Patients and RWE: Is this the year?
The long-hyped redefinition of healthcare through wearable tech has been … well, long hyped. Early projects, such as Apple HealthKit and Fitbit, were undoubtably important in redefining ‘the possible’ but they haven’t yet achieved transformative application. Much has been written on why the philosophy that has driven the astonishing success of consumer technology doesn ’t translate to healthcare and when we look at the state of innovation in 2020, many of these structural issues remain. As Emily Cerciello, Associate Director, Digital Health and Engagement at the Crohn ' s& Colitis Foundation states, ...
Source: EyeForPharma - March 26, 2020 Category: Pharmaceuticals Authors: Tom Disley Source Type: news
Relapse With Rituximab More Common in Severe Pemphigus Relapse With Rituximab More Common in Severe Pemphigus
Pemphigus patients with severe disease and those with persistent anti-desmoglein (DSG) antibodies three months after starting treatment with rituximab are more prone to relapse while on the drug, according to a new post hoc analysis of a randomized clinical trial.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 25, 2020 Category: Consumer Health News Tags: Medscape Today News Source Type: news
FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels
FDA approves Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children ages 2 and older in combination with steroid hormones. It is the first approved treatment for children with these rare vasculitis diseases. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 25, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Roche announces Venclexta/Venclyxto combination improved overall survival in people with previously untreated acute myeloid leukaemia
Basel, 23 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta ®/Venclyxto® (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta/Venclyxto plus azacitidine appeared consistent with the known safety profile of the...
Source: Roche Investor Update - March 23, 2020 Category: Pharmaceuticals Source Type: news
Roche announces Venclexta/Venclyxto combination improved overall survival in people with previously untreated acute myeloid leukaemia
Basel, 23 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta ®/Venclyxto® (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta/Venclyxto plus azacitidine appeared consistent with the known safety profile of the...
Source: Roche Media News - March 23, 2020 Category: Pharmaceuticals Source Type: news
European Commission approves Venclyxto plus Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia
Basel, 12 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto ® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).“Venclyxto plus Gazyvaro is the first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This is an im...
Source: Roche Media News - March 12, 2020 Category: Pharmaceuticals Source Type: news
European Commission approves Venclyxto plus Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia
Basel, 12 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto ® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).“Venclyxto plus Gazyvaro is the first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This is an im...
Source: Roche Investor Update - March 12, 2020 Category: Pharmaceuticals Source Type: news
Structure of CD20 in complex with the therapeutic monoclonal antibody rituximab
Cluster of differentiation 20 (CD20) is a B cell membrane protein that is targeted by monoclonal antibodies for the treatment of malignancies and autoimmune disorders but whose structure and function are unknown. Rituximab (RTX) has been in clinical use for two decades, but how it activates complement to kill B cells remains poorly understood. We obtained a structure of CD20 in complex with RTX, revealing CD20 as a compact double-barrel dimer bound by two RTX antigen-binding fragments (Fabs), each of which engages a composite epitope and an extensive homotypic Fab:Fab interface. Our data suggest that RTX cross-links CD20 i...
Source: ScienceNOW - March 11, 2020 Category: Science Authors: Rouge, L., Chiang, N., Steffek, M., Kugel, C., Croll, T. I., Tam, C., Estevez, A., Arthur, C. P., Koth, C. M., Ciferri, C., Kraft, E., Payandeh, J., Nakamura, G., Koerber, J. T., Rohou, A. Tags: Biochemistry, Immunology r-articles Source Type: news
Rituximab with BEAM Conditioning Prior to Auto-HCT for DLBCL not Recommended
This recommendation was based on an analysis of patients with diffuse large B-cell lymphoma undergoing auto-HCT in which the addition of rituximab to the BEAM conditioning regimen had no impact on transplantation outcomes. (Source: CancerNetwork)
Source: CancerNetwork - February 27, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news
FDA accepts Roche ’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subc utaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinet ics)...
Source: Roche Investor Update - February 25, 2020 Category: Pharmaceuticals Source Type: news
FDA accepts Roche ’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subc utaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinet ics)...
Source: Roche Media News - February 25, 2020 Category: Pharmaceuticals Source Type: news
Roche announces CHMP recommendation for EU approval of Venclyxto plus Gazyvaro for people with untreated chronic lymphocytic leukaemia
Basel, 31 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adults with previously untreated chronic lymphocytic leukaemia (CLL).“Despite advances in treating chronic lymphocytic leukaemia, many patients cannot tolerate the side effects of chemotherapy-containing regimens,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We’r...
Source: Roche Investor Update - January 31, 2020 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the European Commission has granted conditional marketing authorisation for Polivy ® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Media News)
Source: Roche Media News - January 21, 2020 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the European Commission has granted conditional marketing authorisation for Polivy ® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Investor Update)
Source: Roche Investor Update - January 21, 2020 Category: Pharmaceuticals Source Type: news
Diego Villa, MD, FRCPC, Discusses Bendamustine and Rituximab as Induction Therapy in MCL
Diego Villa, MD, FRCPC, elaborated on the progress made with bendamustine and rituximab as induction therapy for transplant eligible and ineligible patients with mantle cell lymphoma. (Source: CancerNetwork)
Source: CancerNetwork - January 3, 2020 Category: Cancer & Oncology Authors: Diego Villa, MD, FRCPC Source Type: news
