Jul. 26, 2021
‘The award for most memorable drug approval goes to…’
It’s TV awards season, and an Emmy-worthy drama is unfolding around an unlikely subject: the U.S. Food and Drug Administration’s approval of Biogen, Inc.’s Aduhelm (aducanumab), a novel biologic for the treatment of Alzheimer’s disease.
James R. Ravitz
Partner
Jamie was a partner in Wilson Sonsini's life sciences practice, representing manufacturers and distributors of products regulated by the FDA, including medical devices, drugs, biologics, food, cannabis, dietary supplements, and cosmetic products. Before joining the firm, Jamie led the FDA and health care life sciences practice at Arent Fox in Washington.
Georgia C. Ravitz
Georgia was a partner in Wilson, Sonsini, Goodrich & Rosati PC's life sciences practice, where she specializes in FDA regulatory, health care, and consumer products innovation and compliance. Prior to joining the firm, Georgia was a senior partner in the FDA and advertising practices of Arent Fox in Washington, D.C., where she led the firm's consumer product safety practice.
David M. Hoffmeister
Partner
Wilson Sonsini Goodrich & Rosati PC
David plays a major leadership role in the firm's drug and device regulatory and health care law practice and brings more than 25 years of experience in drug and device regulatory and health care law. David was named as one of the "25 Leading Biotech Attorneys" in California in 2011 by the Daily Journal, and is recognized as one of the leading food and drug regulatory lawyers in the country.
It's TV awards season, and an Emmy-worthy drama is unfolding around an unlikely subject: the U.S. Food and Drug Administration's approval of Biogen, Inc.'s Aduhelm (aducanumab), a novel biologic for the treatment of Alzheimer's disease.
Let's set the scene:
On June 7, FDA approved Aduhelm through the accelerated approval pathway, a narrow regulatory paradigm reserved for drugs directed to serious co...
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