Basel, 31 August 2017 Roche to present new data from its oncology portfolio at the 2017 European Society for Medical Oncology (ESMO) Congress Data from 18 approved and investigational cancer medicines to be presented at ESMO 2017 Results for Zelboraf (vemurafenib) as an adjuvant treatment for BRAF V600 mutation-positive melanoma to feature in the ESMO... Read more
Basel, 30 August 2017 FDA approves Roche’s Actemra/RoActemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome Actemra/RoActemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy CAR T cell therapy is an immunotherapy designed for the treatment of certain cancers This is the... Read more
Basel, 30 August 2017 FDA approves Roche’s Actemra/RoActemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome Actemra/RoActemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy CAR T cell therapy is an immunotherapy designed for the treatment of certain cancers This is the... Read more
Basel, 28 August 2017 FDA grants Priority Review for Roche’s Gazyva in previously untreated follicular lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva... Read more
Basel, 24 August 2017 FDA grants Priority Review to Roche’s emicizumab for haemophilia A with inhibitors Application based on positive results of phase III study in adolescents and adults with haemophilia A with inhibitors and interim phase III results in children Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug... Read more
Basel, 03 August 2017 FDA grants Roche’s Alecensa Priority Review for initial treatment of people with ALK-positive lung cancer Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa® (alectinib) as an initial (first-line)... Read more
– Concept amplifies impact of diagnostics to help improve patient management – Integrates connected core lab with automation, IT solutions, analytics and tests with high medical value The Roche booth at the 2017 AACC Clinical Lab Expo will feature a virtual reality experience that allows attendees to take a self-guided tour through three types of... Read more
Basel, 28 July 2017 FDA grants breakthrough therapy designation for Venclexta in acute myeloid leukaemia First in class BCL2-specific oral inhibitor represents a potential new way of treating acute myeloid leukaemia (AML), the most common type of aggressive leukaemia in adults1 17th breakthrough therapy designation for Roche’s portfolio of medicines and 4th for Venclexta Roche... Read more
Basel, 21 July 2017 Roche gains positive CHMP opinion for Actemra / RoActemra in giant cell arteritis If approved, Actemra/RoActemra would be the first therapy for the treatment of giant cell arteritis (GCA) in Europe GCA can lead to blindness, aortic aneurysm or stroke if left untreated The positive opinion is based on the outcome... Read more
Basel, 21 July 2017 CHMP recommends EU approval of Roche’s Gazyvaro for people with previously untreated advanced follicular lymphoma Pivotal GALLIUM study demonstrated that Gazyvaro-based treatment helped people with previously untreated follicular lymphoma live significantly longer without disease progression compared to MabThera-based treatment Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee... Read more