins China clearance to conduct key study testing roxadustat
Friday, 31 Mar 2017 07:05am EDT 

Fibrogen Inc : Fibrogen announces china fda approval of cta to conduct pivotal phase 2/3 clinical trial of roxadustat in anemia associated with lower risk mds . Fibrogen inc - fibrogen is conducting all clinical trials and regulatory submissions in both u.s. And china . Fibrogen inc - company expects to initiate this phase 2/3 study in second half of 2017 . In addition, company anticipates initiating a u.s. Phase 3 mds clinical trial in q3 of 2017 .Fibrogen inc - fibrogen will retain all regulatory licenses and manufacturing permits in china for roxadustat in anemia associated with lower risk mds.  Full Article

Impax announces favorable ruling regarding patent validity for Zomig Nasal Spray
Thursday, 30 Mar 2017 04:52pm EDT 

Impax Laboratories Inc : Impax announces favorable ruling regarding patent validity for Zomig (zolmitriptan) Nasal Spray .Impax Laboratories - judge found U.S. patents protecting zomig Nasal Spray not invalid and are infringed by Lannett Holdings Inc and Lannett Co ANDA.  Full Article

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

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Analysis -As AstraZeneca chases rivals, immuno-oncology gets complicated

LONDON Three years after Pfizer's failed bid for AstraZeneca, the British drugmaker aims to prove in the coming weeks that its cancer immunotherapy can deliver on bold sales forecasts made during that takeover battle.