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Latest From Apotex Inc.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
Apotex’ 505(b)(2) new drug application rival to Alimta will stay off the US market after the Federal Circuit found that a lower court had correctly concluded that prosecution history estoppel did not bar Lilly’s infringement claims against the Canadian firm under the doctrine of equivalents.
Perrigo, Pfizer want FDA to postpone its March deadline for conducting nitrosamine risk assessments. Generics executive cites “serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
Executive Decisions: Hardwick Heads US Apotex, Stada Adds To German Management, Lovett Leads Nutrition21 Marketing, More
Hardwick heads Apotex in US; DSM expands cycling team support; Stada adds to Germany management; Lovett leads Nutrition21 marketing; Viatris appoints head of capital markets; and Redcon1 sponsors bodybuilder Greene, wrestler Omega.
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