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AstraZeneca’s Fasenra Approved by EU for Eosinophilic Granulomatosis Treatment
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UK pharmaceutical giant AstraZeneca Inc. (NASDAQ: AZN) has received marketing approval from the European Commission for its drug Fasenra (benralizumab) as an additional treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The approval follows the successful outcomes of the MANDARA Phase III trial, marking…
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AstraZeneca’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be…
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Eccogene Inc. Secures $60 Million Milestone Payment from AstraZeneca for ECC5004/AZD5004
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Sino-US firm Eccogene Inc. announced on October 23rd that it is set to receive a $60 million payment from AstraZeneca (AZ, NASDAQ: AZN) following the successful achievement of development milestones for ECC5004/AZD5004, including the dosing of the first patient in the Phase 2b trial. This payment is a part of…
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AstraZeneca’s Saphnelo Approved for Use in Guangdong Under ‘Hong Kong-Macau Drug Access’ Policy
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that its drug Saphnelo (anifrolumab) has been approved by the Guangdong Medical Products Administration (MPA) bureau to be included in medical institutions as part of the “Hong Kong-Macau Drug and Device Access” policy. This policy, within the Greater Bay…
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AstraZeneca Files for Market Approval of Tremelimumab in China for Hepatocellular Carcinoma
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The Center for Drug Evaluation (CDE) has indicated on its website that AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has submitted a market filing for tremelimumab, which is likely intended for the treatment of hepatocellular carcinoma (HCC) in combination with durvalumab. This move suggests a strategic expansion in AstraZeneca’s…
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Thermo Fisher Faces FDA Scrutiny Over Syringe Air Bubble Protocols at North Carolina Plant
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Thermo Fisher Scientific’s (NYSE: TMO) Greenville, North Carolina, facility has come under scrutiny after a US Food and Drug Administration (FDA) inspection revealed certain production procedure issues, including the monitoring and measurement of air bubbles within syringes, according to a Form 483 document obtained by Reuters. The inspection was part…
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Eli Lilly China Appoints Yan Qiong as Vice President of Diabetes Business Unit
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Effective October 10, 2024, Yan Qiong will join the management team of Eli Lilly (NYSE: LLY) China as the vice president of the diabetes products business unit. She will report directly to Huzur Devletsah, the president and general manager of Lilly China. Yan Qiong brings nearly two decades of experience…
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AstraZeneca Strikes Exclusive Licensing Deal with CSPC Pharma for Oral Lp(a) Disruptor
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced the signing of an exclusive license agreement with China-based CSPC Pharmaceutical Group Ltd (HKEX: 01093). The deal grants AstraZeneca the rights to develop YS2302018, a preclinical stage oral Lp(a) disruptor intended for lipid-lowering therapy to treat various cardiovascular disease (CVD)…
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AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
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AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
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AstraZeneca Launches South Korea Innovation Program with Focus on Chinese Market Expansion
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AstraZeneca plc (LON: AZN, Nasdaq: AZN), a UK-based pharmaceutical and biopharmaceutical company, is reportedly launching an innovation program in South Korea aimed at fostering innovative collaborations and facilitating entry into the Chinese market. The company is currently accepting applications for the program until October 11, with the AZ K-Bio Expressway…
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AstraZeneca’s HIMALAYA Trial Data Showcases Significant Survival Benefits for Liver Cancer Treatment at ESMO 2024
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At the European Society for Medical Oncology (ESMO) 2024 conference, AstraZeneca (NASDAQ: AZN, LON: AZN) presented updated data from the HIMALAYA Phase III trial, demonstrating sustained and clinically meaningful overall survival (OS) benefits for patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy and for whom…
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AstraZeneca’s Fasenra Secures FDA Nod for EGPA Treatment, Strengthening Rare Disease Portfolio
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its interleukin-5 (IL-5)-targeted antibody, Fasenra (benralizumab), for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal disease. The approval comes on the…
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AstraZeneca’s Tagrisso Achieves Milestones in Phase III LAURA Study for EGFR-mutated NSCLC at ESMO 2024
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Global pharmaceutical company AstraZeneca (AZ, NASDAQ: AZN, LON: AZN) has reported updated results from the Phase III LAURA study on its EGFR-tyrosine kinase inhibitor (EGFR-TKI), Tagrisso (osimertinib), at the 2024 European Society of Medical Oncology (ESMO) Congress. The study included data from the Chinese cohort, highlighting the drug’s efficacy in…
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AstraZeneca’s Imfinzi-Imjudo Combo Sets New Longevity Benchmark in Liver Cancer Treatment
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has achieved a significant milestone with its drug combination of Imfinzi (durvalumab) and Imjudo (tremelimumab), used in the treatment of patients with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC). Data from the Phase III HIMALAYA trial, showcased at the 2024 European…
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AstraZeneca and Daiichi Sankyo’s Dato-DXd Misses Overall Survival Endpoint but Shows Promise in NSCLC Subgroup
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AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
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AstraZeneca Faces Investigation in China Over Data Privacy and Unapproved Drugs
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, is reportedly under the spotlight in Shenzhen, China, with an investigation involving five current and former employees, as per a report by Bloomberg. The probe is said to center on potential breaches of data privacy regulations and the unauthorized importation of drugs…
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AstraZeneca China Restructures Biopharma Unit to Boost Chronic Disease Management
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AstraZeneca (NASDAQ: AZN)’s Chinese subsidiary has announced a strategic restructuring of its China biopharmaceutical business unit (BBU), with Lin Xiao, currently the general manager of AstraZeneca China’s biopharmaceutical operations and head of the Hong Kong and Macau Region, being appointed to lead the division. The restructuring entails the integration of…
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AstraZeneca Boosts Investment in Qingdao Aerosol Production Hub to $750 Million
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QINGDAO—AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced a further investment in its Qingdao National High-tech Industrial Development Zone facility, dedicated to the production and supply of inhalation aerosols. The undisclosed additional funding follows an initial investment made in March 2023, bringing the total commitment to USD 750…
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AstraZeneca to Invest $135 Million in Swedish Biomanufacturing Facility Expansion
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AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based biopharmaceutical leader, has announced a plan to invest $135 million in its biopharmaceutical manufacturing facility in Södertälje, Sweden. This marks the first significant investment in the Sweden Biomanufacturing Center since its inauguration in 2021. The funding will facilitate a 2,700 square meter…
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AstraZeneca’s Strensiq Approved for Rare Disease Therapy under Greater Bay Area’s Drug Access Policy
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AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK pharmaceutical company, has received approval for its rare disease therapy Strensiq (asfotase alfa) from the Guangdong Medical Products Administration (MPA) bureau. This clearance allows Strensiq to be introduced to medical institutions under the “Hong Kong-Macau Drug and Device Access” policy, a…
