Basel, 06 December 2017 FDA grants Roche’s Avastin full approval for most aggressive form of brain cancer Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as... Read more
Basel, 05 December 2017 TECENTRIQ GO29695 (NCT02431208) and BO29562 (NCT02631577) FDA partial clinical hold lifted Roche (SIX: RO, ROG; OTCQX: RHHBY): today announced that following close consultation and agreement on study modifications with the U.S. Food and Drug Administration (FDA), the partial clinical holds placed on the Phase Ib and Phase Ib/II studies evaluating TECENTRIQ... Read more
Basel, 04 December 2017 FDA approves Foundation Medicine’s FoundationOne CDx, the first pan-tumour comprehensive genomic profiling assay incorporating a broad range of companion diagnostics Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved FoundationOne CDx™, Foundation Medicine’s comprehensive companion diagnostic assay for personalised oncology care1. FoundationOne... Read more
Basel, 20 November 2017 Roche’s Hemlibra significantly reduced bleeds in phase III study in haemophilia A HAVEN 3 study met primary endpoint and key secondary endpoints Intra-patient comparison demonstrated superiority of Hemlibra prophylaxis compared to prior factor VIII prophylaxis Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the phase III HAVEN 3... Read more
Basel, 20 November 2017 Roche’s Hemlibra significantly reduced bleeds in phase III study in haemophilia A HAVEN 3 study met primary endpoint and key secondary endpoints Intra-patient comparison demonstrated superiority of Hemlibra prophylaxis compared to prior factor VIII prophylaxis Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the phase III HAVEN 3... Read more
Basel, 20 November 2017 Phase III IMpower150 study showed Roche’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer Data will be submitted to health authorities globally, including the US Food and Drug Administration (FDA)... Read more
Basel, 20 November 2017 Phase III IMpower150 study showed Roche’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer Data will be submitted to health authorities globally, including the US Food and Drug Administration (FDA)... Read more
Basel, 17 November 2017 Roche to acquire Viewics, Inc. to provide data-driven lab business analytics and add further digital capabilities along the laboratory value chain The Viewics solution allows for efficient integration of big data from a variety of IT systems in the laboratory and beyond, pioneering a new way in extracting, cleansing, transforming and... Read more
Basel, 17 November 2017 FDA approves Roche’s Gazyva for previously untreated advanced follicular lymphoma The first treatment option to demonstrate superior progression-free survival over standard-of-care Rituxan-based therapy Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in... Read more
Basel, 16 November 2017 FDA approves Roche’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors First new medicine in nearly 20 years to treat people with haemophilia A with inhibitors Hemlibra substantially reduced bleeds in adults and children Only medicine that can be self-administered once weekly by injection under the skin (subcutaneously) Roche (SIX: RO, ROG;... Read more