AstraZeneca PLC (AZN)

[idpickering]

Lynparza approved in the EU for pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in the European Union (EU) for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate among the most common cancers.1 Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.2

The approval by the European Commission was based on results from the Phase III POLO trial, which were published in The New England Journal of Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

https://www.investegate.co.uk/astrazene ... 00053706S/

[idpickering]

Lynparza approved in the EU for pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in the European Union (EU) for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate among the most common cancers.1 Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.2

The approval by the European Commission was based on results from the Phase III POLO trial, which were published in The New England Journal of Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

https://www.investegate.co.uk/astrazene ... 00053706S/

With respect to those suffering this dreadful illness, this is good news for AZN, and it's shareholders I think.
I hold AZN in my HYP alongside GSK in the sector, and together they form 9% in capital value terms, of my HYP. I have topped up GSK recently, and would love to buy more AZN, but they're a bit pricey for me now. I suspect they're set to get a bit more pricey too.

Ian.

[idpickering]

Brilinta granted US FDA Priority Review for stroke

AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA) .

https://www.investegate.co.uk/astrazene ... 00075186S/

[idpickering]

COVID-19 vaccine AZD1222 showed robust immune responses in all participants in Phase I/II trial

Interim data showed strong antibody and T-cell responses

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.

COV001 is a blinded, multi-centre, randomised controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed a single dose of AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten participants also received two doses of AZD1222 one month apart.

The results published in The Lancet confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection.

Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose. The levels of neutralising antibodies seen in participants receiving either one or two doses were in a similar range to those seen in convalescent COVID-19 patients. Strong correlations were observed across neutralisation assays.

The early safety responses confirmed that transient local and systemic reactions were common in the AZD1222 group and were comparable to previous trials and other adenoviral vector vaccines.1-4 They included temporary injection site pain and tenderness, mild-to-moderate headache, fatigue, chills, feverishness, malaise and muscle ache. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol, a pain killer, and occurred less frequently after a second dose.

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

RNS re the above here; https://www.investegate.co.uk/astrazene ... 41345251T/

[idpickering]

AstraZeneca enters collaboration in oncology

AstraZeneca and Daiichi Sankyo enter collaboration to
develop and commercialise new antibody drug conjugate

Potential new medicine DS-1062 could redefine treatment
standards in lung, breast and multiple other cancers

AstraZeneca has entered into a new global development and commercialisation agreement with Daiichi Sankyo Company, Limited (Daiichi Sankyo) for DS-1062, Daiichi Sankyo's proprietary trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) and potential new medicine for the treatment of multiple tumour types.

https://www.investegate.co.uk/astrazene ... 00091361U/

[idpickering]

Imfinzi recommended for EU approval in SCLC

Imfinzi recommended for approval in the EU by
CHMP for extensive-stage small cell lung cancer

Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit
and improved response rate in combination with a choice of chemotherapies

AstraZeneca's Imfinzi (durvalumab) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.1,2

https://www.investegate.co.uk/astrazene ... 05051365U/

[idpickering]

Calquence receives positive CHMP opinion for CLL

Calquence recommended for approval in the
EU by CHMP for chronic lymphocytic leukaemia

Recommendation based on two Phase III trials demonstrating superior progression-free survival across multiple settings while maintaining favourable tolerability

AstraZeneca's Calquence (acalabrutinib) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.1

https://www.investegate.co.uk/astrazene ... 10061366U/

[seekingbalance]

What a transformation in this company since it restarted proper drug research and stopped just cutting costs!

[idpickering]

Farxiga DAPA-CKD trial met all endpoints

Farxiga met all primary and secondary endpoints in groundbreaking Phase III DAPA-CKD trial for the treatment of patients with chronic kidney disease

Farxiga significantly reduced the worsening of renal function or risk of death

in patients with chronic kidney disease with and without type-2 diabetes

High-level results from Farxiga's (dapagliflozin) Phase III DAPA-CKD trial showed a statistically significant and clinically meaningful effect on its primary endpoint of a composite of worsening of renal function or risk of death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end stage kidney disease (ESKD) or cardiovascular (CV) or renal death) in adult patients with chronic kidney disease (CKD). The trial also met all its secondary endpoints in CKD patients with and without type-2 diabetes (T2D), making Farxiga the first medicine to significantly reduce the risk of death from any cause in this patient population.

https://www.investegate.co.uk/astrazene ... 00043043U/

[idpickering]

AZN: H1 2020 results

https://www.investegate.co.uk/astrazene ... 18185861U/

[idpickering]

Imfinzi US Priority Review; four-week, fixed dose

AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.

https://www.investegate.co.uk/astrazene ... 00054283W/

[idpickering]

Imfinzi approved in Japan for SCLC

AstraZeneca's Imfinzi (durvalumab) has been approved in Japan for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide plus a choice of platinum chemotherapy (either carboplatin or cisplatin). SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy.1,2

https://www.investegate.co.uk/astrazene ... 00038089W/

[idpickering]

Ph I trial begins for COVID-19 monoclonal antibody

The first participants have been dosed in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19.

