New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma
Basel, 07 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy ® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not eligible for stem cell transplant. Updated data from the randomised cohort (n=80) show that with longer follow-up (48.9 months) a complete response (CR) rate of 42.5% (n=17/40) was maintained in patien...
Source: Roche Investor Update - December 7, 2020 Category: Pharmaceuticals Source Type: news

New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma
Basel, 07 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy ® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not eligible for stem cell transplant. Updated data from the randomised cohort (n=80) show that with longer follow-up (48.9 months) a complete response (CR) rate of 42.5% (n=17/40) was maintained in patien...
Source: Roche Media News - December 7, 2020 Category: Pharmaceuticals Source Type: news

New follow-up phase III data reinforce the long-term benefit of Roche ’s Hemlibra for people with haemophilia A
Basel, 7 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra ® (emicizumab).[1]These data, from adults, adolescents and children with haemophilia A with and without factor VIII inhibitors, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 5-8 December 2020.“The long-term benefit of Hemlibra, with a consistent safety profile and durably effective con...
Source: Roche Investor Update - December 7, 2020 Category: Pharmaceuticals Source Type: news

New follow-up phase III data reinforce the long-term benefit of Roche ’s Hemlibra for people with haemophilia A
Basel, 7 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra ® (emicizumab).[1]These data, from adults, adolescents and children with haemophilia A with and without factor VIII inhibitors, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 5-8 December 2020.“The long-term benefit of Hemlibra, with a consistent safety profile and durably effective con...
Source: Roche Media News - December 7, 2020 Category: Pharmaceuticals Source Type: news

New Data Demonstrate Long-Term Benefit of IMBRUVICA ® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia
This study highlighted the need for cytogenetic/molecular testing before CIT treatment, consistent with clinical treatment guidelines.[8],[9]Real-World Prognostic Biomarker Testing, Treatment Patterns, And Dosing Among Patients With CLL/SLL From the informCLL™ Prospective Observational Registry (Abstract #547)An oral presentation on Monday, December 7, will feature results from the informCLL™ real-world prospective observational registry assessing treatment patterns in the era of novel agents.4 Key Study Findings:· The most common index treatment was IMBRUVICA®; the majority of patients treated with IMBRUVICA® remai...
Source: Johnson and Johnson - December 6, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia
             Basel, 5 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta ®/Venclyxto® (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday 5 December 2020.“These results reinforce the long-term value of fixed-duration,...
Source: Roche Media News - December 5, 2020 Category: Pharmaceuticals Source Type: news

Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia
             Basel, 5 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta ®/Venclyxto® (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday 5 December 2020.“These results reinforce the long-term value of fixed-duration,...
Source: Roche Investor Update - December 5, 2020 Category: Pharmaceuticals Source Type: news

Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA ® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
December 5, 2020 (RARITAN, N.J.) – New data from the Phase 2 CAPTIVATE study were presented today during an oral session at the 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The study evaluated the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax in the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and showed that, after achieving undetectable minimal residual disease (uMRD) in both the blood and bone marrow with the IMBRUVICA® combination regimen, the one-year disease-free survival (DFS) of patients randomized to discont...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

FDA approves Xolair ® (omalizumab) for adults with nasal polyps
             Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment ...
Source: Roche Media News - December 1, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Xolair ® (omalizumab) for adults with nasal polyps
             Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment ...
Source: Roche Investor Update - December 1, 2020 Category: Pharmaceuticals Source Type: news

Janssen Headlines American Society of Hematology Annual Meeting With More Than 35 Presentations Highlighting Deep, Diverse Oncology Pipeline and Portfolio
RARITAN, N.J., November 5, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today more than 35 company-sponsored studies, including 10 oral presentations, will be featured at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.In multiple myeloma, highlights include Phase 1b/2 results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel); new and updated data for the anti-CD38 monoclonal antibody DARZALEX® (daratumumab) and the subcutaneous for...
Source: Johnson and Johnson - November 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

14.10.20: Not intended for U.S. and UK Media
Combination of copanlisib and rituximab significantly prolonged progression-free survival of patients with relapsed indolent non-Hodgkin's LymphomaPhase III study CHRONOS-3 in patients with relapsed indolent non-Hodgkin's Lymphoma (iNHL) who have received one or more lines of prior treatment meets primary endpoint / Safety and tolerability observed in the trial were generally consistent with previously published data on the individual components of the combination and no new safety signals were identified / Copanlisib is already approved in the U.S. under accelerated approval based on overall response rate (ORR) of 104 adu...
Source: Bayer IR Newsfeed: Events - October 14, 2020 Category: Pharmaceuticals Source Type: news

Innovent and Lilly Jointly Announce the NMPA Granted Marketing Approval for HALPRYZA(R) (Rituximab Injection) in China
SAN FRANCISCO and SUZHOU, China, Oct. 9, 2020 -- (Healthcare Sales & Marketing Network) -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for... Biopharmaceuticals, Oncology, Regulatory Innovent Biologics, Eli Lilly, HALPRYZA, rituximab (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 9, 2020 Category: Pharmaceuticals Source Type: news

Novel Radioimmunotherapy Reverses Resistance to Commonly Used Lymphoma Drug
(Society of Nuclear Medicine and Molecular Imaging) A new radioimmunotherapy has proven effective in reversing resistance to the most commonly used lymphoma drug, rituximab, according to research published in the October issue of The Journal of Nuclear Medicine. When used in combination with rituximab, 177Lu-lilotomab-satetraxetan was shown to substantially increase rituximab binding and rituximab-mediated antibody-dependent cellular cytotoxicity (ADCC) activity, resulting in significant tumor growth delay in a non-Hodgkin's lymphoma mouse model. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 8, 2020 Category: Cancer & Oncology Source Type: news

SIMPONI ARIA ® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. “This latest FDA approval of SIMPONI ARIA for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment,” said Mathai Mammen, M.D., Ph.D., Global Head, Jans...
Source: Johnson and Johnson - September 30, 2020 Category: Pharmaceuticals Source Type: news