AstraZeneca’s Alexion has exercised its option to acquire all remaining equity in Caelum Biosciences for CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis. AL amyloidosis is a rare disease in which misfolded amyloid proteins build up in organs throughout the body, including...
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Cambridge, England – AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi has been approved for patients with mismatch repair proficient (pMMR)...
WILMINGTON, Del. — Updated exploratory results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit at three years for patients with advanced biliary tract cancer (BTC). These results from TOPAZ-1, which are the longest survival...
WILMINGTON, Del. — Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed...
WILMINGTON, Del. – Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration of AstraZeneca’s SAPHNELO® (anifrolumab) demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo.1 The safety...
Cambridge, England – AstraZeneca on Monday released high-level results from the Phase III LAURA study, demonstrating clinical benefit for Tagrisso (osimertinib) as a maintenance treatment for patients with unresectable, stage III, EGFR-mutated non-small cell lung cancer. The pharma did not reveal specific data in its announcement but said that Tagrisso...
BOSTON, Mass. — Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today announced positive initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 clinical trial evaluating STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. Initial results demonstrate...
BOSTON, Mass. — Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of navenibart in people living with hereditary angioedema (HAE). “The initiation of ORBIT-EXPANSE marks exciting progress in the development of...
AUSTIN, Texas — Natera, Inc., a global leader in cell-free DNA testing, presented new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the American Society of Clinical Oncology’s 2024 Gastrointestinal Cancers Symposium (ASCO GI), that took place January 18 – 20, 2024 in San Francisco,...
STOCKHOLM — Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced data presentations highlighting additional analyses from the Phase 3 NefIgArd study with Nefecon in adults with primary IgA nephropathy (IgAN), as well as pre-clinical data on the treatment of Alport syndrome with setanaxib, a novel NOX inhibitor,...