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AstraZeneca

AstraZeneca

AstraZeneca is a global biopharmaceutical business founded in 1999.

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Pushkala Aripaka
February 14, 2020
IN
AstraZeneca forecast a likely slowdown in revenue growth this year, assuming a hit from China's coronavirus epidemic lasting up to a few months, although it added there had been limited disruption to its operations so far.
January 27, 2020
WebWire
High-level results from the Phase III THALES trial showed AstraZeneca's Brilinta (ticagrelor) 90mg used twice daily and taken with aspirin for 30 days, reached a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone. THALES was conducted in over 11,000 patients who had a minor acute ischaemic stroke or high-risk transient ischaemic attack (TIA) in the 24 hours prior to treatment initiati...
John Miller
January 27, 2020
U.S.
U.S. drugmaker AbbVie's $63 billion tie-up with Allergan is getting help from Nestle and AstraZeneca buying up products the Irish-domiciled company is shedding to placate regulators.
January 6, 2020
WebWire
AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). Farxiga is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2)...
Pushkala Aripaka
December 30, 2019
IN
AstraZeneca and Merck's ovarian cancer drug Lynparza has received U.S. regulatory approval for the treatment of advanced pancreatic cancer, cementing its lead in a niche category of cancer treatments.
December 2, 2019
WebWire
AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC). SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.1 A Prescription Drug User Fee Act date is set for th...
Reuters Editorial
November 6, 2019
IN
Indian drugmaker Sun Pharmaceutical Industries Ltd said on Wednesday it would introduce some of its cancer treatment drugs in China through Britain's AstraZeneca.
Wang Xueqiao
November 5, 2019
Financial Times
October 23, 2019
WebWire
AstraZeneca will extend funding for its award-winning Young Health Programme for a further five years with a pledge of $35m (£28m) to help to educate young people on the steps they can take to reduce the risk of non-communicable diseases. These diseases, which include cancer, diabetes, heart disease and heart failure, are responsible for the majority of deaths worldwide, and over two-thirds of those deaths can be directly attributed to behaviour that begins in adolescence.1,2 The Young...
October 7, 2019
WebWire
AstraZeneca 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. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "Fasenra ...
September 26, 2019
WebWire
AstraZeneca will present new data on its portfolio of inhaled combination and biologic therapies, and pipeline of emerging medicines at the European Respiratory Society (ERS) International Congress, which takes place from 28 September to 2 October in Madrid, Spain. The breadth and depth of science is reflected in the 65 abstracts accepted, including 17 oral presentations. In inhaled combinations, a new analysis from the Phase III KRONOS trial will be presented assessing the benefit of tr...
Reuters Editorial
September 16, 2019
IN
AstraZeneca's diabetes drug, Farxiga, has been granted fast track designation by U.S. regulators for the treatment of heart failure, boosting prospects of wider use of the drug and putting it ahead of rivals.
August 21, 2019
WebWire
AstraZeneca 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 tumou...
August 6, 2019
WebWire
AstraZeneca 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. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "For patients with type-2 diabetes, heart failure is one of t...
July 15, 2019
WebWire
AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycaemic control. AstraZeneca will work closely with the FDA to discuss the next steps. Farxiga was recently approved in Europe (5mg) and Japan (5mg,...
July 2, 2019
WebWire
AstraZeneca announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the Phase III DECLARE-TIMI 58 trial. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "We are pleased with this positive opinion for the cardiovascular outcomes and renal dat...
Daiichi Sankyo Company, Limited
May 8, 2019
www.prnewswire.com:443
TOKYO and MUNICH and BASKING RIDGE, N.J., May 8, 2019 /PRNewswire/ -- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today...
Persistence Market Research Pvt. Ltd.
Invalid Date
www.prnewswire.com:443
NEW YORK, Feb. 13, 2019 /PRNewswire/ -- Rise in the prevalence of chronic kidney disease is the key factor responsible for the growth of Renal Anemia Treatment ...
February 6, 2019
WebWire
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 tha...
January 8, 2019
WebWire
AstraZeneca is announcing organisational changes to support continued scientific innovation and commercial success in the main therapy areas as the Company enters a new phase in its strategic development. Included in the changes will be the arrival at AstraZeneca of the world-renowned oncology scientist, José Baselga, as well as the creation of: , , , , , , • Therapy area-focused Research and Development units that are responsible for discovery through to late-stage development - one for BioPh...
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