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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…
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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 (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 treating…
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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…
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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…
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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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China Invalidates Heart Failure Patent for Dapagliflozin, Maintains Protection for Kidney Disease Use
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The China National Intellectual Property Administration (CNIPA) has announced a pivotal decision concerning the patent status of Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor co-developed by Bristol-Myers Squibb and AstraZeneca. The patent (ZL202011290859.2) related to heart failure has been completely invalidated, while the chronic kidney disease patent (ZL202210071080.4) remains intact.…
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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…
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AstraZeneca and BenevolentAI Reach Milestone in Heart Failure Target Validation
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AstraZeneca (AZ; NASDAQ: AZN) has announced the successful experimental validation of a groundbreaking heart failure target discovered by BenevolentAI (AMS: BAI), a UK-based precision drug design company. This milestone achievement marks a significant step in their ongoing partnership, which was initially established in 2019 with a focus on idiopathic pulmonary…
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Nabla Bio Forges Partnerships with Top Pharma Companies to Tackle Challenging Drug Targets
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Protein design specialist Nabla Bio has announced strategic collaborations with pharmaceutical giants AstraZeneca (AZ; NASDAQ: AZN), Bristol Myers Squibb (BMS; NYSE: BMY), and Takeda (NYSE: TAK). These partnerships underscore the biotech company’s commitment to leveraging its integrated AI and wet-lab technologies for the design of conformation- and target-selective antibody candidates.…
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BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with unresectable stage III non-small cell lung cancer (NSCLC) did not achieve its primary endpoint of progression-free survival (PFS). The study compared the efficacy and safety of Opdivo…
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AstraZeneca Hong Kong Launches ‘HRDetect’ Program to Offer Free Genetic Testing for Cancer Patients
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AstraZeneca (AZ, NASDAQ: AZN) Hong Kong has announced a partnership with Inocras Hong Kong Ltd and Cancerinformation.com.hk Charity Foundation (CICF) to launch the “HRDetect” program in Hong Kong and Macau. This initiative will provide eligible cancer patients in both regions with complimentary BRCA or HRD genetic testing. The genetic testing…
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U.S. Judge Dismisses Johnson & Johnson and Bristol-Myers Squibb Lawsuits Against Drug-Pricing Provisions in Inflation Reduction Act
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In a recent legal development, a U.S. federal court judge has rejected the legal challenges brought by pharmaceutical giants Johnson & Johnson (J&J; NYSE: JNJ) and Bristol-Myers Squibb (BMS; NYSE: BMY) against the drug-price negotiations outlined in President Joe Biden’s Inflation Reduction Act (IRA). The companies had filed separate lawsuits…
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Daiichi Sankyo Reports 25.3% Revenue Growth in FY2023, Boosted by Enhertu and Lixiana Sales
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Japanese pharmaceutical company Daiichi Sankyo has reported a remarkable fiscal year 2023, with revenues increasing by 25.3% to ¥1.602 trillion (USD 10.05 billion) for the 12-month period ended March 31, 2024. The growth was primarily driven by the success of its HER2-targeted antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) and…
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Kexing Pharmaceutical Secures Global Rights for Qingfeng’s Generic Olaparib
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China’s Kexing Pharmaceutical (SHA: 688136) has secured a global commercialization licensing agreement with Qingfeng Pharmaceutical Group for the latter’s generic version of olaparib. Under this deal, Kexing will obtain commercial rights for the product across an initial batch of 10 international markets. Meanwhile, Qingfeng’s generic formulation is currently awaiting regulatory…
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AbelZeta Pharma’s CAR-T Therapy C-CAR031 Receives Implicit Approval for Clinical Study in China
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Sino-US biotechnology company AbelZeta Pharma Inc., operating in Rockville, Maryland, and Shanghai, China, has received implicit approval for its autologous armored GPC3-targeted chimeric antigen receptor (CAR) T cell therapy, C-CAR031, developed by its subsidiary, Shanghai Cellular Biopharmaceutical Group Ltd. The therapy is intended for the treatment of GPC3+ advanced or…
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AstraZeneca Reports 19% YOY Revenue Growth in Q1 2024, Driven by Oncology and R&I
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has released an impressive set of financial results for the first quarter of 2024, with overall revenues increasing by 19% year-on-year (YOY) in constant currency terms to USD 12.68 billion. Product sales soared 18% YOY, reaching USD 12.18 billion. The company’s business units…
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Zai Lab Ltd Appoints New Greater China CCO as Liang Yi Exits
