Xtandi March-In Fight Extended to Paxlovid, Insulin, HIV, Asthma And Hepatitis C Drugs
In drug pricing move, Public Citizen and others petition HHS Secretary Becerra to use government authorities to get generic versions of six drugs on the market before patent expiration.
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In the wake of a favorable US Court of Appeals for the Federal Circuit decision, Viatris has won FDA approval for the first generic Symbicort product. The ANDA sponsor’s management had recently declared itself “ready to launch if the opportunity presents itself in 2022.”
Prostate cancer patients press HHS for administrative hearing on march-in rights for patents covering Astellas’ Xtandi. While previous efforts have failed, petitioners believe they may have a shot this time around given Biden Administration and HHS Secretary Becerra’s views on the issue.
KEI vows to continue battle over Bayh-Doyle restrictions after US Commerce Department suggests it may issue regulations to exclude pricing as a basis for requiring companies to license their patents.