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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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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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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 (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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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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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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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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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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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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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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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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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…
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) is taking strategic steps to capitalize on the opportunities in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) by adjusting its team structure and changing personnel. New Divisional Leadership for GBA ExpansionAstraZeneca will split its respiratory, digestive, and autoimmune business unit into two distinct…
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Scott-Moncrieff & Associates, a UK-based law firm, has disclosed that it is preparing nearly 50 cases against pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) in relation to its SARS-CoV-2 vaccine. The move follows the filing of a product liability claim by a plaintiff earlier this month, who alleged that his wife’s…
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced evidence that its SGLT2 inhibitor, Forxiga (dapagliflozin), provides significant clinical benefits in patients with heart failure (HF) with preserved ejection fraction (pEF) and chronic obstructive pulmonary disease (COPD). This announcement highlights the potential of Forxiga in treating these conditions and underscores…
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UK-based pharmaceutical major AstraZeneca plc (AZ, NASDAQ: AZN) has announced that China’s National Medical Products Administration (NMPA) has granted a new indication approval for its SGLT-2 inhibitor, Forxiga (dapagliflozin). The drug is now approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits…
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has announced a new cooperation agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN), focusing on the development of a companion diagnostic (CDx). This collaboration builds upon a global strategic master collaboration agreement that was first signed at the end of 2021.…
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) is set to invest an additional USD 250 million to establish an inhalation aerosol production and supply plant in Qingdao, China. This significant investment follows an earlier cooperation agreement signed in March 2023 between AstraZeneca and the Qingdao city government, which initially focused…
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Guangzhou-based medical device giant Burning Rock (NASDAQ: BNR) has announced a strategic partnership with AstraZeneca (AZ, NASDAQ: AZN). The collaboration will utilize Burning Rock’s world-leading testing technology and high-quality, standardized testing capacities to develop and commercialize companion diagnostics (CDx) products for AstraZeneca’s breast cancer and prostate cancer therapies. Financial details…
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China-based vaccines specialist CanSino Biologics Inc., (HKG: 6185) has announced a product supply cooperation framework agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN). The agreement entails providing contract development and manufacturing services for AstraZeneca’s mRNA vaccine, with no financial details disclosed. Focus on mRNA Production Platform and Vaccine R&DThis…