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AstraZeneca PLC (AZN)

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idpickering
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AstraZeneca PLC (AZN)

#198202

Postby idpickering » February 1st, 2019, 3:57 pm

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxiga (dapagliflozin), after adopting a positive opinion for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).


https://www.investegate.co.uk/astrazene ... 17558703O/

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Re: AstraZeneca - Forxiga receives positive EU CHMP opinion

#198208

Postby moorfield » February 1st, 2019, 4:12 pm

Good news (I think). :?

For the next 57 days at least, after which it becomes illegal I wonder ... :shock:

idpickering
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AstraZeneca - EMA grants PRIME eligibility for MEDI8897

#198979

Postby idpickering » February 5th, 2019, 7:20 am

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Medicines Agency (EMA) has granted access to its PRIME (PRIority MEdicines) scheme for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.



The PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimise development plans and accelerate evaluation so these medicines can reach patients faster. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.



Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said: "We are excited to receive PRIME eligibility for MEDI8897, our next-generation monoclonal antibody targeting respiratory syncytial virus in infants. We will work closely with the European Medicines Agency to optimise our development plan and help us bring MEDI8897 to patients as quickly as possible."



This is the first EMA PRIME eligibility that AstraZeneca has received since the programme's initiation. It is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, which met its primary endpoint defined as a statistically-significant reduction in the incidence of medically-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV for 150 days after dosing in healthy preterm infants. Full results from the Phase IIb trial will be presented at a forthcoming medical meeting.

https://www.investegate.co.uk/astrazene ... 00070836P/

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Re: AstraZeneca - EMA grants PRIME eligibility for MEDI8897

#199037

Postby moorfield » February 5th, 2019, 11:26 am

Thanks Ian.

More temporary good news for AZN shareholders.

52 days to go. :o

idpickering
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AstraZeneca PLC (AZN)

#199213

Postby idpickering » February 6th, 2019, 7:06 am

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome (HES).

HES is a group of rare, potentially fatal disorders characterised by high numbers of eosinophils in blood and tissues, which can cause progressive damage to any organ in the body.1,2 The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.


https://www.investegate.co.uk/astrazene ... 00021778P/

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Re: AstraZeneca Plc (AZN)

#203623

Postby daveh » February 25th, 2019, 8:24 am

Brilinta's PHIII THEMIS trail met primary endpoint.

www.investegate.co.uk/article.aspx?id=2 ... 9749Q&fe=1

The Phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone.


So it successfully reduced stroke and heart attack in the target population (Type 2 diabetics with coronary artery disease) compared to aspirin alone.

idpickering
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Re: AstraZeneca Plc (AZN)

#203858

Postby idpickering » February 26th, 2019, 8:20 am

Lynparza significantly delayed disease progression

Lynparza significantly delayed disease progression as 1st-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer


https://www.investegate.co.uk/astrazene ... 00261143R/

idpickering
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Re: AstraZeneca PLC (AZN)

#204558

Postby idpickering » February 28th, 2019, 1:22 pm

This from TMF;

Retirement saving: I think AstraZeneca could help you to accumulate £1 million

The performance of AstraZeneca (LSE: AZN) has started to improve significantly in recent quarters. The FTSE 100 pharma stock has returned to growth after what has been a long and arduous journey. It has suffered from the impact of patent losses, with its financial performance having disappointed significantly in recent years.

Now, though, growth is expected to continue over the long run. As such, now could be a time to buy it at a moment when a number of FTSE 100 shares, including one that reported on Thursday, may be overvalued after the index’s strong start to 2019.


https://www.fool.co.uk/investing/2019/0 ... 1-million/

idpickering
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Re: AstraZeneca PLC (AZN)

#208325

Postby idpickering » March 18th, 2019, 7:15 am

US FDA grants saracatinib ODD for IPF

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for saracatinib, a potential new medicine for the treatment of idiopathic pulmonary fibrosis (IPF), a type of lung disease that results in scarring (fibrosis) of the lungs. Saracatinib is an inhibitor of src kinase which regulates broad cell functions including cell growth and cell differentiation.1 Saracatinib has completed Phase I development.


https://www.investegate.co.uk/astrazene ... 00050958T/

idpickering
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Re: AstraZeneca PLC (AZN)

#210549

Postby idpickering » March 27th, 2019, 7:11 am

Forxiga approved in Japan for type-1 diabetes

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).

