(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged ASH 2024, autologous stem cell transplant, bortezomib, CHMP, dexamethasone, European Medicines Agency, GMMG-HD7, isatuximab, Journal of Clinical Oncology, lenalidomide, MRD negativity, Multiple Myeloma, NDMM, phase 3 study, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, BTK inhibitor, Calquence, chemoimmunotherapy, chronic lymphocytic leukaemia, clinical trial, CLL, Dave Fredrickson, European Commission approval, European Union, fixed-duration regimen, hematologic diseases, hematology, leukemia, obinutuzumab, oncology, progression-free survival, treatment option, venetoclax
(IN BRIEF) Novartis has announced that its Phase III PSMAddition trial of Pluvicto™ in combination with standard of care (SoC) has met its primary endpoint, showing a significant benefit in radiographic progression-free survival (rPFS) and a positive trend in overall … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged androgen receptor pathway inhibitors, cancer research, clinical trials, FDA approval, FDA regulatory review, metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, mHSPC, Novartis, Novartis oncology, overall survival, Phase III PSMAddition, Pluvicto, progression-free survival, prostate cancer, prostate cancer treatment, PSMA-positive, radioligand therapy, treatment options
(IN BRIEF) GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma. The approval follows positive results from the DREAMM-7 and DREAMM-8 phase III trials, … Read the full press release
Posted in Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anti-BCMA, antibody-drug conjugate, Blenrep, bortezomib, chemotherapy, clinical efficacy, clinical trials, DREAMM-7, DREAMM-8, global markets, GSK, Japan approval, Multiple Myeloma, oncology, orphan drug designation, overall survival, partnership, PDUFA, pomalidomide, progression-free survival, regulatory approval, sustainability, treatment options
(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy to treat limited-stage small cell lung cancer (LS-SCLC) in patients whose disease … Read the full press release
Posted in Business, European Union, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged ADRIATIC Phase III trial, AstraZeneca, CHMP, disease progression, durvalumab, EMA, European Medicines Agency, hazard ratio, Imfinzi, immunotherapy, limited-stage small cell lung cancer, LS-SCLC, monotherapy, overall survival, platinum-based chemoradiation therapy, progression-free survival, regulatory review, safety profile, Small cell lung cancer, Suresh Senan, survival outcomes, Susan Galbraith, The New England Journal of Medicine, treatment approval
(IN BRIEF) AstraZeneca’s Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged acalabrutinib, AstraZeneca, autologous hematopoietic stem cell transplantation, bendamustine, blood cancers, Bruton’s tyrosine kinase, BTK inhibitor, Calquence, chemoimmunotherapy, COVID-19, Dave Fredrickson, ECHO Phase III trial, FDA, global regulatory review, international markets, Lymphoma Research Foundation, mantle cell lymphoma, MCL, Meghan Gutierrez, Michael Wang, oncology, PFS, progression-free survival, Project Orbis, regulatory submission, rituximab, safety profile, U.S. approval
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