Data from the KRONOS trial presented at the European Respiratory Society (ERS) International Congress 2018
AstraZeneca and MedImmune, announced today that the US FDA has approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).
AstraZeneca and MedImmune, today announced that new data from the BORA Phase III extension trial of Fasenra (benralizumab) is among 43 company abstracts accepted for oral and poster presentation at the European Respiratory Society (ERS) International Congress 2018, 15-19 September in Paris.
AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
AstraZeneca and MedImmune, today announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLEas measured by the SLE Responder Index 4 (SRI4)at 12 months.
AstraZeneca today announced that the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorisation for Bydureon (exenatide extended release) for the treatment of patients with type-2 diabetes.
AstraZeneca today announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved 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.
New evidence of the persistency of ischaemic risk in post-heart attack patients, highlighting specific risk factors that may help identify patients for extended DAPT Latest data on the links between RAAS inhibitor dose reduction and increased risk of mortality and MACE in heart failure patients with hyperkalaemia
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 granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).
Recommended marketing authorisation for patients whose tumours express PD-L1 on ≥1% of tumour cells Imfinzi is the first immunotherapy recommended for approval for the treatment of locally-advanced, unresectable NSCLC
Starka resultat från nya läkemedel och tillväxtmarknaderna stödjer återgång till tillväxt under 2018
AstraZeneca has agreed to sell the commercial rights to Atacand(candesartan cilexetil)and AtacandPlus (fixed-dose combination of candesartan cilexetil and hydrochlorothiazide) in Europe to CheplapharmArzneimittel GmbH (Cheplapharm). Atacand is a prescription medicine for the treatment of heart failure and hypertension.
AstraZeneca meddelar i dag att Katarina Ageborg utsetts till ny VD för AstraZeneca AB. Hon tar över efter Jan-Olof Jacke den 1 augusti 2018 och kommer även fortsättningsvis rapportera till koncernchef Pascal Soriot.
Lynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer Second approval in Japan for AstraZeneca and MSD’s Lynparza
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the Japanese Ministry of Health, Labour and Welfare approved Imfinzi (durvalumab) as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).
AstraZeneca today announced that the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion, recommending inclusion of Bydureon (2mg prolonged-release suspension for injection) BCise device as a new formulation within the marketing authorisation for Bydureon (exenatide extended-release) for the treatment of type-2 diabetes.
AstraZeneca and MSD today announced positive results from the randomised, double-blinded, placebo-controlled, Phase III SOLO-1 trial of Lynparza (olaparib) tablets.
Key data evaluating the efficacy and safety of Farxiga (dapagliflozin) in combination with other type-2 diabetes therapies head-to-head vs. insulin or sulfonylurea Latest data from the DEPICT clinical programme evaluating Farxiga to address an unmet need for oral therapy in adult patients with type-1 diabetes
Independent data monitoring committee advises lanabecestat is unlikely to meet primary endpoints, leading to decision to discontinue these trials