London – Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia (CLL). For the secondary …
London – AstraZeneca announced the successful completion of the acquisition of Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The acquisition bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of …
London – AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations. The approval by the European Commission follows the positive opinion of the Committee …
London – Positive results from the LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations, after chemoradiotherapy (CRT) compared to placebo after CRT. …
Washington – AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, 31 May to 4 June 2024. More than 100 abstracts will feature 25 approved and potential new medicines across the Company’s diverse oncology portfolio and pipeline, including two late-breaking plenary presentations, …
London – AstraZeneca intends to build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are next-generation treatments that deliver highly potent cancer-killing agents directly to cancer cells through a targeted antibody. The planned greenfield facility, supported by the Singapore Economic Development Board (EDB), will be AstraZeneca’s first end-to-end …
London – According to The Telegraph, amid “rare and dangerous side effect” of its COVID-19 vaccine, UK-based pharmaceutical manufacturer AstraZeneca has announced withdrawal of its inoculation jab. It will also be withdraw Vaxzevria’s marketing authorisations within Europe. The firm’s application to withdraw the vaccine was made on March 5 and came into effect on May 7.
London – Updated exploratory results from the TOPAZ-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit at three years for patients with advanced biliary tract cancer (BTC). These results from TOPAZ-1, which are the longest survival follow-up ever reported for a global, randomised Phase III trial in this …
London – A new modelling analysis by AstraZeneca, IMPACT CKD, forecasts up to 16.5% of the population across eight countries will suffer from chronic kidney disease (CKD) by 2032, including a rise of up to 59.3% in advanced-stage.1 Presented at the 2024 ISN World Congress of Nephrology (WCN’24) in Buenos Aires, the study highlights an urgent and growing global health crisis …
London – AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for its …
