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AstraZeneca’s Imfinzi Approved by NMPA for Early-Stage NSCLC Treatment
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UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for a new indication for its PD-L1 inhibitor Imfinzi (durvalumab). The approval allows Imfinzi to be used in combination with chemotherapy for adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC), specifically for patients without…
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AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
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Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the Phase III DESTINY-Gastric04 study for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody drug conjugate (ADC) has demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) in patients with second-line…
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AstraZeneca and Amgen’s Tezspire Shows Positive Results in Phase III Study
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AstraZeneca (NASDAQ: AZN) and Amgen (NASDAQ: AMGN) have jointly announced positive results from the Phase III WAYPOINT study for their co-developed drug Tezspire (tezepelumab). Tezspire is a thymic stromal lymphopoietin (TSLP) – targeted monoclonal antibody (mAb) that has been approved for severe asthma in over 60 countries worldwide. Study ResultsThe…
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AstraZeneca’s Camizestrant Shows Promise in SERENA-6 Breast Cancer Study
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) announced positive interim analysis results from the Phase III SERENA-6 study for its camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Study Details and ResultsThe study evaluated switching to camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor…
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FibroGen to Sell China Subsidiary to AstraZeneca for ~$160M, Roxadustat Rights Included
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US-based biopharma FibroGen Inc. (NASDAQ: FGEN) has entered into an agreement to sell its China subsidiary to UK-based AstraZeneca (NASDAQ: AZN) for approximately USD160 million. The deal includes the transfer of all rights to roxadustat, a treatment for anemia caused by chronic kidney disease (CKD), in China. Transaction DetailsUnder the…
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AstraZeneca Faces Class Action Lawsuits Over China Legal Issues
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AstraZeneca plc (AZ, NASDAQ: AZN) is facing multiple class action lawsuits in the United States related to recent legal issues in China, including the arrest of its former China market president, Leon Wang. The lawsuits allege that the UK-based pharmaceutical giant made misleading statements about its operations in China, failing…
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AstraZeneca’s 2024 Financials Beat Expectations with 21% Revenue Growth
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) reported total revenues of USD 54.07 billion in its 2024 financial report, marking a 21% year-on-year (YOY) increase in constant exchange rate terms. Product sales reached USD 50.98 billion, up 19% YOY, with Q4 product sales climbing 19% to USD 13.36 billion. The…
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FDA Approves Enhertu for HER2-Low and HER2-UltraLow Breast Cancer
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The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow…
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Pfizer Reports 7% Revenue Growth in 2024, Expects Steady Performance in 2025
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US major Pfizer Inc. (NYSE: PFE) has released its financial results for the fourth quarter and full year of 2024. The company recorded revenues of $63.627 billion for the full year, up 7% year-on-year (YOY) in constant currency terms. Excluding COVID-19 products Paxlovid and Comirnaty, revenues grew by 12%. During…
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Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received FDA approval for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultra-low (IHC 0 with membrane staining) breast…
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FDA Approves AstraZeneca’s Calquence for Mantle Cell Lymphoma
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UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) last week revealed that the US Food and Drug Administration (FDA) has approved its BTK inhibitor Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic…
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FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
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Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (AZ, NASDAQ: AZN), last week received approval from the US FDA for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor…
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MediLink Therapeutics and AstraZeneca Collaborate on YL201 and Imfinzi Combo for Solid Tumors
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Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced a clinical cooperation agreement with UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN). The collaboration aims to explore the potential of combining MediLink’s YL201 with AstraZeneca’s Imfinzi (durvalumab) in the treatment of multiple solid tumors. Upcoming Phase I/Ib StudyA multi-center, open…
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Samsung Bioepis and Teva Partner on Biosimilar EPYLLI for US Market
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South Korea’s Samsung Bioepis and Israel-based Teva Pharmaceutical (NYSE: TEVA) have entered into a license, development, and commercialization agreement focused on Samsung Bioepis’s EPYLLI, a biosimilar competing with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab) on the US market. Under the partnership, Samsung Bio will be responsible for the development, regulatory…
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AstraZeneca’s Tagrisso Receives NMPA Approval for EGFR-Mutated NSCLC Treatment
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UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received a new indication approval from China’s National Medical Products Administration (NMPA) for its non-small cell lung cancer (NSCLC) treatment, Tagrisso (osimertinib). This approval is for the use of Tagrisso in treating adult patients with locally advanced, unresectable NSCLC, whose…
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NMPA Approves Lynparza as Adjuvant Treatment for High-Risk Breast Cancer Patients
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The National Medical Products Administration (NMPA) in China has granted AstraZeneca (AZ, NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for their drug Lynparza (olaparib). The approval is for adjuvant treatment in adult patients with early high-risk breast cancer who have undergone neoadjuvant or adjuvant…
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Daiichi Sankyo’s Datroway Approved in Japan for HR+, HER2- Breast Cancer
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Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer,…
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Daiichi Sankyo and AstraZeneca Withdraw EU Application for Datopotamab Deruxtecan in Lung Cancer
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced the voluntary withdrawal of the marketing authorization application (MAA) in the European Union for their co-developed drug, datopotamab deruxtecan (Dato-DXd). This decision pertains to the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell…
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AstraZeneca China Announces Structural Adjustments to Oncology Business Divisions
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UK major AstraZeneca’s (AZ, NASDAQ: AZN) China unit has announced a new round of structural adjustments, effective January 1, 2025. The oncology business will be reorganized into four distinct divisions: the lung cancer business division, the urogynecology and digestive cancer business division, the breast cancer business division, and the blood…
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Achilles Therapeutics and AstraZeneca Seal $12 Billion Deal for TRACERx NSCLC Study Data
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UK-based Achilles Therapeutics plc has announced a landmark deal worth USD 12 billion with AstraZeneca (AZ, NASDAQ: AZN), which involves the transfer of the UK company’s commercial license of data and samples from the TRACERx Non-Small Cell Lung Cancer (NSCLC) study. TRACERx Study: A Pioneering Effort in Tumor Evolution ResearchThe…
