AstraZeneca has been given approval in Japan for its Bevespi Aerosphere treatment for obstructive pulmonary disease and for the Lynparza ovarian cancer drug that it is developing with US pharmaceuticals group Merck & Co.
AstraZeneca Plc (AZN.L) Announced that Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD). This is the first global regulatory approval for Breztri Aerosphere and is the first approval by the Japanese Ministry of Health, Labour and Welfare for a triple-combination therapy in a pressurised metered-dose inhaler (pMDI), which uses the innovative Aerosphere delivery technology. It also stated, that Lynparza (olaparib) has been approved in Japan as a maintenance treatment after 1st-line chemotherapy in patients with BRCA-mutated (BRCAm) advanced ovarian cancer, as detected by an approved companion diagnostic test. Further it announced that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). This is the first approval by the Japanese Ministry of Health, Labour and Welfare for a maintenance fixed-dose, long-acting dual bronchodilator in a pressurised metered-dose inhaler (pMDI), which uses the innovative Aerosphere delivery technology.
First approval of a fixed-dose, long-acting dual bronchodilator in a pressurised metered-dose inhaler device in Japan. AstraZeneca today announced that Bevespi Aerosphere has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease.. Mene Pangalos, Executive...
Lynparza approved in Japan for 1st- line maintenance therapy in BRCA-mutated advanced ovarian cancer. AstraZeneca and MSD's Lynparza is the only PARP inhibitor approved in Japan. AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that Lynparza has been approved in Japan as a maintenance treatment after 1st- line chemotherapy in patients with...
Breztri Aerosphere approved in Japan for patients with chronic obstructive pulmonary disease. First global approval and only triple-combination therapy in a pressurised metered-dose inhaler device in Japan. AstraZeneca today announced that Breztri Aerosphere, formerly PT010, has been approved in Japan as a triple-combination therapy to relieve...
AstraZeneca Plc (AZN.L) Announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer
RNS Number: 5405 C AstraZeneca PLC 18 June 2019 18 June 2019 07:00 BST. Lynparza approved in the EU for 1st- line maintenance treatment of BRCA-mutated advanced ovarian cancer. AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that the European Commission has approved Lynparza as a 1st- line maintenance treatment for women with BRCA-mutated advanced...
AstraZeneca has announced positive results from interim analysis of Phase III trials of its Calquence treatment. The company says the drug “significantly prolonged” the time that patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) lived without a progression of the disease. CLL is the most common type of leukaemia in adults, with an estimated 191,000 new cases globally. Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma in the US, Brazil, the United Arab Emirates and Qatar and is being developed for the treatment of CLL and other blood cancers.
AstraZeneca Plc (AZN.L) 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). The ASCEND trial compared Calquence with the physician's choice of rituximab combined with idelalisib (IdR) or bendamustine (BR) in patients with relapsed or refractory CLL. At a median follow-up of 16.10 months, results from the trial showed a statistically significant and clinically-meaningful improvement in progression-free survival (PFS) for patients treated with Calquence vs. IdR or BR, reducing the risk of disease progression or death by 69.0%
RNS Number: 4350 C AstraZeneca PLC 17 June 2019 17 June 2019 07:00 BST. AstraZeneca today announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association Annual Congress in Amsterdam, showing Calquence significantly prolonged the time patients live without disease progression in relapsed or...
AstraZeneca today announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association Annual Congress in Amsterdam, showing CALQUENCE ® significantly prolonged the time patients lived without disease progression in relapsed or refractory chronic lymphocytic leukemia. This press release...
AstraZeneca today presented positive results from the Phase IIIb DIALIZE trial which investigated the efficacy and safety of LOKELMA for the treatment of hyperkalemia in patients with end-stage renal disease on hemodialysis. The results were presented as a late-breaking abstract at the 56th European Renal Association– European Dialysis and...
Following a routine technical update of the Company's Euro Medium Term Note programme established in 2007, the following prospectus has been approved by the UK Listing Authority and is available for viewing:. Base Prospectus for the AstraZeneca PLC U.S. $10,000,000,000 Euro Medium Term Note Programme.. RNS is approved by the Financial Conduct Authority to...
A pre-specified exploratory analysis of renal data from the Phase III DECLARE-TIMI 58 trial, the broadest cardiovascular outcomes trial of a sodium-glucose co-transporter 2 inhibitor, showed that FARXIGA reduced the progression of kidney disease or renal death in patients with type 2 diabetes. These data, presented today at the American Diabetes...
AstraZeneca Plc (AZN.L) Announced positive results from the Phase III ELEVATE-TN trial of Calquence in patients with previously untreated chronic lymphocytic leukaemia, the most common type of leukaemia in adults. The trial met primary endpoint and showed that Calquence in combination with obinutuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab. The trial also met a key secondary endpoint indicating that Calquence monotherapy achieved a statistically significant and clinically meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen.
RNS Number: 3502 B AstraZeneca PLC 06 June 2019 This announcement contains inside information. 6 June 2019 07:00 BST. Calquence Phase III ELEVATE-TN trial met primary endpoint at interim analysis in previously-untreated chronic lymphocytic leukaemia.
The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6. 1. As at 31 May 2019 the issued share capital of AstraZeneca PLC with voting rights is 1,311,776,898 ordinary shares of US $0.25. The above figure for the total number of voting rights may be used by shareholders as the denominator...
RNS Number: 8391 A AstraZeneca PLC 03 June 2019 3 June 2019 15:00 BST. Block Listing Six Monthly Return. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom.
AstraZeneca (AZN) announced that its Lynparza cancer drug, which is being co-developed with US outfit Merck & Co, has delivered “unprecedented” results in testing. The pharmaceutical giant claimed that the drug almost doubled the period patients lived without disease progression, with 22 per cent of patients remaining free of progression for two years, versus 10 per cent of those on placebo. Positive news, for sure, but we remain concerned about the regulatory environment and the group’s debt burden. Sell.
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Company Profile

A world-leading pharmaceutical group, AstraZeneca was created in 1999 via the merger of Sweden's Astra and the UK's Zeneca, which had been demerged from chemicals group ICI in 1993. About half of its total sales are generated from the US, with over a third of revenues coming from its gastrointestinal treatments such as Prilosec (Losec) and Nexium.

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HQ
Cambridge Biomedical Campus
1 Francis Crick Avenue
Cambridge
CB2 0AA
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