AstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in Chinafor the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients.
AstraZeneca today announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi).
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.
AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga(dapagliflozin) met theprimary 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.
AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer. The trial, in the 1st-line maintenance setting, compared Lynparza (olaparib) added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults.1
AstraZeneca today announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced positive results from the Phase III PROfound trial of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC) who have a *homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone).
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.
Fortsatt stark produktförsäljning styrker förtroendet för hållbar tillväxt Tillväxten i produktförsäljning under första halvåret på 12% (17% i fasta valutakurser1) till 11 183 MUSD innefattar en försäljningsacceleration under andra kvartalet till 5 718 MUSD (+14%, +19% i fasta valutakurser). Under andra kvartalet levererade alla försäljningsregioner och samtliga tre terapiområden goda resultat.
AstraZeneca today 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 today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC).
AstraZeneca today 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.
AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to add a self-administration option for Fasenra (benralizumab) and a new delivery method as a pre-filled, single-use auto-injector (the Fasenra pen) to the medicine’s product information in the European Union.
AstraZeneca today announced positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients.
AstraZeneca today 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).
AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced 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.
AstraZeneca today 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).
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.
AstraZeneca today 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).