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AstraZeneca’s Strensiq Gains Approval for Rare Disease Therapy in Guangdong Under “Hong Kong-Macau Drug and Device Access”
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LONDON—AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK-based pharmaceutical company, has announced that its rare disease therapy Strensiq (asfotase alfa) has been granted market access by the Guangdong Medical Products Administration (MPA) bureau. This approval is a significant step under the “Hong Kong-Macau Drug and Device Access” policy, which…
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AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
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BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ: AZN, LON: AZN) ‘s Fasenra (benralizumab) as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above. This decision follows the positive outcomes of the MIRACLE Phase III clinical…
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AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer
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AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB,…
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Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
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NICE and AstraZeneca Fail to Reach Agreement on Enhertu Reimbursement for NHS
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The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
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AstraZeneca Charts Comprehensive Anti-Obesity Strategy with GLP-1 and Amylin Therapies
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has outlined its strategic advancements and future roadmap in the anti-obesity sector during its Q2 2024 earnings conference call. The company’s foray into this domain was initiated through a partnership with Amylin Pharmaceuticals, which AZ joined by acquiring it for $3.5 billion…
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AstraZeneca’s Q2 2024 Results Highlight Strong Growth Across Therapies, Excluding Vaccines
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AstraZeneca (NASDAQ: AZN), a UK-based biopharmaceutical company, has reported its financial results for the second quarter and the first half of 2024, demonstrating robust growth. For the six-month period, total revenues increased by 18% year-on-year (YOY) to $25.617 billion, with product sales also experiencing an 18% rise to $24.629 billion.…
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Pinetree Therapeutics Strikes EGFR Degrader Deal with AstraZeneca Worth Over USD 500 Million
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Pinetree Therapeutics Inc., a Massachusetts-based biotechnology company, has announced the signing of an exclusive option and global licensing agreement with UK pharmaceutical giant AstraZeneca (NASDAQ: AZN). The deal focuses on a preclinical epidermal growth factor receptor (EGFR) degrader candidate. According to the agreement, Pinetree will receive an initial payment of…
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AstraZeneca’s Voydeya Receives South Korean Approval for PNH Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has reportedly secured market approval in South Korea for its drug Voydeya (danicopan), the world’s first-in-class oral D-factor inhibitor. The Ministry of Food and Drug Safety (MFDS) in Korea approved Voydeya for use as an adjunct therapy for extravascular hemolysis (EVH) in…
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AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
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AstraZeneca’s Gracell Biotechnologies to Expand Cell Therapy Manufacturing in China
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Gracell Biotechnologies, a China-based cell therapy specialist owned by AstraZeneca (AZ; NASDAQ: AZN), is reportedly planning to expand its manufacturing capacity at its Suzhou BioBay life science cluster base, according to a report from Yicai Global. The construction of a 9,000 sq. m. expansion at the site is set to…
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AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
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AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase III clinical trial for its first-in-class adenosine triphosphate (ATP)-competitive AKT inhibitor, Truqap (capivasertib). The trial, known as CAPItelo-290, failed to meet its dual primary endpoints of improved overall survival (OS) in both the overall trial…
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AstraZeneca Restructures County Oncology Team to Enhance Vertical Alignment
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AstraZeneca (AZ, NASDAQ: AZN), a leading global biopharmaceutical company, is planning to restructure and spin off its county oncology team. The team will be integrated into two divisions: the lung cancer division and the urology, gynecology, and women’s oncology division. This strategic move aims to establish a more direct and…
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AstraZeneca’s Farxiga Receives FDA Approval for Pediatric Type-2 Diabetes Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ: AZN) for its SGLT2 inhibitor, Farxiga (dapagliflozin), expanding its use to pediatric patients aged 10 and above with type-2 diabetes (T2D). This approval supplements the drug’s original indication for adult patients. The FDA’s decision was…
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AbelZeta and AstraZeneca’s C-CAR031 Shows Promising Results in HCC Treatment
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AbelZeta, a Sino-US biotech company with operations in Rockville, Maryland, and Shanghai, has presented data for its armored autologous GPC3-targeted chimeric antigen receptor (CAR) T cell therapy candidate, C-CAR031, at the American Society of Clinical Oncology (ASCO) annual meeting. The CAR-T therapy, co-developed with AstraZeneca (NASDAQ: AZN), is currently in…
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AstraZeneca’s Tagrisso Achieves Milestone Progression-Free Survival in Late-Stage Lung Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
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Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the US Food and Drug Administration (FDA) for Bkemv, marking a significant milestone as the first biosimilar in the US to compete with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab). Both the originator drug from AstraZeneca and…
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AstraZeneca Sets Sights on $80 Billion Revenue Target and 20 New Molecular Entities by 2030
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At its recent investor day, AstraZeneca plc (NASDAQ: AZN), a prominent UK pharmaceutical company, articulated its long-term objectives to shareholders. The company outlined an ambitious plan to achieve revenues of $80 billion by 2030, which is nearly double the $45.8 billion reported in 2023. This target will be pursued by…
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AstraZeneca Commits $1.5 Billion to Build Singapore-Based ADC Manufacturing Facility
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced plans for a $1.5 billion greenfield investment to establish a manufacturing presence in Singapore with the construction of a state-of-the-art antibody-drug conjugate (ADC) production site. This facility will be the company’s first end-to-end manufacturing hub, handling all stages of ADC production,…
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Pharmaron and AstraZeneca Enter Sweeping Partnership to Span Drug Development Services
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Pharmaron Beijing Co., Ltd, a leading Contract Research Organization (CRO) based in Beijing (HKG: 3759; SHE: 300759), has announced a comprehensive strategic partnership with the UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN). This collaboration will encompass the entire spectrum of drug development, including small molecules, macromolecules, and gene therapies, from…
