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Latest From Genentech, Inc.
Private Company Edition: Amylyx will use its new cash to run a Phase III trial and submit applications seeking EU and Canadian approvals of AMX0035, but US filing plans based on prior Phase II/III data are less clear. Also, three VC firms raised new funds targeting biopharma and other investments.
Ruling keeps the principle of assignor estoppel in place, but restricts its use to situations where an inventor’s claims in court directly contradict those in the patent.
After a searing advisory committee on aducanumab, FDA reviewers undertook an extensive effort to counter or discount the panel’s criticisms, newly released review documents show. Among the unusual moves by the agency was the citation of data from two investigational products, Lilly’s donanemab and Biogen/Eisai’s BAN2401, as evidence in support of aducanumab.
The ruling keeps the principle of assignor estoppel in place, but limits its use to situations where an inventor’s claims in court directly contradict those in the patent.
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