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AstraZeneca PLC (AZN.L)

AZN.L on London Stock Exchange

26 May 2017
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Latest Key Developments (Source: Significant Developments)

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

Knight Therapeutics announces exclusive license agreement with AstraZeneca
Thursday, 15 Dec 2016 07:30am EST 

Knight Therapeutics Inc : The financial terms of agreement were not disclosed . Knight therapeutics- as per agreement, co will be responsible for all commercial, regulatory, certain supply chain activities for movantik in canada, israel . Movantik is currently under regulatory review in israel and, when approved, will be marketed under name moventig .Press release - knight therapeutics announces exclusive license agreement with astrazeneca for movantik/moventig(r) in canada and israel.  Full Article

AstraZeneca CEO: drug price pressure won't go away under Trump
Thursday, 10 Nov 2016 05:04am EST 

Astrazeneca executives comment to reporters after Q3 results: R&D executive says overall survival data from Mystic lung cancer trial expected in 2018, PFS data seen first half 2017 . CEO says U.S. price pressure won't go away with Trump presidency . CEO says hopes any replacement to Obamacare will promote innovation in medicine . CEO says confident of resuming enrolment in head and neck cancer drug trials after pause due to bleeding cases . CFO says Saudi Arabia healthcare cuts hurt Symbicort in Q3 because company no.1 in respiratory medicine in country . CEO says expects return to growth in second half of 2017, no drug patent expiries 2018-24 Further company coverage: [AZN.L] (Reporting by UK bureau) ((uk.online@reuters.com;)).  Full Article

AstraZeneca says Lynparza late-stage study succeeds
Wednesday, 26 Oct 2016 02:00am EDT 

AstraZeneca Plc : AstraZeneca plc - positive results in AstraZeneca Lynparza trial . Lynparza phase III SOLO-2 trial shows significant progression-free survival benefit . Initial findings show safety profile with Lynparza tablets was consistent with previous studies . Results from trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free survival .Median PFS in Lynparza arm of SOLO-2 substantially exceeded that observed in phase II maintenance study in patients with platinum-sensitive relapsed ovarian cancer.  Full Article

Synairgen says AstraZeneca decided to stop phase IIa AZD9412 trial
Wednesday, 12 Oct 2016 02:00am EDT 

Synairgen Plc : AZD9412 clinical trial update . Received Inexas clinical trial update from AstraZeneca relating to AZD9412 . AstraZeneca has decided to stop phase IIa trial for AZD9412 based on an interim analysis . interim analysis showed an overall very low number of reported severe exacerbations that could make primary endpoint conclusions difficult .AstraZeneca will evaluate key data collected from Inexas trial with a focus on secondary endpoints.  Full Article

Insmed announces worldwide license agreement with AstraZeneca for oral DPP1 inhibitor
Wednesday, 5 Oct 2016 06:55am EDT 

Insmed Inc : Insmed will pay AstraZeneca an upfront payment of $30 million . Agreement provides AstraZeneca with option to negotiate a future agreement with Insmed for commercialization of AZD7986/ins1007 . Continue to expect patient enrollment in phase 3 study of Arikayce to conclude later this year and to report top line data in 2017 . Confirms its cash operating expense guidance for second half of 2016 of $62 million to $72 million . In a phase 1 study of healthy volunteers AZD7986 was well tolerated . Says AstraZeneca will be eligible to receive future payments totaling $120 mln in future clinical, regulatory, and sales-related milestones .Confirms its cash operating expense guidance for second half of 2016 of $62 to $72 million..  Full Article

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BRIEF-AstraZeneca recalls one lot of Brilinta professional sample bottles

* Astrazeneca initiates voluntary nationwide recall of one lot of brilinta 90mg professional sample bottles due to report of another medicine in one bottle from that lot