Genentech, Inc.

NEWS
FDA
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.
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.
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.
Roche’s Genentech subsidiary is terminating for undisclosed reasons its 2021 contract with Adaptimmune for the development of allogeneic T-cell therapeutics.
FDA
According to Fresenius Kabi, Tyenne is the first biosimilar to Genentech’s Acterma which has both IV and subcutaneous formulations approved by the FDA.
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.
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.
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.
A combination of Roche’s investigational treatment with Ibrance and fulvestrant met its primary endpoint of progression-free survival in the first-line setting in treating PIK3CA-mutated breast cancer.
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