(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
(IN BRIEF) Alexion, a subsidiary of AstraZeneca Rare Disease, is set to present new data at the 9th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple … Read the full press release
Posted in Business, Education, Healthcare, Industrial, Management, Media, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Alexion, Alize Vives, Anna Francis, AQP4, AstraZeneca, Christophe Hotermans, ECTRIMS-ACTRIMS Meeting, effectiveness, Jin Nakahara, Justin Lee, Michael Levy, multiple sclerosis, NMOSD, Rare Neurological Disorder, rituximab, Sami Fam, Soliris, treatment, Ultomiris, Viktoria Papp
Holzkirchen, Germany, 04-May-2018 — /EuropaWire/ — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. Sandoz stands behind … Read the full press release
Posted in Healthcare, Pharma & Biotech, Switzerland
Tagged Biologics Licensing Application, Biosimilar, medicine, Novartis, rituximab, Sandoz, US FDA
Participation in private placement as a cornerstone investor EBRD participates in US$ 51m equivalent private placement of Mabion Mabion is leading biotechnology company in Poland EBRD to invest US$ 18 million (PLN 61.4 million) LONDON, 26-Mar-2018 — /EuropaWire/ — The EBRD … Read the full press release
Posted in Banks, Chemicals, Financial, Investment, Poland, Science, Technology, United Kingdom
Tagged Biosimilar, biotechnology, EBRD, investment, Mabion S.A., multiple sclerosis, Private Placement, rituximab
LONDON, 22-Mar-2018 — /EuropaWire/ — GSK today announced the start of a phase III study investigating Benlysta (belimumab) in combination with rituximab in adult patients with systemic lupus erythematosus (SLE). Belimumab and rituximab have different but potentially complementary mechanisms of action. … Read the full press release
Posted in Healthcare, Pharma & Biotech, United Kingdom
Tagged belimumab, Gijs van den Brink, GSK, lupus, rituximab, SLE, systemic lupus erythematosus
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