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 Investor Update - August 16, 2022 Category: Pharmaceuticals Source Type: news
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
Camp Lejeune Veterans Win Justice
On Wednesday, Aug. 10, President Joe Biden signed the comprehensive Honoring Our PACT Act of 2022 into law, allowing military veterans and families harmed by contaminated water at Marine Corps Base Camp Lejeune to file lawsuits against the federal government.
The Camp Lejeune Justice Act of 2022, which focuses on four decades of water contamination, is just one part of the much broader PACT Act, which expands access to health care and disability benefits for veterans harmed by toxic exposures around the world.
Biden lauded the bipartisan support for the PACT Act at the signing.
“There are a lot of issues we can...
Source: Asbestos and Mesothelioma News - August 10, 2022 Category: Environmental Health Authors: Chris Elkins Tags: Veterans 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
WHO Reclassifies Firefighting as High-Risk Occupation for Cancer
The World Health Organization has reclassified firefighting to its highest level of occupational risk for cancer after extensive research confirmed an alarming level of malignant mesothelioma incidence.
The International Agency for Research on Cancer, which is part of WHO, found that firefighters had a 58% higher risk than the general population of developing mesothelioma, a rare cancer caused by exposure to asbestos fibers.
These findings led to the occupation being reclassified recently as “carcinogenic to humans,” earning it Group 1 status for cancer risk and confirming what many already believed.
“This r...
Source: Asbestos and Mesothelioma News - July 28, 2022 Category: Environmental Health Authors: Fran Mannino Tags: Asbestos Exposure Mesothelioma Source Type: news
AstraZeneca to acquire TeneoTwo and its clinical-stage T-cell engager
AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma(1).
The acquisition of TNB-486 aims to accelerate the development of this potential new medicine for B-cell haematologic malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. (Source: World Pharma News)
Source: World Pharma News - July 21, 2022 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry 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
How Jennifer Doudna ’s Life Has Changed Since Discovering CRISPR 10 Years Ago
Jennifer Doudna was staring at a computer screen filled with a string of As, Cs, Ts, and Gs—the letters that make up human DNA—and witnessing a debilitating genetic disease being cured right before her eyes. Just a year earlier, in 2012, she and microbiologist Emmanuelle Charpentier had published a landmark paper describing CRISPR-Cas9, a molecular version of autocorrect for DNA, and she was seeing one the first demonstrations of CRISPR’s power to cure a human disease. She was in the lab of Dr. Kiran Musunuru, a Harvard researcher who was eager to show her the results from an experiment he had just finish...
Source: TIME: Health - July 1, 2022 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized feature Genetics healthscienceclimate 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
Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting
Long-term data at the European Hematology Association (EHA) 2022 congress expands understanding of the impact of Roche medicines in early-stage blood cancers with the goal of providing patients with robust and durable outcomes from their first treatmentUpdated data from phase III CLL14 study of Venclexta ®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukaemia remained in remission five years after starting treatment[1]Final analysis of phase III GALLIUM study showed meaningful improvement in progression-free survival was main...
Source: Roche Investor Update - June 10, 2022 Category: Pharmaceuticals Source Type: news
Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting
Long-term data at the European Hematology Association (EHA) 2022 congress expands understanding of the impact of Roche medicines in early-stage blood cancers with the goal of providing patients with robust and durable outcomes from their first treatmentUpdated data from phase III CLL14 study of Venclexta ®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukaemia remained in remission five years after starting treatment[1]Final analysis of phase III GALLIUM study showed meaningful improvement in progression-free survival was main...
Source: Roche Media News - June 10, 2022 Category: Pharmaceuticals Source Type: news
The Unsettled —and Unsettling—Science of Lawn Chemicals
For people with yards, keeping grass lush can often feel like a full-time job: planting, treating, mowing, bug-killing, watering—and repeating. Because of the many products and services this entails, the lawn and garden care industry raked in $16.8 billion globally in 2020, according to analytics firm Allied Market Research.
But the roots of lawn care are more sinister than a bright lawn might suggest. Fertilizer grew in popularity after World War II, when the factories that made vast quantities of nitrogen for bombs diverted that production capacity toward agriculture. Around the same time, the insecticide DDT&mdash...
Source: TIME: Health - June 9, 2022 Category: Consumer Health News Authors: Tik Root Tags: Uncategorized Evergreen freelance healthscienceclimate Public Health Source Type: news
European Commission approves Roche ’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma
Lunsumio® (mosunetuzumab) is the first CD20xCD3 T-cell engaging bispecific antibody available to treat the most common slow-growing form of non-Hodgkin lymphoma, follicular lymphoma (FL)Lunsumio represents a new type of immunotherapy that is a chemotherapy-free, off-the-shelf, fixed-duration treatment option that could improve outcomes for people who have relapsed or are refractory to multiple previous treatmentsApproval is based on the phase I/II GO29781 study, whereLunsumio induced high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pre-treated FLBa...
Source: Roche Media News - June 8, 2022 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma
Lunsumio® (mosunetuzumab) is the first CD20xCD3 T-cell engaging bispecific antibody available to treat the most common slow-growing form of non-Hodgkin lymphoma, follicular lymphoma (FL)Lunsumio represents a new type of immunotherapy that is a chemotherapy-free, off-the-shelf, fixed-duration treatment option that could improve outcomes for people who have relapsed or are refractory to multiple previous treatmentsApproval is based on the phase I/II GO29781 study, whereLunsumio induced high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pre-treated FLBa...
Source: Roche Investor Update - June 8, 2022 Category: Pharmaceuticals Source Type: news
