Seroquel Generics Suit Is AstraZeneca’s Bid To Control Diabetes Safety Data
FDA nearly always prevails in lawsuits that challenge generic approvals, but AstraZeneca’s argument is relatively fresh and could be bolstered by the agency’s decision to deny the firm’s citizen petition without comment.
You may also be interested in...
Updated drug pricing bill would allow US FDA to approve generics even if innovator safety information is protected by exclusivity.
Sanofi follows Janssen in teaming up with HHS' BARDA to develop a COVID-19 vaccine; using technology platform of its Flublok vaccine, Sanofi expects to enter clinical trials in 1 to 1 ½ years.
Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.