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AstraZeneca PLC (AZN.L)

AZN.L on London Stock Exchange

23 Jun 2017
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Latest Key Developments (Source: Significant Developments)

FDA grants accelerated approval to Durvalumab for treatment of patients with locally advanced or metastatic urothelial carcinoma
Monday, 1 May 2017 01:10pm EDT 

May 1 (Reuters) - U.S. FDA :Grants accelerated approval to Durvalumab for treatment of patients with locally advanced or metastatic urothelial carcinoma.Approved Ventana PD-l1 assay as complementary diagnostic for assessment of PD-l1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue.  Full Article

GSK still in talks with AstraZeneca about start date for Luke Miels
Wednesday, 26 Apr 2017 10:26am EDT 

April 26 (Reuters) - GlaxoSmithKline Plc CEO Emma Walmsley told analysts::"no comment" on whether would launch authorised advair generic in u.s..still in discussion with AstraZeneca about date for Luke Miels to join GSK.  Full Article

AstraZeneca's lung cancer drug receives full EU approval
Tuesday, 25 Apr 2017 08:30am EDT 

April 25 (Reuters) - AstraZeneca Plc ::Tagrisso receives full approval in the EU.European Commission has granted full marketing authorisation for Tagrisso (osimertinib).Grant for treatment of adults with locally-advanced or metastatic epidermal growth factor receptor T790m mutation-positive non-small cell lung cancer.In March 2017, US Food and Drug Administration granted Tagrisso a conversion from accelerated to full approval.Warnings and precautions include interstitial lung disease (ILD), keratitis, left ventricular ejection fraction (LVEF) and QTC interval prolongation.  Full Article

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

Astrazeneca signs deal with Circassia over Almirall's products
Friday, 17 Mar 2017 03:13am EDT 

Almirall SA : Astrazeneca enters into a strategic collaboration with Circassia for the development and commercialization of Tudorza and Duaklir in the United States [nFWN1GT0XB] . Says Tudorza, Duaklir are products licensed by Almirall to Astrazeneca in an agreement from July 30, 2014 .Under terms of collaboration, Circassia will lead promotion of Tudorza in the US and has been granted an option to gain full commercial rights in the future.  Full Article

Circassia to secure certain U.S. commercial rights to Tudorza, Duaklir from AstraZeneca
Friday, 17 Mar 2017 03:00am EDT 

Circassia Pharmaceuticals Plc : Proposed collaboration and securing of certain U.S. Commercial rights to Tudorza And Duaklir from Astrazeneca . Deal for consideration of up to us$230 million . Deal includes US$50 million in ordinary shares plus future royalties based on Duaklir sales . Intends to fund deferred and contingent consideration through third-party financing . Circassia will make research and development contributions of up to US$62.5 million payable to Astrazeneca as deferred payments . Intends to fund research and development contributions through its returns from commercial collaboration and profit share with Astrazeneca .Deal anticipated to be earnings enhancing for Circassia after one year and broadly cash neutral for three years, then cash generative.  Full Article

AstraZeneca receives FDA response to hyperkalaemia drug application
Friday, 17 Mar 2017 03:00am EDT 

Astrazeneca Plc : Receives complete response letter from US FDA for zs-9 (sodium zirconium cyclosilicate) for hyperkalaemia . Crl does not require generation of any new clinical data .Astrazeneca and ZS Pharma are committed to working with fda to resolve remaining matters under review as soon as possible.  Full Article

More From Around the Web


GSK's new pharma head to join in September after AstraZeneca tussle

LONDON GlaxoSmithKline has struck a deal for Luke Miels to start as its new head of pharmaceuticals in September, following a lengthy dispute over his contract with his former employer AstraZeneca.