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AstraZeneca’s ALXN2350 Selected for CDE’s Rare Disease Drug Development Program
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The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s (AZ, NASDAQ: AZN) ALXN2350 in the patient-centered rare disease drug development pilot program, known as the Care Plan. The public has until December 23 to provide feedback on the notice. ALXN2350: A Potential Treatment for…
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Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
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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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AstraZeneca’s Lynparza Shows Sustained Improvements in OlympiA Phase III Study
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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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AstraZeneca’s Imfinzi Receives FDA Priority Review for Muscle-Invasive Bladder Cancer
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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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AstraZeneca’s Imfinzi Demonstrates Positive Outcomes in PACIFIC-5 III Study for NSCLC
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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…
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AstraZeneca’s Calquence Combo Shows 35% Reduced Risk in CLL: AMPLIFY Phase III Results
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At the 66th American Society of Hematology (ASH) annual meeting, UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) revealed the latest results from the Phase III AMPLIFY study for its drug Calquence (acalabrutinib) in combination with venetoclax for adult patients with chronic lymphocytic leukaemia (CLL). AMPLIFY Study Design and FindingsThe AMPLIFY…
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AstraZeneca’s Imfinzi Receives FDA Approval for Limited-Stage Small Cell Lung Cancer
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has reported receiving a new indication approval from the US Food and Drug Administration (FDA) for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The approval is for the use of Imfinzi in treating adult patients with limited-stage small cell lung cancer (LS-SCLC)…
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AstraZeneca Appoints Iskra Reic as EVP, International, Amid Leon Wang’s Investigation in China
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced the appointment of Iskra Reic, Ph.D., as Executive Vice President (EVP), International. Reic will be responsible for overseeing the overall strategy and driving sustainable growth across key regions including China, Asian and Eurasian markets, the Middle East & Africa,…
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AstraZeneca’s Truqap Meets Primary Endpoint in Phase III Prostate Cancer Study
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UK-based pharmaceutical giant AstraZeneca Inc., (AZ, NASDAQ: AZN) has announced that its Phase III CAPItello-281 study has successfully met its primary endpoint of radiographic progression-free survival (rPFS). The study evaluated the efficacy of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient de novo…
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AstraZeneca’s ALXN1850 (Efzimfotase Alfa) Selected for China’s Rare Disease Care Plan
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The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s (AZ, NASDAQ: AZN) ALXN1850, known as efzimfotase alfa, in the patient-centered rare disease drug development pilot program, referred to as the Care Plan. This move signifies a significant step forward in the global efforts to…
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AstraZeneca’s Tagrisso Receives Positive CHMP Opinion for EGFR-Mutated NSCLC
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for its drug Tagrisso (osimertinib). The EGFR-tyrosine kinase inhibitor (EGFR-TKI) is now recommended for approval to treat adult patients…
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Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks…
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AstraZeneca Inc. Reports 21% YOY Revenue Growth in Q3 2024 Financials
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UK-based pharmaceutical giant AstraZeneca Inc. (AZ, NASDAQ: AZN) has reported its financial performance for the Q3 2024 period, showing a robust 21% year-on-year (YOY) increase in total revenues to USD 13.565 billion at constant exchange rates. Product sales also saw a significant 20% growth to USD 12.947 billion. Business Unit…
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AstraZeneca’s Tezspire Meets Phase III Co-Primary Endpoints in CRSwNP Study
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced positive high-level results from the Phase III WAYPOINT study for Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) co-developed with US firm Amgen (NASDAQ: AMGN),…
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Daiichi Sankyo and Alteogen Sign $300 Million Deal to Develop Subcutaneous Enhertu
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Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has entered into a potentially $300 million agreement with South Korean biotechnology firm Alteogen to develop a subcutaneous injection version of its cancer drug Enhertu, which is also in collaboration with AstraZeneca. This innovative step aims to enhance patient accessibility and…
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AstraZeneca Confirms Executive Vice President Leon Wang’s Detention in China
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has provided an update to investors regarding the status of Leon Wang, Executive Vice President International and AstraZeneca China President. The company has confirmed that Wang is currently “in detention” in China and was last reported to be “cooperating with…
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AstraZeneca’s China President Leon Wang Confirmed to Assist in Investigation Amid Fraud Allegations
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On October 29, 2024, just hours after celebrating a business school anniversary on social media, AstraZeneca’s (AZ, NASDAQ: AZN) Global Executive Vice President and China President, Leon Wang, was confirmed to be cooperating with an investigation. The announcement came less than 48 hours later via AstraZeneca China’s official website. On…
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AstraZeneca China President Leon Wang Involved in Chinese Investigation Amid Industry Probes
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Leon Wang, Executive Vice President International and AstraZeneca (AZ, NASDAQ: AZN) China President, is cooperating with an investigation by Chinese authorities, as stated by the UK pharmaceutical major. During this period, AstraZeneca China General Manager Lai Minglong will ensure business continuity. This development follows a series of media reports about…
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BeiGene CCO Yin Min Detained Amid Investigation; Company Affirms Compliance Standards
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On October 25, Yin Min, Chief Commercial Officer of BeiGene (NASDAQ: BGNE) Greater China, was taken into custody by regulatory authorities for cooperation with an ongoing investigation. Yin Min joined BeiGene in January 2022 after spending 15 years at AstraZeneca (AZ, NASDAQ: AZN), where she held several key positions, including…
