AstraZeneca

(IN BRIEF) Voydeya (danicopan), a first-in-class oral Factor D inhibitor, has been recommended for marketing authorization in the European Union (EU) as an add-on to ravulizumab or eculizumab for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience residual haemolytic … Read the full press release →

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the FDA for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in patients who have undergone prior … Read the full press release →

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) demonstrates significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) in the LAURA Phase III trial. The trial, led by Dr. Suresh Ramalingam, … Read the full press release →

(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release →

(IN BRIEF) In a Phase III trial conducted in Japan, acoramidis, an investigational treatment for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), demonstrated promising high-level results consistent with the global BridgeBio Pharma, Inc. ATTRibute-CM Phase III trial. The trial in Japan aimed to … Read the full press release →

(IN BRIEF) The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Voydeya (danicopan), a groundbreaking oral Factor D inhibitor, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Voydeya is indicated in Japan for use in combination … Read the full press release →

(IN BRIEF) AstraZeneca has announced its definitive agreement to acquire Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases. This strategic move aims to bolster AstraZeneca’s presence in the field of … Read the full press release →

(IN BRIEF) AstraZeneca is set to unveil promising data at the 65th American Society of Hematology (ASH) Annual Meeting, highlighting its expanding hematology pipeline and the enduring effectiveness of Calquence in treating chronic lymphocytic leukemia (CLL). The presentation includes six-year … Read the full press release →

(IN BRIEF) AstraZeneca has introduced Evinova, a groundbreaking venture poised to become a leader in digital health solutions, catering to the needs of healthcare professionals, regulators, and patients. Backed by AstraZeneca and strategically collaborating with Parexel and Fortrea, Evinova is … Read the full press release →

(IN BRIEF) AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has gained approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer possessing specific … Read the full press release →

(IN BRIEF) AstraZeneca has reported positive high-level results from the EMERALD-1 Phase III trial, demonstrating that its drug Imfinzi (durvalumab), in combination with transarterial chemoembolisation (TACE) and bevacizumab, significantly improves progression-free survival (PFS) in patients with hepatocellular carcinoma (HCC) eligible … Read the full press release →

(IN BRIEF) AstraZeneca and Eccogene have signed an exclusive license agreement for ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) designed for the treatment of obesity, type-2 diabetes, and other cardiometabolic conditions. Initial results from the Phase … Read the full press release →

(IN BRIEF) AstraZeneca has entered into a collaboration and investment agreement with biotech firm Cellectis to fast-track the development of cutting-edge therapeutics in areas such as oncology, immunology, and rare diseases. This partnership will leverage Cellectis’ gene editing technologies and … Read the full press release →

(IN BRIEF) Researchers at the University of Leicester have developed a groundbreaking treatment for severe asthma using the monoclonal antibody tezepelumab. This monthly injection targets thymic stromal lymphopoietin (TSLP), a substance associated with inflammation in the airways of severe asthma … Read the full press release →

(IN BRIEF) AstraZeneca’s Supplemental Biologics License Application (sBLA) seeking approval for a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray flu vaccine, has been accepted for review by the US Food and Drug Administration (FDA). If approved, … Read the full press release →

(IN BRIEF) AstraZeneca and Daiichi Sankyo have received European Union (EU) approval for their drug Enhertu as a monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in adult patients with activating HER2 mutations who require systemic therapy … Read the full press release →

(IN BRIEF) Soliris (eculizumab) has received approval in China for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). This makes Soliris the first and only complement inhibitor approved for NMOSD … Read the full press release →

(IN BRIEF) AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) in combination with chemotherapy has been granted Priority Review by the US Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic epidermal … Read the full press release →

(IN BRIEF) AstraZeneca has revealed the eight winners of its 2023 R&D Postdoctoral Challenge, an initiative that supports early-career scientists in pursuing their innovative research proposals. Unlike traditional industry postdoctoral programs, this unique challenge allows researchers from around the world … Read the full press release →

(IN BRIEF) AstraZeneca is set to present new data at the 12th annual IDWeek conference, emphasizing the role of long-acting antibodies and vaccines in safeguarding at-risk individuals from common infectious respiratory diseases. The company will share 15 abstracts, including oral … Read the full press release →