AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
First Phase III trial to demonstrate survival benefit in this adjuvant setting.
Results showed that Imfinzi-based treatment before and after surgery significantly increased the time patients live without recurrence or progression events.
Positive high-level results from an analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pretreated patients.
AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
AstraZeneca announced today the successful completion of the acquisition of CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
AstraZeneca and KYM Biosciences Inc.i have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancer. Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally.
AstraZeneca’s tablet formulation of Calquence (acalabrutinib) has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).
AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers.
AstraZeneca will showcase new data across its Vaccines and Immune Therapies Respiratory Syncytial Virus (RSV) portfolio at the 7th Respiratory Syncytial Virus Foundation (ReSViNET) Conference in Lisbon, Portugal from 22-24 February 2023, reinforcing its commitment to help protect infants from RSV.
Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone demonstrated median overall survival (OS) of 42.1 months versus 34.7 months for abiraterone plus placebo.
Resultat för helåret och fjärde kvartalet 2022 Starkt resultat för verksamheten och framsteg med portföljen under 2022 stödjer utsikten för 2023 På väg att leverera branschledande tillväxt fram till 2025 och framåt
Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.
The US Food and Drug Administration (FDA) has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralisation against.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.
AstraZeneca has completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts).
AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.
Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.