Elisabeth Björk, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, said: "This approval of Forxiga in Japan means that people with type-1 diabetes whose glucose levels are not adequately controlled with insulin alone now have a new oral treatment option available to them. Forxiga will help address a significant unmet need in this patient population, and this approval in type-1 diabetes builds on the well-established clinical profile of Forxiga."


https://www.investegate.co.uk/astrazene ... 00051398U/

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Re: AstraZeneca PLC (AZN)

#211195

Postby Steveam » March 29th, 2019, 8:02 am

Signs collaboration agreement and will pay contingent payments upto $5.55bn and will do share placement of about $3.5bn to help fund.

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

https://www.astrazeneca.com/media-centr ... lease.html

Best wishes,

Steve

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Re: AstraZeneca PLC (AZN)

#211271

Postby daveh » March 29th, 2019, 1:06 pm

[Deletion]

I think it is rather a lot of money to pay for a drug yet to receive full approval with a large amount of the money up front. The placing is for ~4.5% of the company. It seems a lot for a single drug.
Moderator Message:
Reference to off-topic material removed. - Chris

idpickering
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Re: AstraZeneca PLC (AZN)

#211780

Postby idpickering » April 1st, 2019, 7:11 am

Selumetinib gets Breakthrough Therapy Designation

AstraZeneca and MSD, Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the MEK 1/2 inhibitor and potential new medicine selumetinib.


https://www.investegate.co.uk/astrazene ... 00065796U/

idpickering
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Re: AstraZeneca PLC (AZN)

#217389

Postby idpickering » April 26th, 2019, 7:19 am


idpickering
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Re: AstraZeneca PLC (AZN)

#226386

Postby idpickering » June 3rd, 2019, 7:09 am

Lynparza nearly doubled the time patients lived without disease progression from germline BRCA-mutated metastatic pancreatic cancer.

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced detailed results from the Phase III POLO trial at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US (Abs #LBA4). Results are today also published in The New England Journal of Medicine (NEJM).

The POLO trial tested Lynparza (olaparib) tablets as 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease had not progressed following standard-of-care platinum-based 1st-line chemotherapy.

Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza vs. placebo, improving the time without disease progression by a median of 7.4 months for patients treated with Lynparza vs. 3.8 months for those on placebo (HR 0.53 [95% CI, 0.35-0.82], p=0.004). More than twice as many patients showed no disease progression both at one year (34% on Lynparza vs. 15% on placebo) and two years (22% vs. 10%, respectively).

https://www.investegate.co.uk/astrazene ... 00098502A/

idpickering
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Re: AstraZeneca PLC (AZN)

#230045

Postby idpickering » June 17th, 2019, 7:09 am

Calquence significantly prolonged the time patients lived without disease progression in relapsed or refractory chronic lymphocytic leukaemia.



AstraZeneca today announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association (EHA) Annual Congress in Amsterdam, showing Calquence (acalabrutinib) significantly prolonged the time patients live without disease progression in relapsed or refractory chronic lymphocytic leukaemia (CLL).


https://www.investegate.co.uk/astrazene ... 00064350C/

idpickering
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Re: AstraZeneca PLC (AZN)

#230633

Postby idpickering » June 19th, 2019, 7:11 am

Three announcements today;

Bevespi Aerosphere approved by the Japanese - https://www.investegate.co.uk/astrazene ... 00046828C/

Lynparza approved in Japan for 1st-line - https://www.investegate.co.uk/astrazene ... 00046833C/

Breztri Aerosphere (PT010) approved in Japan for patients with chronic obstructive pulmonary disease. - https://www.investegate.co.uk/astrazene ... 00046837C/

I hold, have trimmed in the past, but am now leaving well alone.

Ian.

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Re: AstraZeneca PLC (AZN)

#232274

Postby daveh » June 27th, 2019, 8:50 am

Another positive trail outcome:
Imfinzi improves overall survival at interim
http://www.investegate.co.uk/article.as ... 5761D&fe=1
AstraZeneca today announced positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients.

idpickering
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Re: AstraZeneca PLC (AZN)

#233028

Postby idpickering » July 1st, 2019, 7:17 am

Forxiga receives positive EU CHMP opinion for DECLARE-TIMI 58 cardiovascular outcomes data;

https://www.investegate.co.uk/astrazene ... 00089322D/

Fasenra receives positive EU CHMP opinion for self-administration and the new Fasenra pen, a pre-filled, single-use auto-injector

https://www.investegate.co.uk/astrazene ... 00089313D/

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Re: AstraZeneca PLC (AZN)

#233034

Postby ADrunkenMarcus » July 1st, 2019, 7:41 am

:D

Best wishes

Mark.


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