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced the appointment of Zhu Tong as the new Greater China Chief Commercial Officer (CCO), succeeding Liang Yi, who is departing from his role as both CCO and President of Greater China. Liang’s departure will become official on April 30. Zhu Tong’s…
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Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
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Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase IIa proof-of-concept trial for its anti-thymic stromal lymphopoietin (TSLP) biologic, Tezspire (tezepelumab), in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The trial indicated that Tezspire reduced the annualized rate of moderate or severe exacerbations…
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AstraZeneca’s Imfinzi Shows Sustained Survival Benefit in Advanced Biliary Tract Cancer Trial
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has this week announced 3-year results from a Phase III clinical trial of its anti-PD-L1 therapy Imfinzi (durvalumab) in combination with chemotherapy for the treatment of advanced biliary tract cancer (BTC). The trial, after a median follow-up of 41.3 months,…
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AstraZeneca’s Fasenra Gains FDA Approval for Pediatric Severe Asthma Treatment
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AstraZeneca (AZ; NASDAQ: AZN) has secured an indication extension from the U.S. Food and Drug Administration (FDA) for its anti-eosinophil biologic Fasenra (benralizumab). The drug is now approved as an add-on maintenance treatment for severe asthma in pediatric patients aged 6 to 11 years with an eosinophilic phenotype, expanding its…
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Enhertu Shows 58.3% Response Rate in Phase II Lung Cancer Study, AstraZeneca and Daiichi Sankyo Report
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The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568, OTCMKTS: DSNKY), were unveiled at the American Association for Cancer Research (AACR) 2024 annual meeting. The study reported an objective response rate (ORR) of 58.3% (95% CI:…
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Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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AstraZeneca’s Imfinzi Achieves Positive Results in Late-Stage Trial for Small Cell Lung Cancer
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that a late-stage trial for its anti-PD-L1 drug Imfinzi (durvalumab) has successfully met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC). The trial’s success marks a significant milestone…
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AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
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Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid…
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AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
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Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
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Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has secured regulatory approval from the US Food and Drug Administration (FDA) for its Factor D inhibitor Voydeya (danicopan). The drug is approved as an add-on therapy to ravulizumab or eculizumab, which are marketed as Ultomiris…
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AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
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AstraZeneca’s Soriot Discusses US BioSecure Act’s Impact Amid China Expansion Plans
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Pascal Soriot, CEO of AstraZeneca (NASDAQ: AZN), addressed the potential implications of the US BioSecure Act in an interview with Bloomberg during the Boao Forum for Asia in China this week. Soriot expressed that, should the act pass, “It will not necessarily affect us,” citing the “very segmented” nature of…
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AstraZeneca’s Tralokinumab Trial Data Spurs Development of Brainomix’s e-Lung Software
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AstraZeneca (AZ; NASDAQ: AZN) has reported data from a Phase II trial for its idiopathic pulmonary fibrosis (IPF) candidate, tralokinumab, which has contributed to the development of Brainomix’s e-Lung software. This AI-enabled tool, announced by the UK medtech company this week, is designed to identify patients at risk of decline…
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Kangtai Biological Partners with AstraZeneca and Beijing Daxing District to Boost Vaccine Market Presence
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a prominent biopharmaceutical company based in China, has entered into a strategic agreement with UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) and the Daxing district government of Beijing. The collaboration is focused on the vaccine sector, aiming to introduce new vaccines to the…
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Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
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AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with the US Food and Drug Administration (FDA) for the treatment of anti-AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) in adults. This registration follows an initial rejection by the FDA last year and positions Ultomiris…
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AstraZeneca to Acquire Fusion Pharmaceuticals in a Deal Valued at USD 2.4 Billion
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based pharmaceutical giant, has announced its intention to acquire Fusion Pharmaceuticals (NASDAQ: FUSN), a Canada-based developer of radioconjugate (RC) therapies, in a deal valued at up to USD 2.4 billion, including upfront and potential contingent value payments. The acquisition is expected to be finalized in…
