The Lemon Fool

AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.

Tagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer

Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous
system metastases lived without disease progression

AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo. The trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment, including those with and without type-2 diabetes

AstraZeneca today announced final overall survival (OS) results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients. The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumour mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumour, and tumours with high levels of TMB may be more visible to the immune system.1,2

idpickering wrote:Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. https://www.investegate.co.uk/astrazene ... 00078027K/

77ss wrote:

idpickering wrote:Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. https://www.investegate.co.uk/astrazene ... 00078027K/

AZN powers on. A big slice of luck here, by all accounts:

Due to heart complications caused by diabetes drugs in the past, regulators forced the drugmaker to conduct a cardiovascular safety study to ensure that Farxiga--which forces the kidney to remove glucose from the blood to and expel it in urine--wasn't dangerous. The trial revealed that not only was Farxiga harmless, it actually improved heart function.


https://www.marketwatch.com/story/astra ... siteid=rss

Dod101 wrote:

77ss wrote:

idpickering wrote:Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. https://www.investegate.co.uk/astrazene ... 00078027K/

AZN powers on. A big slice of luck here, by all accounts:

Due to heart complications caused by diabetes drugs in the past, regulators forced the drugmaker to conduct a cardiovascular safety study to ensure that Farxiga--which forces the kidney to remove glucose from the blood to and expel it in urine--wasn't dangerous. The trial revealed that not only was Farxiga harmless, it actually improved heart function.


https://www.marketwatch.com/story/astra ... siteid=rss

Hooray! Now over £75 per share.

Dod

grimer wrote:
My stop loss kicked in today at 7299p.

idpickering wrote:

grimer wrote:
My stop loss kicked in today at 7299p.

My first purchase of AZN shares was on 17 Nov 2009, buying at 2732p ps. My average purchase price since then, having topped up and top sliced periodically, but no more, is 4468p ps. I intend holding on to my shares going forward.

Ian.

AstraZeneca today announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D).

Financial considerations
Cheplapharm will pay AstraZeneca approximately $243 million on completion of the agreement, plus sales-contingent milestones of up to $33 million in 2021 and 2022. Income arising from the upfront payment will be reported in the Company's financial statements in 2019 as Other Operating Income. In 2018, Losec sales in the countries covered by this agreement were $98 million, the majority of which were in Emerging Markets. The agreement does not change the Company's financial guidance for 2019. As there were no closing considerations to the transaction, the agreement became effective upon signing.

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen).

The approval is supported by data from the Phase III GRECO trial and the Phase I AMES trial. The safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine.

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.