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AstraZeneca PLC (AZN)

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idpickering
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Re: AstraZeneca PLC (AZN)

#239074

Postby idpickering » July 25th, 2019, 7:24 am


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Re: AstraZeneca PLC (AZN)

#241735

Postby idpickering » August 5th, 2019, 7:04 am

Forxiga label updated in the EU in type-2 diabetes

AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.


https://www.investegate.co.uk/astrazene ... 00068660H/

idpickering
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Re: AstraZeneca PLC (AZN)

#242904

Postby idpickering » August 9th, 2019, 7:07 am

Tagrisso significantly improves overall survival

Tagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer

Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous
system metastases lived without disease progression

https://www.investegate.co.uk/astrazene ... 00045270I/

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Re: AstraZeneca PLC (AZN)

#244168

Postby feinmann » August 14th, 2019, 9:45 am


idpickering
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Re: AstraZeneca PLC (AZN)

#245637

Postby idpickering » August 20th, 2019, 7:06 am

Farxiga met primary endpoint in landmark Phase III

AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo. The trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment, including those with and without type-2 diabetes


https://www.investegate.co.uk/astrazene ... 00115994J/

idpickering
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Re: AstraZeneca PLC (AZN)

#245913

Postby idpickering » August 21st, 2019, 7:04 am

Update on the Phase III NEPTUNE trial

AstraZeneca today announced final overall survival (OS) results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients. The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumour mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumour, and tumours with high levels of TMB may be more visible to the immune system.1,2


https://www.investegate.co.uk/astrazene ... 00027014J/

daveh
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Re: AstraZeneca PLC (AZN)

#246001

Postby daveh » August 21st, 2019, 12:33 pm

And the OS was not improved by the new treatment versus SoC. They say they will now look in detail at the data and see if there were any sub groups that showed improvements with the new treatment.

idpickering
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Re: AstraZeneca PLC (AZN)

#247400

Postby idpickering » August 28th, 2019, 7:09 am

Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis; https://www.investegate.co.uk/astrazene ... 05013730K/

Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease; https://www.investegate.co.uk/astrazene ... 00043734K/

Ian.

idpickering
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Re: AstraZeneca PLC (AZN)

#247661

Postby idpickering » August 29th, 2019, 7:05 am

Anifrolumab Phase III trial meets primary endpoint; https://www.investegate.co.uk/astrazene ... 00075254K/

idpickering
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Re: AstraZeneca PLC (AZN)

#248596

Postby idpickering » September 2nd, 2019, 7:09 am

Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. https://www.investegate.co.uk/astrazene ... 00078027K/

77ss
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Re: AstraZeneca PLC (AZN)

#248785

Postby 77ss » September 2nd, 2019, 8:56 pm

idpickering wrote:Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. https://www.investegate.co.uk/astrazene ... 00078027K/



AZN powers on. A big slice of luck here, by all accounts:

Due to heart complications caused by diabetes drugs in the past, regulators forced the drugmaker to conduct a cardiovascular safety study to ensure that Farxiga--which forces the kidney to remove glucose from the blood to and expel it in urine--wasn't dangerous. The trial revealed that not only was Farxiga harmless, it actually improved heart function.


https://www.marketwatch.com/story/astra ... siteid=rss

Dod101
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Re: AstraZeneca PLC (AZN)

#248790

Postby Dod101 » September 2nd, 2019, 9:47 pm

77ss wrote:
idpickering wrote:Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. https://www.investegate.co.uk/astrazene ... 00078027K/



AZN powers on. A big slice of luck here, by all accounts:

Due to heart complications caused by diabetes drugs in the past, regulators forced the drugmaker to conduct a cardiovascular safety study to ensure that Farxiga--which forces the kidney to remove glucose from the blood to and expel it in urine--wasn't dangerous. The trial revealed that not only was Farxiga harmless, it actually improved heart function.


https://www.marketwatch.com/story/astra ... siteid=rss


Hooray! Now over £75 per share.