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AstraZeneca’s Lynparza-Imfinzi Combo Shows Promising Results in Endometrial Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has presented interim results from a late-stage study combining the PARP inhibitor Lynparza (olaparib) with the anti-PD-L1 Imfinzi (durvalumab) for the treatment of newly diagnosed advanced or recurrent endometrial cancer. The study has shown promising outcomes, with the combination therapy extending the…
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AstraZeneca Caps Monthly Costs for US Patients with Asthma and COPD Inhalers
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced an expansion of its accessibility program for inhaled respiratory drugs in the US. The initiative will cap monthly expenses at USD 35 for eligible patients suffering from asthma and chronic obstructive pulmonary disease (COPD). The savings program includes coverage…
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AstraZeneca Acquires Amolyt Pharma for $800 Million to Bolster Rare Disease Pipeline
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AstraZeneca (AZ; NASDAQ: AZN) has finalized a definitive agreement to acquire France-based biopharmaceutical company Amolyt Pharma for an upfront payment of $800 million, with an additional potential milestone payment of $250 million. The transaction is anticipated to close by the third quarter of 2024, pending customary regulatory approvals. Amolyt Pharma…
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KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
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Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies. HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS…
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ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
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Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched dapagliflozin, its self-operated product with marketing rights. This drug serves as a generic version of AstraZeneca (NASDAQ: AZN)’s Forxiga, a leading treatment for type 2 diabetes. The approval for dapagliflozin was secured through Nanjing F&S…
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EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
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The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
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AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its drug candidate AZD0486 (TNB-486) in patients with recurrent or refractory B-cell acute lymphoblastic leukemia. AZD0486 is a bispecific antibody (BsAb) that targets both…
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AstraZeneca’s Fasenra Matches Nucala in EGPA Trial and Shows Steroid Reduction Benefits
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has presented results from a Phase III trial that previously announced the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) against GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab), the current standard of care for relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The data revealed…
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AstraZeneca Expands Global Footprint with Shanghai Strategic Center
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AstraZeneca (AZ, NASDAQ: AZN) has declared that Shanghai is now its fifth global strategic center, joining the ranks of Cambridge in the UK, Boston and Gethersburg in the United States, and Gothenburg in Sweden. This move is complemented by AstraZeneca’s plan to collaborate with innovative pharmaceutical companies in Shanghai for…
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AstraZeneca Launches Phase I Trial for siRNA Therapy in Collaboration with Silence Therapeutics
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AstraZeneca (AZ; NASDAQ: AZN) has commenced a Phase I trial for a short interfering RNA (siRNA) therapy targeting an undisclosed disease, marking the first clinical candidate to emerge from its 2020 collaboration with UK-based Silence Therapeutics (NASDAQ: SLN). This partnership aims to develop up to ten siRNA therapeutics across cardiovascular,…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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AstraZeneca Secures Shareholder Approval for $1 Billion Acquisition of Gracell Biotechnologies
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The proposed acquisition of China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) by UK pharmaceuticals giant AstraZeneca (AZ, NASDAQ: AZN) has received approval from Gracell’s shareholders during an extraordinary general meeting held on February 19, 2024. An overwhelming 99.9% of shareholders voted in favor of AstraZeneca’s $1 billion acquisition, with potential total…
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AstraZeneca’s Tagrisso Wins Expanded FDA Approval for EGFR-mutated NSCLC
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has received a new indication approval from the US Food and Drug Administration (FDA) for its lung cancer therapy Tagrisso (osimertinib). The fresh indication allows for the use of Tagrisso in combination with chemotherapy for patients with advanced or metastatic epidermal growth factor…
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AstraZeneca Reports 6% Revenue Growth in 2023, Driven by Oncology and Diabetes Drug Sales
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based multinational, reported its financial results for 2023 this week, revealing a 6% year-on-year increase in annual global revenues, reaching USD 45.8 billion at constant exchange rates. Oncology revenue surged by 21%, while cardiovascular, renal, and metabolism (CVRM) sales rose 18%. Respiratory and immunology (R&I)…
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AstraZeneca Announces $300 Million Investment in Next-Gen Cell Therapies Manufacturing in the U.S.
