(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and … Read the full press release
Posted in Business, Germany, Healthcare, Pharma & Biotech
Tagged #FutureFresenius, Actemra®, autoimmune diseases, Biosimilar, Cancer, cancer treatment, FDA, Food and Drug Administration, Fresenius Kabi, Genentech, Idacio®, inflammatory, inflammatory diseases, IV, IV formulation, Stimufend®, Subcutaneous formulation, subcutaneous tocilizumab biosimilar, tocilizumab, tocilizumab biosimilar, tocilizumab-aazg, Tyenne®
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
Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release
Sandoz proposed biosimilar adalimumab (GP2017) shown to have equivalent efficacy and a similar safety profile as reference medicine, Humira®* Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis … Read the full press release
Posted in Germany, Healthcare, Science, Technology
Tagged Biosimilar, Humira, Mark Levick MD PhD, Sandoz
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