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AstraZeneca PLC (AZN)

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Dod101
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Re: AstraZeneca PLC (AZN)

#385590

Postby Dod101 » February 11th, 2021, 9:47 am

I agree that a closer look at their numbers is quite encouraging. I will leave it there.

Dod

idpickering
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Re: AstraZeneca PLC (AZN)

#388596

Postby idpickering » February 22nd, 2021, 7:05 am

Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US.



AstraZeneca today announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the Food and Drug Administration (FDA).

In May 2017, Imfinzi was granted accelerated approval in the US based on promising tumour response rates and duration of response data from Study 1108, a Phase I/II trial that evaluated the safety and efficacy of Imfinzi in advanced solid tumours, including previously treated bladder cancer. Continued approval was contingent on results from the DANUBE Phase III trial in the 1st-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020. The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation. This withdrawal does not impact the indication outside the US and does not impact other approved Imfinzi indications within or outside the US.

https://www.investegate.co.uk/astrazene ... 00088607P/

monabri
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Re: AstraZeneca PLC (AZN)

#391253

Postby monabri » March 1st, 2021, 5:57 pm

The Times reports that AZN has disposed of it's stake in Moderna.

https://www.thetimes.co.uk/article/astr ... -njjcs3r6b

( behind a paywall). There doesn't appear to have been any formal announcement.

"The cash from the Moderna share sale, thought to be about $1.2 billion, will bolster Astra’s finances as it develops its own drugs pipeline and completes its biggest acquisition, the $39 billion purchase of Alexion, an American rare diseases specialist"

"It is not clear when and over what period Astra sold its full holding in Moderna. A spokesman for the company declined to comment. "

PinkDalek
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Re: AstraZeneca PLC (AZN)

#391289

Postby PinkDalek » March 1st, 2021, 8:04 pm

monabri wrote:The Times reports that AZN has disposed of it's stake in Moderna.


I haven't accessed The Time article but the version I saw https://finance.yahoo.com/news/astrazeneca-sold-stake-moderna-more-230711198.html includes:

Sun, February 28, 2021, 11:07 PM (Reuters) - AstraZeneca sold its stake in rival COVID-19 vaccine maker Moderna for roughly $1 billion over the course of last year ...

tjh290633
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Re: AstraZeneca PLC (AZN)

#391332

Postby tjh290633 » March 1st, 2021, 11:13 pm

From https://www.investegate.co.uk/astrazene ... 00036947O/

The increase in Net Cash Inflow before Financing Activities was a result of the aforementioned improvement in Net Cash Inflow from Operating Activities, as well as a $1,363m increase in the Disposal of Non-Current Asset Investments to $1,381m. AstraZeneca sold part of its equity portfolio in the year, a large proportion of which related to the disposal of its full holding in Moderna Therapeutics, Inc. All related gains were accounted through Other Comprehensive Income.


It's there if you look. Dateline 11th february 2021.

TJH

idpickering
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Re: AstraZeneca PLC (AZN)

#391380

Postby idpickering » March 2nd, 2021, 9:20 am

Further update on US regulatory review of roxadustat in anaemia of chronic kidney disease.

AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. Roxadustat is under regulatory review for the treatment of anaemia of chronic kidney disease (CKD).

AstraZeneca and FibroGen are committed to working with the FDA ahead of the meeting and to bringing roxadustat to patients with anaemia of CKD. A date for the advisory committee meeting has not been determined.


https://www.investegate.co.uk/astrazene ... 00037800Q/

idpickering
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Re: AstraZeneca PLC (AZN)

#392330

Postby idpickering » March 4th, 2021, 3:39 pm

Designation of EU home member state

Following the exit of the United Kingdom from the European Union, AstraZeneca PLC (AstraZeneca) announces that it has selected Sweden as its home member state for EU securities regulation purposes pursuant to the Swedish Securities Market Act (Sw. lagen (2007.528) om värdepappersmarknaden).

AstraZeneca will file certain regulatory information with the Swedish Financial Supervisory Authority in accordance with applicable EU and Swedish law. These filings will be in addition to AstraZeneca's continuing disclosure obligations under applicable UK law, including the UK Disclosure Guidance and Transparency Rules. AstraZeneca's status as a UK PLC and the location of its headquarters in the United Kingdom remain unchanged.

