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AstraZeneca PLC (AZN)

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idpickering
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Re: AstraZeneca PLC (AZN)

#377327

Postby idpickering » January 15th, 2021, 7:09 am

Imfinzi new dosing approved in EU

AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

Lung cancer is the leading cause of cancer death and 80-85% of patients with lung cancer have NSCLC.1-3 Approximately one third of patients are diagnosed in the Stage III setting and the majority of these have unresectable tumours and are treated with curative intent.3-5


https://www.investegate.co.uk/astrazene ... 00058327L/

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Re: AstraZeneca PLC (AZN)

#378215

Postby idpickering » January 18th, 2021, 7:10 am

Enhertu approved in the US for gastric cancer

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.


https://www.investegate.co.uk/astrazene ... 00079823L/

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Re: AstraZeneca PLC (AZN)

#380456

Postby idpickering » January 25th, 2021, 7:06 am

Calquence met primary endpoint against ibrutinib

Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca's Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib.


https://www.investegate.co.uk/astrazene ... 00077284M/

idpickering
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Re: AstraZeneca PLC (AZN)

#380462

Postby idpickering » January 25th, 2021, 7:31 am

Calquence approved in Japan for CLL

AstraZeneca's Calquence (acalabrutinib), a next-generation, selective Bruton's tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]).


https://www.investegate.co.uk/astrazene ... 05067285M/

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Re: AstraZeneca PLC (AZN)

#380781

Postby idpickering » January 26th, 2021, 7:17 am

Symbicort approved in China for mild asthma

AstraZeneca's Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) has been approved in China as an anti-inflammatory reliever to be taken as-needed in response to symptoms to achieve asthma control in patients with mild asthma aged 12 years and older.


https://www.investegate.co.uk/astrazene ... 00048851M/

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Re: AstraZeneca PLC (AZN)

#381979

Postby idpickering » January 29th, 2021, 3:46 pm

COVID-19 vaccine receives positive opinion in EU

AstraZeneca's COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford. Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks.

The CHMP recommends two doses of COVID-19 Vaccine AstraZeneca, formerly AZD1222, to be administered at a four- to 12-week interval in people aged 18 years and older. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.

AstraZeneca anticipates the EU will shortly approve a CMA for active immunisation to begin across member states.

Pascal Soriot, Chief Executive Officer, said: "Today's recommendation underscores the value of AstraZeneca's COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations. We are deeply grateful to Oxford University, participants in the clinical trials and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans."



Full item here;

https://www.investegate.co.uk/astrazene ... 16394207N/

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Re: AstraZeneca PLC (AZN)

#382026

Postby Bouleversee » January 29th, 2021, 5:39 pm

"with no severe cases and no hospitalisations more than 14 days after the second dose." What about within 12 weeks after the first dose, I wonder?

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Re: AstraZeneca PLC (AZN)

#382042

Postby dealtn » January 29th, 2021, 6:10 pm

Bouleversee wrote:"with no severe cases and no hospitalisations more than 14 days after the second dose." What about within 12 weeks after the first dose, I wonder?


I don't think you have to wonder. I believe it can be found in the COV001 trial data to get the answer (posted on this site a number of times).

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Re: AstraZeneca PLC (AZN)

#382623

Postby idpickering » February 1st, 2021, 6:28 am

AstraZeneca Boosts Dose Deliveries Amid Chaotic EU Rollout

https://www.msn.com/en-us/news/world/as ... gmoB?pfr=1

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Re: AstraZeneca PLC (AZN)

#382629

Postby idpickering » February 1st, 2021, 7:14 am

COVID-19 vaccine authorised for use by the EU

AstraZeneca's COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford. Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks.

The CHMP recommends two doses of COVID-19 Vaccine AstraZeneca, formerly AZD1222, to be administered at a four- to 12-week interval in people aged 18 years and older. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.

AstraZeneca is working with the EU following the approval of a CMA for active immunisation to begin across member states.


https://www.investegate.co.uk/astrazene ... 00095065N/

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Re: AstraZeneca PLC (AZN)

#383796

Postby idpickering » February 5th, 2021, 7:15 am

Update on KESTREL Phase III trial for Imfinzi

The KESTREL Phase III trial for AstraZeneca's Imfinzi (durvalumab) did not meet the primary endpoint of improving overall survival (OS) versus the EXTREME treatment regimen (chemotherapy plus cetuximab), a standard of care, in the 1st-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumours expressed high levels of PD-L1. Also, the combination of Imfinzi plus tremelimumab did not indicate an OS benefit in 'all-comer' patients, a secondary endpoint.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Metastatic head and neck cancer is a complex and challenging disease with a poor prognosis. While we are disappointed by these results, insights from the KESTREL Phase III trial will advance our understanding and application of immunotherapy across our clinical development programme. We will continue to build on the established benefits of Imfinzi in early lung cancer and small cell lung cancer, to bring immunotherapy treatment options to all patients who may benefit."

The safety and tolerability profiles for Imfinzi as a monotherapy and in combination with tremelimumab were consistent with previous trials. The data will be shared in due course.


https://www.investegate.co.uk/astrazene ... 00021314O/

idpickering
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Re: AstraZeneca PLC (AZN)

#385301

Postby idpickering » February 10th, 2021, 7:25 am

Divestment of Crestor in Europe completed

AstraZeneca has completed the divestment of the rights to Crestor ( rosuvastatin) and associated medicines in over 30 countries in Europe to Grünenthal GmbH (Grünenthal). Rights in the UK and Spain were not included in the agreement.

