Genentech, Inc.
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Biosimilars effectively lowered cancer therapy Herceptin prices and made trastuzumab more accessible to patients, finds a new study from the USC Schaeffer Center.
Fenebrutinib in a mid-phase trial reduced brain legions in relapsing forms of multiple sclerosis, the company reported. It is the only reversible BTK inhibitor currently in Phase III MS trials.
Polivy is approved for front-line DLBCL as part of a combination regimen including Rituxan, cyclophosphamide, doxorubicin and prednisone.
Roche, AstraZeneca, Moderna, Merck and Affimed presented new data in liver cancer, lung cancer, melanoma and lymphoma.
There have already been several big biotech licensing deals in Q1. See inside for some of this quarter’s biggest licensing deals — from the surprising and pivotal to the lucrative and consequential.
The FDA is expected to make decisions on Emergent BioSolutions’ sNDA for OTC Narcan and Roche’s Polivy in frontline DLBCL.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
The FDA’s Oncologic Drugs Advisory Committee will meet March 9 to discuss Roche’s sBLA for Polivy in first-line DLBCL, while Acadia awaits potential approval of the first therapy for Rett Syndrome.
Data from a Phase III study show Genentech’s crovalimab is non-inferior to AstraZeneca’s Soliris, the current standard of care in paroxysmal nocturnal hemoglobinuria (PNH).
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