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Latest From Brenda Sandburg
Orexigen touts 39% growth in US sales of its obesity drug; agency objects to advertisement for excluding risk information.
Referencing opioids and suicidal thoughts is not sufficient, US regulators say; letter comes as Orexigen has seen an upsurge in Contrave prescriptions.
Budget proposal to fund state Medicaid programs through per capita cap or block grant would save $610bn over 10 years, administration says; budget calls for clarifying treatment of value-based pricing and fostering exchange of pre-approval information between manufacturers and payers.
Decision requiring suits to be filed in state where defendant is incorporated may deter consolidation of ANDA suits and increase venue fights; Court to hear challenge to PTAB inter partes review process.
Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.
Patent Trial and Appeal Board invalidates patent on method to treat rheumatoid arthritis; next hurdle is overcoming formulation patents that do not expire until 2022.