Dod

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Re: AstraZeneca PLC (AZN)

#249649

Postby grimer » September 5th, 2019, 4:48 pm

Dod101 wrote:
77ss wrote:
idpickering wrote:Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. https://www.investegate.co.uk/astrazene ... 00078027K/



AZN powers on. A big slice of luck here, by all accounts:

Due to heart complications caused by diabetes drugs in the past, regulators forced the drugmaker to conduct a cardiovascular safety study to ensure that Farxiga--which forces the kidney to remove glucose from the blood to and expel it in urine--wasn't dangerous. The trial revealed that not only was Farxiga harmless, it actually improved heart function.


https://www.marketwatch.com/story/astra ... siteid=rss


Hooray! Now over £75 per share.

Dod


My stop loss kicked in today at 7299p.

idpickering
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Re: AstraZeneca PLC (AZN)

#249657

Postby idpickering » September 5th, 2019, 5:04 pm

grimer wrote:
My stop loss kicked in today at 7299p.


My first purchase of AZN shares was on 17 Nov 2009, buying at 2732p ps. My average purchase price since then, having topped up and top sliced periodically, but no more, is 4468p ps. I intend holding on to my shares going forward.

Ian.

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Re: AstraZeneca PLC (AZN)

#249705

Postby grimer » September 5th, 2019, 7:27 pm

idpickering wrote:
grimer wrote:
My stop loss kicked in today at 7299p.


My first purchase of AZN shares was on 17 Nov 2009, buying at 2732p ps. My average purchase price since then, having topped up and top sliced periodically, but no more, is 4468p ps. I intend holding on to my shares going forward.

Ian.


I may buy back in if I see an opportunity. They seem a bit pricey, given the dividend cover, etc.

ADrunkenMarcus
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Re: AstraZeneca PLC (AZN)

#249777

Postby ADrunkenMarcus » September 6th, 2019, 8:07 am

A happy holder with a book cost of 1914p. AZN is 6.7% of my folio now.

I did trim in April, but the proceeds went into Mastercard.

Best wishes

Mark.

idpickering
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Re: AstraZeneca PLC (AZN)

#253192

Postby idpickering » September 23rd, 2019, 7:06 am

Qtrilmet recommended for approval in EU by CHMP

AstraZeneca today announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D).


https://www.investegate.co.uk/astrazene ... 00112444N/

daveh
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Re: AstraZeneca PLC (AZN)

#255071

Postby daveh » October 1st, 2019, 8:53 am

Divestment of omeprazole (proton pump inhibitor for GRD, ulcers and the like):
www.investegate.co.uk/article.aspx?id=2 ... 2876O&fe=1

Financial considerations
Cheplapharm will pay AstraZeneca approximately $243 million on completion of the agreement, plus sales-contingent milestones of up to $33 million in 2021 and 2022. Income arising from the upfront payment will be reported in the Company's financial statements in 2019 as Other Operating Income. In 2018, Losec sales in the countries covered by this agreement were $98 million, the majority of which were in Emerging Markets. The agreement does not change the Company's financial guidance for 2019. As there were no closing considerations to the transaction, the agreement became effective upon signing.



Update on PT010 in COPD:
www.investegate.co.uk/article.aspx?id=2 ... 2872O&fe=1

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).



Which I think means the FDA have turned down the new drug application for PT010 and given their reasons why and what AZN need to do now.

idpickering
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Re: AstraZeneca PLC (AZN)

#255769

Postby idpickering » October 4th, 2019, 7:14 am

Fasenra approved in the US for self-administration

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen).

The approval is supported by data from the Phase III GRECO trial and the Phase I AMES trial. The safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine.

https://www.investegate.co.uk/astrazene ... 00047455O/

idpickering
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Re: AstraZeneca PLC (AZN)

#259209

Postby idpickering » October 21st, 2019, 7:08 am

Farxiga approved in the US to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.


https://www.investegate.co.uk/astrazene ... 00075063Q/


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