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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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Sanofi’s RSV Preventative Therapy Beyfortus Launches in China
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has announced the commercial launch of Beyfortus (nirsevimab), a preventative therapy for Respiratory Syncytial Virus (RSV), in China. Nirsevimab, a long-acting monoclonal antibody (mAb), is the first and only RSV preventative therapy in China that covers a wide range of infants, including…
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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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CSPC Pharmaceutical Secures NMPA Nod for Generic Version of AstraZeneca’s Lynparza
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…
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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 Partners with Nona Biosciences in Multimillion-Dollar Monoclonal Antibody Agreement
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HBM Holdings Ltd’s (HKG: 2142) wholly-owned subsidiary, Nona Biosciences, has announced a significant licensing agreement with the UK pharmaceutical giant AstraZeneca. The deal revolves around a pre-clinical monoclonal antibody (mAb) program, marking a substantial step forward in the development of innovative therapies. Under the terms of the agreement, AstraZeneca will…
