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AstraZeneca PLC (AZN)
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- The full Lemon
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Re: AstraZeneca PLC (AZN)
I agree that a closer look at their numbers is quite encouraging. I will leave it there.
Dod
Dod
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Re: AstraZeneca PLC (AZN)
Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US.
https://www.investegate.co.uk/astrazene ... 00088607P/
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/
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- Lemon Half
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Re: AstraZeneca PLC (AZN)
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. "
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. "
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Re: AstraZeneca PLC (AZN)
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 ...
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- Lemon Half
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Re: AstraZeneca PLC (AZN)
From https://www.investegate.co.uk/astrazene ... 00036947O/
It's there if you look. Dateline 11th february 2021.
TJH
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
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Re: AstraZeneca PLC (AZN)
Further update on US regulatory review of roxadustat in anaemia of chronic kidney disease.
https://www.investegate.co.uk/astrazene ... 00037800Q/
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/
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Re: AstraZeneca PLC (AZN)
Designation of EU home member state
https://www.investegate.co.uk/astrazene ... 00012345R/
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/
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- Lemon Quarter
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Re: AstraZeneca PLC (AZN)
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)
Deal to supply additional doses of AZD7442 to US government
https://www.investegate.co.uk/astrazene ... 00103822S/
Lets hope this is not at cost, but at a price from which AZN will make a profit.
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)
Divestment of Viela shareholding completed
https://www.investegate.co.uk/astrazene ... 05053824S/
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/
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Re: AstraZeneca PLC (AZN)
Benefits of AstraZeneca vaccine 'far outweigh' any possible risk, says government drug safety adviser
https://www.theguardian.com/politics/li ... 49c13593a4
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)
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
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Re: AstraZeneca PLC (AZN)
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)
AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis
https://www.astrazeneca.com/content/ast ... point.html
RNS here; https://www.investegate.co.uk/astrazene ... 00089925S/
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/
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Re: AstraZeneca PLC (AZN)
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
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)
AZD1222 US Phase III primary analysis confirms safety and efficacy
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.
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)
This was mentioned on Bloomberg TV an hour ago;
Germany to Recommend AstraZeneca Vaccine Use Only for People Over 60
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.
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)
idpickering wrote:This was mentioned on Bloomberg TV an hour ago;
Germany to Recommend AstraZeneca Vaccine Use Only for People Over 60Germany 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.
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Re: AstraZeneca PLC (AZN)
I located this item after the subject was mentioned on Bloomberg TV this afternoon;
EU drug regulator says AstraZeneca shot benefit outweighs risk
https://www.forexfactory.com/news/10730 ... -outweighs
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
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Re: AstraZeneca PLC (AZN)
idpickering wrote:I located this item after the subject was mentioned on Bloomberg TV this afternoon;
EU drug regulator says AstraZeneca shot benefit outweighs riskAstraZeneca'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....
"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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