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AstraZeneca PLC (AZN)

AZN on New York Consolidated

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20 Oct 2017
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Latest Key Developments (Source: Significant Developments)

Roivant Sciences partners with AstraZeneca for drug development
Thursday, 19 Oct 2017 09:00am EDT 

Oct 19 (Reuters) - AstraZeneca Plc :Roivant Sciences says entered into a development partnership with AstraZeneca for a deprioritized investigational drug in an undisclosed indication​.Deal terms of partnership include an upfront payment, development milestones, and royalties.  Full Article

Fibrogen announces acceptance by china FDA of roxadustat NDA for treatment of anemia associated with dialysis and non-dialysis kidney disease
Wednesday, 18 Oct 2017 07:00am EDT 

Oct 18 (Reuters) - Fibrogen Inc :Fibrogen announces acceptance by china FDA of roxadustat new drug application (NDA) for treatment of anemia associated with dialysis and non-dialysis chronic kidney disease (CKD).Fibrogen - ‍under terms of Fibrogen's agreement with Astrazeneca, NDA submission triggers a $15 million milestone payment, payable to co by Astrazeneca​.  Full Article

Astrazeneca says US FDA accepts regulatory submission for Lynparza
Wednesday, 18 Oct 2017 02:00am EDT 

Oct 18 (Reuters) - Astrazeneca Plc ::US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review​.  Full Article

Astrazeneca says U.S. FDA accepts supplemental biologics license application for imfinzi
Tuesday, 17 Oct 2017 07:00am EDT 

Oct 17 (Reuters) - Astrazeneca Plc :U.S. FDA accepts supplemental biologics license application for imfinzi (durvalumab) in locally advanced, unresectable non-small cell lung cancer.Astrazeneca Plc - ‍imfinzi granted priority review​.  Full Article

AstraZeneca says ‍US FDA accepts supplemental biologics license application for Imfinzi
Tuesday, 17 Oct 2017 02:00am EDT 

Oct 17 (Reuters) - Astrazeneca Plc :‍US FDA ACCEPTS SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR IMFINZI IN LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER​.  Full Article

EU Medicines Agency provides recommendations for October 2017
Friday, 13 Oct 2017 08:02am EDT 

Oct 13 (Reuters) - EU MEDICINES AGENCY::EU MEDICINES AGENCY RECOMMENDATIONS FOR OCTOBER 2017‍​.EU MEDICINES AGENCY - CHMP RECOMMENDED EXTENSIONS OF INDICATIONS FOR ALECENSA, BYDUREON, CUBICIN, FASLODEX, PEGASYS AND ZYTIGA‍​.  Full Article

Circassia Pharmaceuticals says H1 revenues up 65 pct to 18.3 mln pounds
Wednesday, 27 Sep 2017 02:00am EDT 

Sept 27 (Reuters) - CIRCASSIA PHARMACEUTICALS PLC ::H1 REVENUE OF 18.3 MILLION STG VERSUS 11.1 MILLION STG YEAR AGO.H1 RESEARCH AND DEVELOPMENT EXPENDITURE OF 27.2 MILLION STG VERSUS 25.1 MILLION STG YEAR AGO.H1 NIOX SALES GROWTH 19 PERCENT (8% AT CER 3 ) TO £13.1 MILLION​.‍IN KEY US MARKET, TARGETING A SUBSTANTIALLY LARGER CUSTOMER BASE THAN AT THIS TIME LAST YEAR​.H1 GROUP LOSS BEFORE TAX OF 39.6 MILLION STG VERSUS LOSS OF 107.6 MILLION STG YEAR AGO.‍"ANTICIPATE ROBUST REVENUE GROWTH FOR BOTH NIOX AND TUDORZA"​.‍PARTNER ASTRAZENECA IS ON TRACK TO SUBMIT AN NDA FOR DUAKLIR IN FIRST HALF OF 2018​.  Full Article

NewLink Genetics announces clinical collaboration with AstraZeneca​
Monday, 25 Sep 2017 06:00am EDT 

Sept 25 (Reuters) - NewLink Genetics Corp :Newlink Genetics announces clinical collaboration to evaluate IO-based combination therapies in pancreatic cancer.NewLink Genetics Corp - ‍Phase 2 trial will be funded equally by both companies, with NewLink Genetics serving as study sponsor​.NewLink Genetics Corp - ‍announced that it has entered into a clinical collaboration agreement with AstraZeneca​.NewLink Genetics Corp - NewLink Genetics' share of aggregate expense of trial is not expected to have a material effect on its financial position​.NewLink Genetics Corp - ‍patients will also be enrolled into a smaller cohort evaluating combination of durvalumab with gemcitabine/abraxane​.  Full Article

Flexion Therapeutics says co sent a notice of termination to Astrazeneca AB regarding an out-license agreement between parties​
Thursday, 14 Sep 2017 04:48pm EDT 

Sept 15 (Reuters) - Flexion Therapeutics Inc :Flexion Therapeutics Inc - ‍on September 8, co sent a notice of termination to Astrazeneca AB regarding an out-license agreement between parties​.Flexion Therapeutics Inc - ‍out-license agreement related to co's FX005 sustained-release p38 MAP.Flexion Therapeutics Inc - ‍pursuant to terms of out-license agreement, termination will be effective three months after company's delivery of notice​.Flexion Therapeutics Inc - ‍upon termination of out-license agreement, Flexion's license rights pertaining to FX005 will revert to Astrazeneca​.Flexion Therapeutics Inc - ‍upon termination of out-license agreement Flexion's milestone, royalty and patent maintenance obligations under agreement will cease.​.  Full Article

Astrazeneca says Aspen acquires remaining rights to AZ anaesthetics
Thursday, 14 Sep 2017 02:00am EDT 

Sept 14 (Reuters) - Astrazeneca Plc ::ASPEN ACQUIRES REMAINING RIGHTS TO AZ ANAESTHETICS.ENTERED AGREEMENT WITH ASPEN GLOBAL; AGI TO ACQUIRE RESIDUAL RIGHTS TO ESTABLISHED ANAESTHETIC MEDICINES.UUNDER NEW AGREEMENT, AGI WILL NO LONGER PAY ROYALTIES TO ASTRAZENECA​.AGI TO BUY REMAINING RIGHTS TO INTELLECTUAL PROPERTY; MANUFACTURING KNOW- HOW RELATED TO ANAESTHETIC MEDICINES FOR UPFRONT CONSIDERATION OF $555 MILLION.‍NEW, ADDITIONAL AGREEMENT IS EXPECTED TO CLOSE IN Q4 OF 2017, DOES NOT IMPACT ASTRAZENECA'S FINANCIAL GUIDANCE FOR 2017​.AGI TO PAY ASTRAZENECA UP TO $211 MLN IN PERFORMANCE-RELATED MILESTONES BASED ON SALES; GROSS MARGIN DURING PERIOD FROM 1 SEPT TO 30 NOV 2019.ASTRAZENECA WILL CONTINUE TO MANUFACTURE AND SUPPLY MEDICINES TO AGI DURING A TRANSITION PERIOD OF UP TO FIVE YEARS.  Full Article

BRIEF-Roivant Sciences partners with AstraZeneca for drug development

* Roivant Sciences says entered into a development partnership with AstraZeneca for a deprioritized investigational drug in an undisclosed indication​