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Latest From Brenda Sandburg
Union of Concerned Scientists' survey finds 65% of 354 respondents feel their direct supervisors back them on politically contentious positions; Commissioner Gottlieb gets glowing reviews.
Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.
"Tipping point" occurred when Phigenix changed theory that Genentech's Kadcyla infringed its patent; CEO may be on hook for attorneys' fees.
US FDA responds to comments on proposed study of product disclosures and study of amount and location of risk information.
Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention
Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.
Legality Of J&J's Remicade Contracting Depends On Share Of Biosimilar Market Foreclosed, Court Rules
Court denies J&J's motion to dismiss Pfizer's antitrust suit, saying discovery will reveal whether Pfizer has offered more competitive pricing for its Inflectra biosimilar and if there are alternative causes for Pfizer's inability to gain market share.