FDA accepts supplemental Biologics License Application for Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
First new treatment regimen in more than 20 years to significantly improve outcomes in people with this fast-growing type of lymphomaApplication is based on pivotal data from the phase III POLARIX study showing Polivy plus R-CHP significantly reduced therisk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOPVarious combination studies with Polivy and the company ' s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoingBasel, 16 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the compan...
Source: Roche Media News - August 16, 2022 Category: Pharmaceuticals Source Type: news
European Commission Approves IMBRUVICA ® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, 4 August 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission granted marketing authorisation for the expanded use of IMBRUVICA® (ibrutinib) in an all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). The approval is based on the pivotal Phase 3 GLOW study that demonstrated superior progression-free survival (PFS) in patients treated with I+V versus chlorambucil-obinutuzumab (Clb+O), and the FD cohort of the Phase 2 CAPTIVATE study, which showed deep ...
Source: Johnson and Johnson - August 4, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Roche ’s subcutaneous formulation of Tecentriq demonstrates positive Phase III results
IMscin001 study showed non-inferior levels of cancer immunotherapyTecentriq in the blood, when injected subcutaneously, compared to intravenous infusion, in people with advanced non-small cell lung cancerAdministered under the skin, the subcutaneous formulation reduces time spent receiving treatment to just minutes, compared with up to an hour for IV infusionData will be submitted to health authorities globally, including the US Food and Drug Administration and European Medicines AgencyBasel, 2 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMscin001 study evaluating a subcutaneous form...
Source: Roche Media News - August 2, 2022 Category: Pharmaceuticals Source Type: news
Off-Label Drug Lowers Relapses in Multiple Sclerosis
(MedPage Today) -- Off-label rituximab (Rituxan) led to fewer relapses over 2 years than dimethyl fumarate (Tecfidera) in people with early relapsing-remitting multiple sclerosis (MS), the phase III RIFUND-MS trial showed.
Relapses occurred in... (Source: MedPage Today Neurology)
Source: MedPage Today Neurology - July 21, 2022 Category: Neurology Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Basel, 21 July 2022Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follic...
Source: Roche Media News - July 21, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follicular lymphoma) andT...
Source: Roche Investor Update - July 21, 2022 Category: Pharmaceuticals Source Type: news
Cancer Med Might Be Powerful Treatment for MS
THURSDAY, July 14, 2022 -- A drug used " off-label " for multiple sclerosis (MS) is more effective than a standard medication at preventing symptom flare-ups, a new clinical trial has found.
The drug, called rituximab, is approved in the United States... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 14, 2022 Category: General Medicine Source Type: news
Cancer Med, Rituximab, Might Be Powerful Treatment for MS
THURSDAY, July 14, 2022 -- A drug used " off-label " for multiple sclerosis (MS) is more effective than a standard medication at preventing symptom flare-ups, a new clinical trial has found.
The drug, called rituximab, is approved in the United... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 14, 2022 Category: General Medicine Source Type: news
New data from phase III HAVEN 6 study reinforce favourable safety and efficacy profile of Roche ’s Hemlibra in people with moderate or mild haemophilia A
Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mildhaemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up [1]New data also reinforceHemlibra ’sfavourable safety profile, with no new safety signals observed [1]There is limited information and treatment guidance on moderate and mildhaemophilia A, which can lead to delayed or missed diagnoses of bleeding episodes [2]Hemlibra is approved to treat people of all ages withhaemophilia A with factor VIII inhibitors in more than 110 countries and for people of all ages without factor VIII in...
Source: Roche Media News - July 11, 2022 Category: Pharmaceuticals Source Type: news
New data from phase III HAVEN 6 study reinforce favourable safety and efficacy profile of Roche ’s Hemlibra in people with moderate or mild haemophilia A
Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mildhaemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up [1]New data also reinforceHemlibra ’sfavourable safety profile, with no new safety signals observed [1]There is limited information and treatment guidance on moderate and mildhaemophilia A, which can lead to delayed or missed diagnoses of bleeding episodes [2]Hemlibra is approved to treat people of all ages withhaemophilia A with factor VIII inhibitors in more than 110 countries and for people of all ages without factor VIII in...
Source: Roche Investor Update - July 11, 2022 Category: Pharmaceuticals Source Type: news
FDA grants Priority Review to Roche ’s Lunsumio for people with relapsed or refractory follicular lymphoma
Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphomaApplication is based on results from the pivotal phase I/II study showingLunsumio induced high and durable complete response rates in people with follicular lymphoma who received two or more prior therapiesLunsumio is a fixed-duration treatment option with the potential to be administered in an outpatient settingBasel, 6 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s B...
Source: Roche Investor Update - July 6, 2022 Category: Pharmaceuticals Source Type: news
FDA grants Priority Review to Roche ’s Lunsumio for people with relapsed or refractory follicular lymphoma
Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphomaApplication is based on results from the pivotal phase I/II study showingLunsumio induced high and durable complete response rates in people with follicular lymphoma who received two or more prior therapiesLunsumio is a fixed-duration treatment option with the potential to be administered in an outpatient settingBasel, 6 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s B...
Source: Roche Media News - July 6, 2022 Category: Pharmaceuticals Source Type: news
Janssen Receives Positive CHMP Opinion for IMBRUVICA ® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, June 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a new treatment option with IMBRUVICA® (ibrutinib) in an oral fixed-duration combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). Outcomes for patients with CLL have improved in the last decade with the advent of oral therapies that target the underlying disease biology.[1] This provides the opportunity...
Source: Johnson and Johnson - June 24, 2022 Category: Pharmaceuticals Source Type: news
Riabni (Rituximab-arrx Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - June 24, 2022 Category: Drugs & Pharmacology Source Type: news
New IMBRUVICA ® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new and updated results from the Phase 2 CAPTIVATE study evaluating IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) as a potential fixed-duration (FD) treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line tre...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
