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AstraZeneca PLC (AZN.L)

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Latest Key Developments (Source: Significant Developments)

Trovagene enters into agreement with Astrazeneca to utilize Trovera CTDNA test and services in prospective biomarker study
Monday, 12 Jun 2017 08:00am EDT 

June 12 (Reuters) - Trovagene Inc :Trovagene enters into agreement with astrazeneca to utilize trovera® ctdna test and services in prospective biomarker study.Trovagene Inc - has entered into an agreement with astrazeneca to provide trovera® urine ctdna biomarker test and services.Trovagene Inc - trovera egfr urine liquid biopsy test will initially be used in an open label prospective biomarker study.  Full Article

Regulus says plans to discontinue clinical development of RG-101
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Regulus Therapeutics Inc :Regulus announces pipeline updates and advancements.Regulus -plans to discontinue clinical development of rg-101 upon completion of one remaining clinical study, which is expected to occur in july 2017.Regulus therapeutics inc says initiation of phase ii clinical programs for rg-012 for treatment of alport syndrome is on track as planned.Regulus therapeutics inc says data from renal biopsy study is anticipated by year-end and interim data from hera is anticipated mid-2018.Regulus -evaluation of clinical data led to identification of a bilirubin transport mechanism as likely cause for cases of hyperbilirubinemia in rg-101 program.Regulus therapeutics inc says ind for rgls4326 is on track for filing by year end 2017.Regulus - astrazeneca informed co that it intends to terminate clinical development program for azd4076 for treatment of nash in type 2 diabetes/pre-diabetes.Regulus -under agreement, astrazeneca's rights with respect to azd4076(rg-125) will revert to regulus when termination becomes effective in twelve months.  Full Article

Astrazeneca enters agreement for Zomig rights outside Japan​
Wednesday, 7 Jun 2017 02:13am EDT 

June 7 (Reuters) - Astrazeneca Plc ::Announced that it has entered an agreement with Grünenthal for global rights to Zomig (Zolmitriptan) outside Japan​.Grünenthal to pay Astrazeneca $200 million upon completion. Astrazeneca to receive up to additional $102 million in future milestone payments​.Grünenthal will acquire rights to Zomig in all markets outside Japan, including us, where rights were previously licensed to Impax Pharmaceuticals​.Agreement does not impact company's financial guidance for 2017​.Impax will continue to market Zomig in US. Astrazeneca will continue to manufacture and supply medicine to Grünenthal during a transition period​.Transaction is expected to complete in Q2 of 2017, subject to customary closing conditions and regulatory clearances​.  Full Article

Eleven Biotherapeutics to collaborate with Astrazeneca, National Cancer Institute
Tuesday, 6 Jun 2017 08:00am EDT 

June 6 (Reuters) - Eleven Biotherapeutics Inc ::Eleven Biotherapeutics to collaborate with Astrazeneca and National Cancer Institute on development of vicinium in combination with durvalumab.Eleven Biotherapeutics Inc says vicinium is currently in a phase 3 registration trial for treatment of high-grade NMIBC.Eleven Biotherapeutics - for phase 3 expects to complete patient enrollment in second half of 2017, and to report topline 3-month data in Q2 of 2018.Says the combination drug is for treatment of non-muscle invasive bladder cancer.  Full Article

AstraZeneca recalls one lot of Brilinta professional sample bottles
Thursday, 25 May 2017 05:30pm EDT 

May 25 (Reuters) - AstraZeneca Plc :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.Astrazeneca - other forms or dosage strengths of brilinta, including medicine obtained via us retail or mail order pharmacies, are not affected by recall.Astrazeneca plc - ‍voluntary recall limited to lot # jb5047 of brilinta(®) (ticagrelor) 90mg tablets, 8-count professional (physician) sample bottles​.Astrazeneca - other forms or dosage strengths of brilinta, including medicine obtained via us retail or mail order pharmacies, not affected by voluntary recall.  Full Article

Recordati acquires from AstraZeneca European rights to Metoprolol based products
Monday, 22 May 2017 02:13am EDT 

May 22 (Reuters) - RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA ::ACQUIRES FROM ASTRAZENECA <<>> EUROPEAN RIGHTS TO PRODUCTS BASED ON METOPROLOL.THE CONSIDERATION FOR THE ACQUISITION OF THE ASSETS IS OF $ 300 MILLION (APPROX. € 270 MILLION) AND WILL BE FUNDED BY EXISTING LIQUIDITY AND AVAILABLE CREDIT LINES.ROYALTIES FOR THE USE OF THE EXISTING PRODUCT BRANDS WILL BE DUE TO ASTRAZENECA FOR AN AGREED PERIOD.METOPROLOL SUCCINATE IS A BETA‐BLOCKER FOR THE CONTROL OF HYPERTENSION, ANGINA AND HEART FAILURE.EXISTING SALES OF THE METOPROLOL BRANDS WILL PROVIDE THE BASE TO ENTER NEW MARKETS AND COMPLETE EUROPEAN GEOGRAPHICAL FOOTPRINT.  Full Article

AstraZeneca says Leo Pharma has received positive opinion from CHMP of EMA recommending approval of Brodalumab
Friday, 19 May 2017 12:32pm EDT 

May 19 (Reuters) - AstraZeneca Plc ::Brodalumab receives positive chmp opinion for treatment of adult patients with moderate-to-severe plaque psoriasis.co's partner Leo Pharma has received positive opinion from CHMP of EMA recommending approval of Brodalumab.  Full Article

Inovio pharmaceuticals says AstraZeneca's MedImmune will start new clinical trial
Wednesday, 10 May 2017 08:00am EDT 

May 10 (Reuters) - Inovio Pharmaceuticals Inc :Inovio provides update on MedImmune launch of combination trial for hpv-associated head & neck cancer.Inovio Pharmaceuticals-AstrazZneca's medimmune will start a new clinical trial investigating combination of medi0457.Inovio Pharmaceuticals-new clinical trial will investigate combination of medi0457 and durvalumab, an investigational pd-l1 checkpoint inhibitor.  Full Article

Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in Urothelial Carcinoma
Tuesday, 2 May 2017 03:36pm EDT 

May 2 (Reuters) - Roche Holding Ag : :Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in Urothelial Carcinoma.Continues to pursue regulatory approval for Ventana PD-L1 (SP263) assay in other cancer indications in US and in other geographies.  Full Article

AstraZeneca's durvalumab average monthly cost around $15,000
Monday, 1 May 2017 02:56pm EDT 

May 1 (Reuters) - AstraZeneca :Says average wholesale acquisition cost of durvalumab around $15,000/month, following FDA approval of drug for bladder cancer.  Full Article

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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.