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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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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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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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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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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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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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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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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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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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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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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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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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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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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…
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that the European Commission (EU) has granted another indication approval for its drug Tagrisso (osimertinib). The approval is for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors exhibit epidermal growth factor receptor (EGFR)…
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). The designation is for the use of Orpathys in combination with Tagrisso (osimertinib) for the…
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UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN) has updated data from the Phase III OlympiA study for its PARP inhibitor Lynparza (olaparib) at the San Antonio Breast Cancer Symposium 2024 (SABCS). The study provides significant insights into the efficacy and safety of Lynparza in patients with germline BRCA-mutated (gBRCAm) HER2-negative…
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced that their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA). The designation is based on the positive results from the Phase II…
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that the US Food and Drug Administration (FDA) has accepted for review an additional indication filing for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The filing, which seeks approval for the treatment of muscle-invasive bladder cancer (MIBC), has also been…
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UK-based pharmaceutical company AstraZeneca (AZ, NASDAQ: AZN) has announced positive results from the PACIFIC-5 III study for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The study focused on patients with unresectable stage III non-small cell lung cancer (NSCLC) who did not experience disease progression after receiving synchronous or sequential…