Genentech, Inc.
About Genentech, Inc.
1698 articles about Genentech, Inc.
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Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
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FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
4/18/2024
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.
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Data from the Phase III OCARINA II study shows the subcutaneous version of Ocrevus achieved near-complete suppression of relapses and brain lesions in relapsing or primary progressive multiple sclerosis.
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Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS
4/17/2024
Genentech, a member of the Roche Group, announced data from the Phase III OCARINA II study of Ocrevus®, an investigational twice-yearly, 10-minute subcutaneous injection.
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Genentech’s Columvi Meets Primary Endpoint of Overall Survival in People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Study
4/15/2024
Genentech, a member of the Roche Group, announced the Phase III STARGLO study met its primary endpoint of overall survival.
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Roche said Monday that its bispecific T cell engager Columvi improved survival in a Phase III lymphoma trial, clearing the drugmaker to seek a full, expanded label that could drive sales growth.
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Roche’s Genentech subsidiary is terminating for undisclosed reasons its 2021 contract with Adaptimmune for the development of allogeneic T-cell therapeutics.
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According to Fresenius Kabi, Tyenne is the first biosimilar to Genentech’s Acterma which has both IV and subcutaneous formulations approved by the FDA.
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New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies
2/25/2024
Genentech, a member of the Roche Group, announced data from Stage 1 of the National Institutes of Health -sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and safety of Xolair® in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine and featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting.
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FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies
2/16/2024
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.
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New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)
2/1/2024
Genentech, a member of the Roche Group, announced new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® in macular edema due to branch and central retinal vein occlusion.
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After showing some unfavorable results for its data, AC Immune on Monday announced it will be getting back its Alzheimer’s disease candidates from Roche’s Genentech.
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When combined with Tecentriq and chemotherapy, tiroagolumab increased median survival to 15.7 months compared to 11.1 months for patients with esophageal squamous cell carcinoma on chemo alone.
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Brand pharmas not only leverage ancillary patents but sometimes hide or misrepresent information to the U.S. patent office in order to extend market exclusivity and high prices.
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FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results
12/19/2023
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with food allergy.
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New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma
12/11/2023
Genentech, a member of the Roche Group, announced that new data from its CD20xCD3 T-cell engaging bispecific antibody program, including eight oral presentations, were presented at the 65th American Society of Hematology Annual Meeting & Exposition, December 9-12, 2023.
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New Data Reinforce the Benefit of Early Preventative Treatment With Genentech’s Hemlibra (emicizumab-kxwh) for Babies With Severe hemophilia A
12/9/2023
Genentech, a member of the Roche Group, announced that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra® in previously untreated or minimally treated infants with severe hemophilia A without factor VIII inhibitors.
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Genentech’s Kadcyla Is the First Targeted Therapy to Show Significant Overall Survival Benefit in People With HER2-Positive Early-Stage Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment
12/8/2023
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive long-term follow-up data from the pivotal, Phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment.
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Genentech’s Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
12/8/2023
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today positive results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line treatment for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.
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Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
12/5/2023
Genentech, a member of the Roche Group, announced positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor -positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.