AstraZeneca's selection of Sweden as its home member state for EU securities regulation purposes also means that certain continuing notification obligations pursuant to Swedish law will apply to dealings or interests in AstraZeneca securities in addition to the existing obligations under the UK Disclosure Guidance and Transparency Rules. These include notifications as soon as holdings of financial instruments or short positions reach, exceed or go below certain thresholds. AstraZeneca recommends its shareholders to inform themselves about the notification obligations under Swedish law and to consult with their legal advisers in case of any questions.


https://www.investegate.co.uk/astrazene ... 00012345R/

csearle
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Re: AstraZeneca PLC (AZN)

#392514

Postby csearle » March 4th, 2021, 10:37 pm

So is this the way forwards? Big firms will endeavour to have one foot in the EU and one foot in the UK to allow them to continue as friction-freely as possible. Sounds ok. They have the choice of exactly with EU member state to choose dependent upon their existing operations.

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Re: AstraZeneca PLC (AZN)

#395996

Postby daveh » March 16th, 2021, 8:51 am

Deal to supply additional doses of AZD7442 to US government
https://www.investegate.co.uk/astrazene ... 00103822S/

AstraZeneca to supply the US with up to half a million additional
doses of the potential COVID-19 antibody treatment AZD7442


Agreement builds on an earlier announcement that included support for the clinical development and supply of the treatment

AstraZeneca has modified an existing agreement with the US Government to supply up to 500,000 additional doses of AZD7442, a long-acting antibody (LAAB) combination which is in late-stage development for the prevention and treatment of COVID-19.



Lets hope this is not at cost, but at a price from which AZN will make a profit.

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Re: AstraZeneca PLC (AZN)

#396077

Postby idpickering » March 16th, 2021, 11:08 am

Divestment of Viela shareholding completed

AstraZeneca has completed the divestment of its 26.7% ownership in Viela Bio, Inc. (Viela), as part of the proposed acquisition of Viela by Horizon Therapeutics plc. This follows the agreement to divest the shareholding on 1 February 2021 .

Financial considerations

AstraZeneca has received cash proceeds and profit of c.$775m. This will be accounted for in other operating income in the Company's financial statements. The divestment does not impact the Company's financial guidance for 2021.


https://www.investegate.co.uk/astrazene ... 05053824S/

idpickering
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Re: AstraZeneca PLC (AZN)

#396811

Postby idpickering » March 18th, 2021, 4:14 pm

Benefits of AstraZeneca vaccine 'far outweigh' any possible risk, says government drug safety adviser

Prof Sir Munir Pirmohamed, chair of the Commission on Human Medicines, which advises government on the safety of medicines, has said the benefits of using the AstraZeneca vaccine “far outweigh” the risk.


https://www.theguardian.com/politics/li ... 49c13593a4

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Re: AstraZeneca PLC (AZN)

#396886

Postby PinkDalek » March 18th, 2021, 7:20 pm

idpickering wrote:Benefits of AstraZeneca vaccine 'far outweigh' any possible risk, says government drug safety adviser ...


If of any interest, there are lengthy topics on the subject over at Coronavirus Discussions, such as this one:

viewtopic.php?p=396753#p396753

idpickering
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Re: AstraZeneca PLC (AZN)

#396964

Postby idpickering » March 19th, 2021, 4:02 am

PinkDalek wrote:
idpickering wrote:Benefits of AstraZeneca vaccine 'far outweigh' any possible risk, says government drug safety adviser ...


If of any interest, there are lengthy topics on the subject over at Coronavirus Discussions, such as this one:

viewtopic.php?p=396753#p396753


Thanks for that. I chose to put my op here as AZN have been given a metaphoric kicking by the EU of late, and this info was important for AZN shareholders, me included, to be aware of.

Ian.

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Re: AstraZeneca PLC (AZN)

#397820

Postby idpickering » March 22nd, 2021, 7:06 am

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis



79% vaccine efficacy at preventing symptomatic COVID-19

100% efficacy against severe or critical disease and hospitalisation

Comparable efficacy result across ethnicity and age,
with 80% efficacy in participants aged 65 years and over

Favourable reactogenicity and overall safety profile


The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.

This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.

Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.

The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”



https://www.astrazeneca.com/content/ast ... point.html

RNS here; https://www.investegate.co.uk/astrazene ... 00089925S/

Dod101
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Re: AstraZeneca PLC (AZN)

#397824

Postby Dod101 » March 22nd, 2021, 7:53 am

Thanks Ian

This news is reassuring for shareholders except of course that AstraZeneca is supplying the vaccine at cost so long as the WHO declares Covid 19 a pandemic so there is not really a lot in it for them in the meantime.

