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AstraZeneca PLC (AZN.L)

AZN.L on London Stock Exchange

5,606.00GBp
18 Jul 2018
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55.00 (+0.99%)
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Latest Key Developments (Source: Significant Developments)

Astrazeneca Says EU Approves Tagrisso For 1st-line Treatment Of EGFR-mutated Non-Small Cell Lung Cancer
Friday, 8 Jun 2018 12:30pm EDT 

June 8 (Reuters) - AstraZeneca PLC ::EU APPROVES TAGRISSO FOR 1ST-LINE TREATMENT OF EGFR-MUTATED NON-SMALL CELL LUNG CANCER.APPROVAL IS BASED ON RESULTS FROM PHASE III FLAURA TRIAL PUBLISHED IN NEW ENGLAND JOURNAL OF MEDICINE.APPROVAL FOLLOWS POSITIVE OPINION FROM COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OF EUROPEAN MEDICINES AGENCY.  Full Article

Almirall: Astrazeneca Submitts NDA To The US FDA For Duaklir
Friday, 1 Jun 2018 02:02am EDT 

June 1 (Reuters) - Almirall SA ::NEW DRUG APPLICATION (NDA) SUBMISSION TO THE US FDA FOR DUAKLIR.NDA SUBMISSION IS BASED ON THE POSITIVE RESULTS OF THE AMPLIFY STUDY.PARTNER ASTRAZENECA SUBMITTING NEW DRUG APPLICATION FOR DUAKLIR MAY TRIGGER ADDITIONAL MILESTONES TO ALMIRALL.  Full Article

AstraZeneca CEO Says Drug Industry Needs Clarity On Regulation After Brexit
Friday, 18 May 2018 04:46am EDT 

May 18 (Reuters) - AstraZeneca PLC Pascal Soriot tells reporters::CEO SAYS STILL DON'T KNOW WHETHER WILL BE MUTUAL RECOGNITION FOR DRUG REGULATION AFTER BREXIT AND INDUSTRY NEEDS CLARITY.  Full Article

AstraZeneca CEO Says More Drug Industry Consolidation Possible
Friday, 18 May 2018 04:32am EDT 

May 18 (Reuters) - AstraZeneca PLC CEO Pascal Soriot tells reporters::CEO SAYS MORE CONSOLIDATION IN DRUG INDUSTRY POSSIBLE.CEO SAYS AZ HAS GLOBAL SCALE, FOCUSED ON NEW DRUG LAUNCHES.  Full Article

G1 Therapeutics Announces Initiation Of Phase 1B/2 Clinical Trial Of G1T38 In Combination With Tagrisso
Monday, 16 Apr 2018 06:00am EDT 

April 16 (Reuters) - G1 Therapeutics Inc ::G1 THERAPEUTICS ANNOUNCES INITIATION OF PHASE 1B/2 CLINICAL TRIAL OF G1T38 IN COMBINATION WITH TAGRISSO FOR EGFR-MUTANT NON-SMALL CELL LUNG CANCER.G1 THERAPEUTICS INC - ASTRAZENECA IS PROVIDING TAGRISSO FOR PHASE 1B/2 CLINICAL TRIAL UNDER NON-EXCLUSIVE CLINICAL TRIAL COLLABORATION AGREEMENT.G1 THERAPEUTICS - OPEN-LABEL TRIAL IS EXPECTED TO ENROLL APPROXIMATELY 145 PARTICIPANTS IN TWO PARTS.  Full Article

AstraZeneca Says US FDA Approves BYDUREON For Use With Basal Insulin In Patients With Type 2 Diabetes With Inadequate Glycemic Control
Tuesday, 3 Apr 2018 08:00am EDT 

April 3 (Reuters) - AstraZeneca PLC ::US FDA APPROVES BYDUREON FOR USE WITH BASAL INSULIN IN PATIENTS WITH TYPE 2 DIABETES WITH INADEQUATE GLYCEMIC CONTROL.7 STUDY RESULTS SHOWED SIGNIFICANT HBA1C REDUCTION WHEN BYDUREON WAS ADDED TO INSULIN GLARGINE THERAPY VERSUS INSULIN GLARGINE ALONE​.  Full Article

FDA Accepts Biologics License Application For Moxetumomab Pasudotox
Tuesday, 3 Apr 2018 07:00am EDT 

April 3 (Reuters) - AstraZeneca PLC ::US FDA ACCEPTS BIOLOGICS LICENSE APPLICATION FOR MOXETUMOMAB PASUDOTOX IN HAIRY CELL LEUKEMIA.FDA GRANTED MOXETUMOMAB PASUDOTOX BLA PRIORITY REVIEW STATUS WITH A PRESCRIPTION DRUG USER FEE ACT DATE SET FOR Q3 OF 2018.  Full Article

Astrazeneca Says ‍U.S. FDA Accepts BLA For Moxetumomab Pasudotox In Hairy Cell Leukaemia​
Tuesday, 3 Apr 2018 02:01am EDT 

April 3 (Reuters) - Astrazeneca Plc ::‍US FDA ACCEPTS BIOLOGICS LICENSE APPLICATION FOR MOXETUMOMAB PASUDOTOX IN HAIRY CELL LEUKAEMIA​.‍PHASE III MOXETUMOMAB PASUDOTOX CLINICAL TRIAL MET ITS PRIMARY ENDPOINT​.  Full Article

Astrazeneca Says European Medicines Agency Accepts Regulatory Submission For Lynparza In Brca-Mutated, Her2 Negative Metastatic
Tuesday, 3 Apr 2018 02:01am EDT 

April 3 (Reuters) - AstraZeneca PLC ::EUROPEAN MEDICINES AGENCY ACCEPTS REGULATORY SUBMISSION FOR LYNPARZA IN BRCA-MUTATED, HER2-NEGATIVE METASTATIC.CO AND MERCK ANNOUNCES EUROPEAN MEDICINES AGENCY HAS VALIDATED FOR REVIEW MARKETING AUTHORISATION APPLICATION FOR LYNPARZA (OLAPARIB).  Full Article

Myriad Receives Pre Market Approval For Its Bracanalysis Diagnostic System In Japan
Monday, 2 Apr 2018 07:05am EDT 

April 2 (Reuters) - Myriad Genetics Inc - ‍Astrazeneca And Merck Are Seeking Approval Of Lynparza In Japan For Treating Patients With Brca ::MARKET APPROVAL FOR ITS BRACANALYSIS® DIAGNOSTIC SYSTEM IN JAPAN.MUTATED METASTATIC BREAST CANCER​.  Full Article

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AstraZeneca to stockpile drugs as Brexit 'safety net'

LONDON AstraZeneca is increasing stockpiles of those medicines in Britain and Europe that could be affected by Brexit by around 20 percent, in preparation for potential disruption if the UK crashes out of the EU without a deal.