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has announced a significant investment of $300 million to establish a next-generation cell therapies manufacturing facility in the United States. This new site is set to enhance support for global clinical trials and facilitate local product launches. This strategic move follows AstraZeneca’s…
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AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
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AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
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USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
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In a surprising turn of events in the ongoing intellectual property dispute, the US Patent and Trademark Office (PTO) has invalidated a 2020 patent for conjugation compounds used in antibody-drug conjugates (ADCs), which was held by Pfizer’s (NYSE: PFE) subsidiary Seagen and contested by Japan’s Daiichi Sankyo (TYO: 4568). The…
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AstraZeneca China Announces Leadership Changes and New Biopharmaceutical Unit
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AstraZeneca (AZ, NASDAQ: AZN)’s China unit is set to undergo significant organizational changes, including the establishment of a new business department and three C-suite appointments, as reported by local media. Chen Kangwei, currently the General Manager of AstraZeneca’s China oncology division, will relocate to Singapore for family reasons, taking on…
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Cytokinetics Attracts Big Pharma Interest Amid Aficamten’s Phase III Success
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Cytokinetics (NASDAQ: CYTK), a specialist in cardiovascular diseases, is reportedly attracting interest from multiple Big Pharma companies keen on its promising pipeline in cardiovascular and neuromuscular diseases. Sources indicate that Novartis (NYSE: NVS) was initially leading the charge against competitors AstraZeneca (AZ, NASDAQ: AZN) and Johnson & Johnson (J&J, NYSE:…
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AstraZeneca Secures Exclusive Rights to Omniose’s Enzyme Platform for Bacterial Vaccine Development
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AstraZeneca (AZ; NASDAQ: AZN) has secured an exclusive licensing agreement with biotechnology firm Omniose for up to three years, gaining access to Omniose’s enzyme-based bioconjugation platform. This platform will be utilized for the development of vaccines targeting bacterial pathogens, including those that are multidrug-resistant. Omniose’s proprietary enzyme technology enables the…
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AstraZeneca and Sanofi’s RSV Prevention Drug Beyfortus Approved by China’s NMPA
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AstraZeneca (AZ, NASDAQ: AZN) and Sanofi (NASDAQ: SNY), co-development partners in the pharmaceutical industry, have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their drug Beyfortus (nirsevimab). The antibody is now approved for use in preventing lower respiratory tract infections caused by respiratory…
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Allorion Therapeutics Strikes Deal with AstraZeneca for EGFR L858R Inhibitor Development and Commercialization
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Allorion Therapeutics, a China-based biopharmaceutical company, has announced an exclusive option and global licensing agreement with AstraZeneca (AZ, NASDAQ: AZN) to develop and commercialize a novel allosteric inhibitor targeting the L858R mutation of the epidermal growth factor receptor (EGFR). The drug is intended for the treatment of advanced EGFR mutant…
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AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
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AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for its ligand-conjugated antisense oligonucleotide (LICA) Wainua (eplontersen) as a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN/ATTRv-PN) in adults. Developed in collaboration with Ionis Pharmaceuticals (NASDAQ: IONS),…
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AstraZeneca to Acquire China’s Gracell Biotechnologies in $1.2 Billion Deal
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Pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced its intention to fully acquire Gracell Biotechnologies Inc., (NASDAQ: GRCL), a China-based developer of chimeric antigen receptor (CAR) T cell therapies. This marks the first major merger and acquisition (M&A) deal by a foreign company targeting one of China’s newest generation biotechs.…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Gilead Acquires Pre-Clinical IL-18BP Targeting Antibody Candidate from Compugen in $848 Million Deal
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Gilead (NASDAQ: GILD) has licensed a potential first-in-class IL-18 binding protein (IL-18BP) targeting antibody candidate from cancer immunotherapy developer Compugen (NASDAQ: CGEN), which is currently in the pre-clinical stage. Gilead will assume development responsibilities from Phase II onwards and will pay USD 60 million upfront, with up to USD 788…