Dod

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Re: AstraZeneca PLC (AZN)

#398793

Postby idpickering » March 25th, 2021, 7:36 am

AZD1222 US Phase III primary analysis confirms safety and efficacy

76% vaccine efficacy against symptomatic COVID-19

100% efficacy against severe or critical disease and hospitalisation

85% efficacy against symptomatic COVID-19 in participants aged 65 years and over

Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021.


https://www.investegate.co.uk/astrazene ... 00094637T/

I'm getting my COVID jab today. Not sure it'll be the AZN one though. Either way, I'm not worried.

Ian.

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Re: AstraZeneca PLC (AZN)

#400365

Postby idpickering » March 30th, 2021, 4:25 pm

This was mentioned on Bloomberg TV an hour ago;

Germany to Recommend AstraZeneca Vaccine Use Only for People Over 60

Germany will change its recommendation on AstraZeneca Plc’s Covid-19 vaccine and say it should only be used for women and men older than 60, after new data emerged on potential side effects.

The country’s vaccination commission has drafted a decision paper that recommends the shots only for older people but leaves open the possibility to administer it to younger people at a doctor’s discretion, according to a person familiar with the document.

Chancellor Angela Merkel has scheduled a press conference on Tuesday evening to comment on the further use AstraZeneca, while the commission itself is only expected to make a final decision on Thursday.


https://www.msn.com/en-us/news/world/ge ... NewsSearch

AZN down over 1.4% as I type. As to whether that's because of this matter, who knows? It won't budge me from continuing to hold my AZN shares.

Ian.

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Re: AstraZeneca PLC (AZN)

#400424

Postby absolutezero » March 30th, 2021, 7:53 pm

idpickering wrote:This was mentioned on Bloomberg TV an hour ago;

Germany to Recommend AstraZeneca Vaccine Use Only for People Over 60

Germany will change its recommendation on AstraZeneca Plc’s Covid-19 vaccine and say it should only be used for women and men older than 60, after new data emerged on potential side effects.

The country’s vaccination commission has drafted a decision paper that recommends the shots only for older people but leaves open the possibility to administer it to younger people at a doctor’s discretion, according to a person familiar with the document.

Chancellor Angela Merkel has scheduled a press conference on Tuesday evening to comment on the further use AstraZeneca, while the commission itself is only expected to make a final decision on Thursday.


https://www.msn.com/en-us/news/world/ge ... NewsSearch

AZN down over 1.4% as I type. As to whether that's because of this matter, who knows? It won't budge me from continuing to hold my AZN shares.

Ian.

Silly b*ggers playing games again I see.

idpickering
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Re: AstraZeneca PLC (AZN)

#402336

Postby idpickering » April 7th, 2021, 3:13 pm

I located this item after the subject was mentioned on Bloomberg TV this afternoon;

EU drug regulator says AstraZeneca shot benefit outweighs risk

AstraZeneca's covid-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

Says in reaching conclusion, committee took into consideration all currently available evidence, including the advice from an ad hoc expert group
— PiQ (@PriapusIQ)

PRAC noted that blood clots occurred in veins in brain and the abdomen (splanchnic vein thrombosis) and in arteries

EMA confirms overall benefit-risk for AstraZeneca's covid-19 vaccine remains positive


https://www.forexfactory.com/news/10730 ... -outweighs

absolutezero
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Re: AstraZeneca PLC (AZN)

#402443

Postby absolutezero » April 7th, 2021, 9:53 pm

idpickering wrote:I located this item after the subject was mentioned on Bloomberg TV this afternoon;

EU drug regulator says AstraZeneca shot benefit outweighs risk

AstraZeneca's covid-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

Says in reaching conclusion, committee took into consideration all currently available evidence, including the advice from an ad hoc expert group
— PiQ (@PriapusIQ)

PRAC noted that blood clots occurred in veins in brain and the abdomen (splanchnic vein thrombosis) and in arteries

EMA confirms overall benefit-risk for AstraZeneca's covid-19 vaccine remains positive


https://www.forexfactory.com/news/10730 ... -outweighs

Priapus. Interesting name.... :lol:

"AZ shot outweighs risk". Basically the same argument for all prescription medicines!
The risk of blood clots from taking the contraceptive pill are higher than blood clots after having the AZ vaccine.
Not about that priapus...


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