AstraZeneca

2 Mars 2023 15:00

Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer

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).

24 Februari 2023 15:07

Acquisition of CinCor Pharma complete

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.

24 Februari 2023 15:02

Enhertu approved in China for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens

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.

23 Februari 2023 08:01

AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate

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.

22 Februari 2023 08:07

Calquence tablet formulation approved in the EU for patients with chronic lymphocytic leukaemia

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).

22 Februari 2023 08:02

Imfinzi plus Imjudo approved in the EU for patients with advanced liver and non-small cell lung cancers

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.

21 Februari 2023 08:04

ReSViNet 2023 data reinforce AstraZeneca’s commitment to help prevent Respiratory Syncytial Virus in infants

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.

16 Februari 2023 16:01

AstraZeneca and MSD present final results of key secondary overall survival endpoint from Phase III PROpel trial at ASCO GU Cancers Symposium

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.

9 Februari 2023 08:03

Astrazenecas resultatrapport för helåret och fjärde kvartalet 2022

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

7 Februari 2023 08:02

Forxiga approved in the EU for the treatment of symptomatic chronic heart failure

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).

2 Februari 2023 15:01

Tezspire approved for self-administration in the US with a new pre-filled pen

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.

26 Januari 2023 19:17

Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld

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.

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