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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…
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HHS Releases List of 10 Drugs for Medicare Price Negotiations Starting 2026
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The Department of Health and Human Services (HHS) in the US has released a list of the first 10 medicines that will be subject to a novel mechanism for negotiating drug prices under the Medicare health insurance program starting from the 2026 period onwards. The institution plans to publish the…
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AstraZeneca Challenges US Government’s Drug Price Negotiation Plan for Medicare
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has filed a legal claim against the US government’s plan to negotiate the price of selected drugs for the 2026 period onwards through the elderly health insurance program, Medicare. This move makes AstraZeneca the fourth company to contest the initiative this year, following…
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AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
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Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for the use of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a treatment for BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant…