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Sanofi Expands Oncology Portfolio with NK Cell Engager In-License from Innate Pharma
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Sanofi (NASDAQ: SNY) has in-licensed a natural killer (NK) cell engager candidate for solid tumors from France-based Innate Pharma (NASDAQ: IPHA), as per an agreement reached in 2022. Sanofi will pay an initial fee of EUR 15 million (USD 16.4 million) and is committed to potential milestone payments of up…
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GSK’s CCO Calls China a Hotbed for Innovative Molecules and Licensing Deals
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In an interview with the Financial Times, Luke Miels, Chief Commercial Officer of UK-based GlaxoSmithKline (GSK; NYSE: GSK), highlighted China as a key source of innovative molecules for licensing agreements. Miels attributes this trend to China’s robust chemistry capabilities and the willingness of local companies to out-license their rights: “You…
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AstraZeneca Acquires Icosavax to Boost Infectious Disease Pipeline with VLP Vaccine Technology
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced the acquisition of US vaccines specialist Icosavax (NASDAQ: ICVX), including its protein virus-like particle (VLP) platform. AstraZeneca will pay approximately USD 800 million upfront for all outstanding shares, plus about USD 300 million in milestone payments. The acquisition is set to…
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Dizal Pharmaceutical Presents Positive Trial Data for Golidocitinib at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd, (SHA: 688192), a spin-off from AstraZeneca (AZ, NASDAQ: AZN) China established in 2017, has presented robust pivotal trial data for its pipeline candidate golidocitinib at the American Society of Hematology (ASH) Annual Meeting. The data was presented in an oral presentation, showcasing the full analysis…
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MSD Halts Phase III Trial of Keytruda Combo in NSCLC After Missing Primary Endpoints
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III trial for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s (AZ; NASDAQ: AZN) co-developed PARP inhibitor Lynparza (olaparib) for metastatic squamous non-small cell lung cancer (NSCLC). The decision follows the trial’s failure to meet…
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AbelZeta and AstraZeneca Team Up for Co-Development of GPC3-Targeted CAR-T Therapy
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AbelZeta Pharma Inc., a Sino-U.S. biotech firm based in Rockville, Maryland, and Shanghai, has announced a co-development agreement with AstraZeneca (AZ, NASDAQ: AZN) for its C-CAR031 chimeric antigen receptor (CAR) T cell therapy. C-CAR031 is an autologous, armored CAR-T therapy specifically targeting GPC3, currently under development for hepatocellular carcinoma (HCC).…
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AstraZeneca Halts Late-Stage Trials for Lokelma in Hyperkalemia Due to Timing and Event Rate Issues
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, has announced the termination of two late-stage trials for its commercial-stage potassium binder, Lokelma (sodium zirconium cyclosilicate), in hyperkalemia (HK) across the cardiorenal spectrum. The company has clarified that the decision is not due to safety concerns and does not affect…
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Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
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Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) for its generic budesonide nasal spray. The product is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis, and for the prevention of nasal…
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AstraZeneca to Open R&D Center in Hong Kong, Focusing on Cell and Gene Therapies
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has concluded a roughly 12-month discussion period with local authorities and is proceeding to establish a research and development (R&D) center in Hong Kong, marking a significant step as it becomes the first leading global Big Pharma to do so in the city.…
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Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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Dizal Pharmaceutical and Wuxi Gaofa Investment to Establish Joint Venture for Auto-Immune Disease Treatments
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China-based AstraZeneca (AZ, NASDAQ: AZN) spin-out, Dizal Pharmaceutical Co., Ltd (SHA: 688192), has entered into a cooperation framework agreement with Wuxi Gaofa Investment Development Group Co., Ltd to establish a joint venture (JV). The JV will focus on the research, development, manufacturing, and sale of golidocitinib and DZD8586, which are…
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AstraZeneca Launches Evinova to Enhance Global Clinical Development with Digital Health Solutions
