-
AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
•
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…
-
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
•
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…
-
Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
•
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…
-
AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
•
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…
-
AstraZeneca’s Soriot Discusses US BioSecure Act’s Impact Amid China Expansion Plans
•
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…
-
AstraZeneca’s Tralokinumab Trial Data Spurs Development of Brainomix’s e-Lung Software
•
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…
-
Kangtai Biological Partners with AstraZeneca and Beijing Daxing District to Boost Vaccine Market Presence
•
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…
-
Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
•
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…
-
AstraZeneca to Acquire Fusion Pharmaceuticals in a Deal Valued at USD 2.4 Billion
•
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…
-
AstraZeneca’s Lynparza-Imfinzi Combo Shows Promising Results in Endometrial Cancer Study
•
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…
-
AstraZeneca Caps Monthly Costs for US Patients with Asthma and COPD Inhalers
•
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…
-
AstraZeneca Acquires Amolyt Pharma for $800 Million to Bolster Rare Disease Pipeline
•
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…
-
KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
•
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…
-
ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
•
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…
-
EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
•
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…
-
AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
•
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…
-
AstraZeneca’s Fasenra Matches Nucala in EGPA Trial and Shows Steroid Reduction Benefits
•
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…
-
AstraZeneca Expands Global Footprint with Shanghai Strategic Center
•
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…
-
AstraZeneca Launches Phase I Trial for siRNA Therapy in Collaboration with Silence Therapeutics
•
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,…
-
AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
•
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…