Financial considerations

Under the terms of the agreement, AstraZeneca received a payment of $320m from Grünenthal and may also be eligible for future milestone payments of up to $30m. The upfront payment will be reported in AstraZeneca's financial statements within other operating income and expense in the first quarter of 2021.


https://www.investegate.co.uk/astrazene ... 00045862O/

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Re: AstraZeneca PLC (AZN)

#385447

Postby idpickering » February 10th, 2021, 3:50 pm

Oxford-AstraZeneca Vaccine Recommended for All Adults by WHO Panel

A World Health Organization panel recommended AstraZeneca Plc’s Covid-19 vaccine for emergency use, paving the way to speed up inoculations in developing countries.

The panel recommended the vaccine for adults over 18 years old, according to a statement Wednesday. It’s set to become the second shot the WHO approves after clearing the vaccine from Pfizer Inc. and BioNTech SE in December.

It’s good news for developing countries, many of which are waiting to administer their first shots as wealthier countries have already inoculated millions of residents. AstraZeneca has pledged significant supplies to Covax, a facility that aims to distribute vaccines equitably around the world. Its shot is easier to deploy than other vaccines like Pfizer’s that need to be storesd at ultra-cold temperatures, and costs less.


https://www.msn.com/en-us/money/compani ... r-BB1dzn74

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Re: AstraZeneca PLC (AZN)

#385556

Postby idpickering » February 11th, 2021, 7:18 am


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Re: AstraZeneca PLC (AZN)

#385562

Postby Dod101 » February 11th, 2021, 8:35 am

Thanks Ian. Amongst a lot of stuff, most of which means nothing to me, they claim a progressive dividend policy which consists of a 'stable' dividend, ie another year of a held dividend.

I honestly find it difficult to see where this company is going, a bit like its stablemate, Glaxo. 'Stable' is the new woprd.

Dod

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Re: AstraZeneca PLC (AZN)

#385565

Postby scrumpyjack » February 11th, 2021, 8:46 am

The dividend is lower in GBP, 137.4p vs 146.4p obviously as the pound has risen.
xd 25/2, pay 29/3

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Re: AstraZeneca PLC (AZN)

#385570

Postby Dod101 » February 11th, 2021, 9:04 am

Thanks SJ, I had not picked up on that. We cannot blame Astra for the exchange rate!

Dod

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Re: AstraZeneca PLC (AZN)

#385578

Postby 77ss » February 11th, 2021, 9:17 am

Dod101 wrote:Thanks Ian. Amongst a lot of stuff, most of which means nothing to me, they claim a progressive dividend policy which consists of a 'stable' dividend, ie another year of a held dividend.

I honestly find it difficult to see where this company is going, a bit like its stablemate, Glaxo. 'Stable' is the new woprd.

Dod


Tear your eyes away from the dividend and look at the growth areas.

Oncology sales, for example, have practically tripled in the past 3 years. From $4bn to $11.5bn. I find this encouraging.

Over the same time period, the share price has increased by nearly 41%. I certainly don't worry about a held dividend.

I agree that they are bending the language - which I find irritating, but I look beyond that.

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Re: AstraZeneca PLC (AZN)

#385582

Postby Dod101 » February 11th, 2021, 9:23 am

77ss wrote:
Dod101 wrote:Thanks Ian. Amongst a lot of stuff, most of which means nothing to me, they claim a progressive dividend policy which consists of a 'stable' dividend, ie another year of a held dividend.

I honestly find it difficult to see where this company is going, a bit like its stablemate, Glaxo. 'Stable' is the new woprd.

Dod


Tear your eyes away from the dividend and look at the growth areas.

Oncology sales, for example, have practically tripled in the past 3 years. From $4bn to $11.5bn. I find this encouraging.

Over the same time period, the share price has increased by nearly 41%. I certainly don't worry about a held dividend.

I agree that they are bending the language - which I find irritating, but I look beyond that.


You are right of course, but the benefits always seem to be round the next corner. This is not supposed to be merely a research institute.

Dood

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Re: AstraZeneca PLC (AZN)

#385584

Postby dealtn » February 11th, 2021, 9:26 am

Dod101 wrote:
77ss wrote:
Dod101 wrote:Thanks Ian. Amongst a lot of stuff, most of which means nothing to me, they claim a progressive dividend policy which consists of a 'stable' dividend, ie another year of a held dividend.

I honestly find it difficult to see where this company is going, a bit like its stablemate, Glaxo. 'Stable' is the new woprd.

Dod


Tear your eyes away from the dividend and look at the growth areas.

Oncology sales, for example, have practically tripled in the past 3 years. From $4bn to $11.5bn. I find this encouraging.

Over the same time period, the share price has increased by nearly 41%. I certainly don't worry about a held dividend.

I agree that they are bending the language - which I find irritating, but I look beyond that.


You are right of course, but the benefits always seem to be round the next corner. This is not supposed to be merely a research institute.

Dood


Not sure what you mean by benefits. Isn't a $7.5bn increase in sales a benefit?


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