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UK-based AstraZeneca (AZ; NASDAQ: AZN) has launched Evinova, a digital health solutions provider, with the aim of supporting global clinical development. Evinova offers AI-enabled technologies and services to clinical trial (CT) sponsors, clinical research organizations (CROs), CT site care teams, and patients. The new business unit will initially focus on…
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Usynova Pharmaceuticals Inks Licensing Deal with AstraZeneca for KRASG12D Inhibitor UA022
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Shanghai-based Usynova Pharmaceuticals Ltd has announced a licensing agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) concerning its pipeline candidate, UA022. UA022 is a small-molecule drug targeting the KRASG12D mutation, currently in the pre-clinical stages of development. Terms of the Agreement and FinancialsUnder the agreement, AstraZeneca (AZ) will secure…
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AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
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AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
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The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
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Chiesi Farmaceutici and Shanghai Pharmaceutical Partner on Distribution at CIIE
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Among the series of deals secured by multinational corporations at the 6th China International Import Expo (CIIE), Italy-based Chiesi Farmaceutici S.p.A. has inked a partnership with Shanghai Pharmaceuticals Co., Ltd (SHA: 601607, HKG: 2607). This strategic alliance aims to capitalize on Shanghai Pharmaceutical’s extensive distribution network. As reported by Shine,…
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AstraZeneca Reports Q3 2023 Revenue Growth and Oncology Milestones
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has released its financial results for the third quarter of 2023, showing a total revenue increase of 6% year-on-year (YOY) to USD 11.5 billion in constant currency terms. Product sales accounted for USD 11.02 billion, marking a 5% YOY increase. Excluding COVID-19 medicines,…
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AstraZeneca Expands China Presence with Over 30 Agreements at CIIE
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At the 6th China International Import Expo (CIIE) in Shanghai, UK-based pharmaceutical giant AstraZeneca plc (AZ; NASDAQ: AZN) has signed over 30 agreements with Chinese provincial governments and other entities, marking a significant expansion in China. The agreements include substantial investments and collaborations aimed at enhancing local production, improving access…
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FibroGen Inc. Reports 155% YOY Sales Increase in Q3 2023 Financial Results
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US-based biotechnology company FibroGen Inc., (NASDAQ: FGEN) has reported its financial results for the third quarter of 2023, showcasing a significant year-on-year (YOY) increase in global sales. The company’s revenues rose by 155% to USD 40.1 million, reflecting the success of its anti-anemia drug for chronic kidney disease (CKD), Evrenzo…
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Baheal Pharmaceutical Partners with AstraZeneca for Exclusive Distribution of Losec in China
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China-based health services and distribution giant Baheal Pharmaceutical Group has announced a strategic partnership with AstraZeneca (AZ, NASDAQ: AZN), securing exclusive retail distribution rights for the renowned digestive drug Losec (omeprazole) in mainland China. The financial details of this agreement have not been disclosed. This partnership follows Baheal’s previous acquisition…
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AstraZeneca Announces Positive Phase IIb Results for CKD Treatment Combination
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced last week that its combination therapy of ETA receptor antagonist zibotentan and SGLT2 inhibitor dapagliflozin achieved dose-dependent reductions in urinary albumin-to-creatinine ratio (UACR) during a Phase IIb trial for chronic kidney disease (CKD). This development marks a significant step forward in the…
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AstraZeneca Partners with Cellectis for Next-Generation Cell and Gene Therapies
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced a strategic partnership with Cellectis (EPA: ALCLS; NASDAQ: CLLS) to develop next-generation therapeutics, focusing on areas of high unmet need such as oncology, immunology, and rare diseases. This collaboration aims to leverage Cellectis’s gene editing technologies and manufacturing capabilities to advance…
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AstraZeneca Licenses Nanoform’s Starmap AI Platform to Enhance Drug Development
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has obtained a license from Finnish drug design expert Nanoform Finland (HEL: NANOFH) for Starmap, an innovative AI-enabled platform. This platform facilitates confidential in silico testing of molecule candidates prior to chemical synthesis, aiming to reduce clinical attrition throughout the drug development pipeline.…
