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Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

The ODAC Losing Streak Ends

US FDA’s Oncologic Drugs Advisory Committee’s endorsement of a first-line indication for Genentech’s Polivy is the first time the panel has voted ‘yes’ on a cancer drug application in almost three years.

Advisory Committees Drug Review

Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval

Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.

Advisory Committees Coronavirus COVID-19

Galderma Readies Its First Therapeutic Biologic For Two US Launches In 2024

Galderma said its IL-31 receptor alpha inhibitor nemolizumab succeeded in two Phase III atopic dermatitis trials, advancing the firm’s long-term goal of moving past topical dermatology drugs.

Strategy Dermatology

Biogen And Millennium May Be Ensnared In Tentacles Of Genentech’s Expired Cabilly Patent

Genentech claims Biogen and Millennium owe royalties on sales of Tysabri and Entyvio that were stockpiled when the Cabilly patent expired. Hospira faced similar litigation over its erythropoietin biosimilar and had to pay Amgen $70m in damages.

Intellectual Property Legal Issues
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