The trial, called NCT04507256, will evaluate the safety, tolerability and pharmacokinetics of AZD7442.1 The trial will include up to 48 healthy participants in the UK aged 18 to 55 years and is funded by the Defense Advanced Research Projects Agency (DARPA), part of the US Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat COVID-19. This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance."

Should AZD7442 prove to be tolerated and have a favourable safety profile in the trial, AstraZeneca will progress it into larger late-stage Phase II and Phase III trials to evaluate its efficacy as a potential preventative and treatment approach against COVID-19.

https://www.investegate.co.uk/astrazene ... 00050189X/

[idpickering]

Oxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222

Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, announced today that it has signed an 18 month supply agreement under a three year Master Supply and Development Agreement ("the Agreement") with AstraZeneca UK Ltd ("AstraZeneca") for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period for AZD1222 by a further 18 months into 2022 and 2023 by mutual agreement.

Under the terms of the Agreement, AstraZeneca will pay Oxford Biomedica £15million upfront as a capacity reservation fee. Subject to satisfactory scale up of manufacturing capacity and continuation of the vaccine programme, Oxford Biomedica expects to receive additional revenue in excess of £35million plus certain materials costs for the manufacture of multiple large-scale batches of AZD1222 until the end of 2021.

https://www.investegate.co.uk/oxford-bi ... 00105492X/

[idpickering]

Two more announcements put out today by AZN.

Imfinzi approved in EU for small cell lung cancer

AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.

https://www.investegate.co.uk/astrazene ... 00115610X/

Farxiga reduces CKD progression and risk of death

Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca's Farxiga (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type-2 diabetes (T2D). CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide,1,2 many of them still undiagnosed,3,4 and the most common causes are diabetes, hypertension and glomerulonephritis.5

https://www.investegate.co.uk/astrazene ... 00105428X/

[idpickering]

AstraZeneca Halts Coronavirus Vaccine Trials Over Suspected Serious Adverse Reaction In Volunteer

he British-Swedish drug giant AstraZeneca PLC announced Tuesday it had paused its late-stage trials of a potential COVID-19 vaccine after a study participant developed an unexplained illness.

The multinational pharmaceutical company had been testing a potential vaccine in the United Kingdom, where a volunteer suffered a severe possible side effect. The suspected adverse reaction to the drug prompted researchers to temporarily halt its program to conduct an investigation, the New York Times reported.

Pausing global trials is a standard precaution to ensure that experimental vaccines don’t cause severe reactions among volunteers. Vaccine trials often see several adverse events, such as fever, headaches, soreness, and muscle pain.

AstraZeneca did not release details about the nature of the illness or when it happened but called the decision to pause the trial precautionary. According to a source familiar with the case, the test subject in question is expected to recover.

https://www.ibtimes.com/astrazeneca-hal ... on-3042428

The stock may well be cheaper on this when the market opens, and present a buying opportunity? Although tbh, I have enough of their shares in my HYP already.

Ian.

[idpickering]

Fasenra met both co-primary endpoints of reduced nasal polyp size and blockage in the OSTRO Phase III trial for patients with chronic rhinosinusitis with nasal polyps

High-level results from the OSTRO Phase III trial showed AstraZeneca's Fasenra (benralizumab) compared with placebo demonstrated a statistically significant improvement in the size of nasal polyps and in nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Fasenra demonstrated a statistically significant improvement in the endoscopic total nasal polyp score (NPS) and the nasal blockage score (NBS) compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care (SoC). SoC consists of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. Evaluation of NPS was based on a physician assessment of polyp size during endoscopy. NBS evaluation was based on a patient-reported symptoms diary.

https://www.investegate.co.uk/astrazene ... 00065940Y/

[idpickering]

Tagrisso reduced early lung cancer brain recurrence

Results from a prespecified exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca's Tagrisso (osimertinib) demonstrated a clinically meaningful improvement in central nervous system (CNS) disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), after complete tumour resection.

https://www.investegate.co.uk/astrazene ... 00065021Z/

Lynparza EU recommendation in ovarian cancer

AstraZeneca and MSD's Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.

https://www.investegate.co.uk/astrazene ... 00075524Z/

Lynparza EU recommendation in prostate cancer

AstraZeneca and MSD's Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.

https://www.investegate.co.uk/astrazene ... 05075527Z/

[idpickering]

COVID-19 antibodies advance and get US funding

AstraZeneca's long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside the US that are due to begin in the next weeks. The LAABs have been engineered with AstraZeneca's proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration. The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

The Company has received support of around $486m from the US Government for the development and supply of AZD7442 under an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Department of Defence Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defence.

Full item here;

https://www.investegate.co.uk/astrazene ... 00077043B/

[idpickering]

Forxiga HF receives positive CHMP opinion

https://www.investegate.co.uk/astrazene ... 00164475C/

Trixeo Aerosphere receives positive CHMP opinion

https://www.investegate.co.uk/astrazene ... 00074474C/