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EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
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The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
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AstraZeneca’s Soliris Gains Approval in China for NMOSD Treatment
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has announced that its rare disease drug Soliris (eculizumab) has received marketing approval in China for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. This approval marks a significant expansion of Soliris’s application in the Chinese…
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Ascentage Pharma and AstraZeneca Expand Collaboration on CLL/SLL Treatment
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China’s Ascentage Pharma (HKG: 6855) and UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) have entered into a second clinical collaboration agreement to further study the combination of Ascentage’s Bcl-2 inhibitor lisaftoclax with AZ’s BTK inhibitor acalabrutinib (Calquence). This partnership is specifically aimed at conducting a registrational Phase III trial to…
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AstraZeneca Seeks Approval for Capivasertib in Combination with Faslodex for Breast Cancer Treatment
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AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug candidate, capivasertib, in combination with Faslodex (fulvestrant), according to the China Center for Drug Evaluation (CDE) website. The filing has been accepted for review, marking a significant step forward in the treatment of hormone receptor…
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AstraZeneca Alum Yu Yuping Appointed Vice-President at Merck KGaA’s China Unit
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Yu Yuping, a seasoned professional with a distinguished career at AstraZeneca (AZ, NASDAQ: AZN), has reportedly taken on a new role at German pharmaceutical giant Merck KGaA (ETR: MRK). He has been appointed as the vice-president of Merck’s China medicine and health business, where he will lead the Cardiovascular, Metabolic,…
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AstraZeneca Reports Positive Phase III Results for Forxiga in Children with Type 2 Diabetes
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UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced promising results from the Phase III T2NOW study (NCT03199053) for its diabetes medication, Forxiga (dapagliflozin), in adolescents and children aged 10 to 17 with type 2 diabetes (T2D). Enrolling 256 patients, this study stands as one of the largest investigations into type 2…
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Hong Kong Government Partners with AstraZeneca, Tigermed, and Simcere to Boost Innovation
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The government of the Hong Kong Special Administrative Region has entered into significant partnership agreements with AstraZeneca (AZ, NASDAQ: AZN), Tigermed (SHE: 300347), Simcere (HKG: 2096), and a total of 20 other companies. This initiative is set to generate cumulative investments of HKD 30 billion (approximately USD 3.83 billion) in…
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EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
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AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
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AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
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AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
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UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
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AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
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AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
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AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food and Drug Administration (FDA) for an indication extension of its complement inhibitor Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. The FDA has requested modifications to the drug’s…
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Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
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Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
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AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
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AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an indication extension approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its orphan drug Soliris (eculizumab). The drug is now approved as a treatment for generalized myasthenia gravis (gMG) in pediatric patients who…
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AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
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The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
