Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved AstraZeneca’s Tagrisso (osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review. The approval is based on results from the global Phase III Flaura trial which included Japanese patients and which were published…
AstraZeneca Sells Atacand To Cheplapharm
AstraZeneca has agreed to sell the commercial rights to Atacand (candesartan cilexetil) and Atacand Plus (fixed-dose combination of candesartan cilexetil and hydrochlorothiazide) in Europe to Cheplapharm Arzneimittel GmbH (Cheplapharm). Atacand is a prescription medicine for the treatment of heart failure and hypertension. Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca Mark Mallon said, “This agreement forms part of our strategy of…
AstraZeneca’s Imfinzi Extends Survival For Non-Small Cell Lung Cancer Patients
AstraZeneca and MedImmune, its global biologics research and development arm, announced positive overall survival (OS) results for the Phase III PACIFIC trial, a randomized, double-blinded, placebo-controlled, multi-center trial of Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). A planned…
AstraZeneca’s Lokelma Approved For The Treatment Of Adult Hyperkalemia
The FDA has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalemia,1 a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.2 The risk of hyperkalemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure…
AstraZeneca And Merck Receive EU Approval
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the European Medicines Agency (EMA) has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete…
FDA Accepts Biologics License Application for Moxetumomab Pasudotox in Hairy Cell Leukaemia
Lokelma Approved in the EU for the Treatment of Adults with Hyperkalaemia
Study Confirms CV Benefits for Type 2 Diabetes Patients Using SGLT-2 Inhibitors
EMA Accepts Regulatory Submission for Forxiga in Adults with Type-1 Diabetes
Brilinta Reduces CV Events, Coronary Death Beyond One Year in Heart Attack Survivors
AstraZeneca Reports Top-line Phase III KRONOS Trial Results
AstraZeneca Receives EU Approval Of Fasenra For Severe Eosinophilic Asthma
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.1 The approval is based on the results from the WINDWARD program, including the pivotal Phase III exacerbation…
EU Approves AstraZeneca’s Fasenra for Asthma
FDA Accepts Supplemental New Drug Application For AstraZeneca’s Tagrisso
U.S. FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer. AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous…
