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Latest From Brenda Sandburg
Firms want Fifth Circuit to review whether federal law preempts failure-to-warn and design-defect claims; ruling in their favor could end 20,000-plus pending US cases.
Magistrate judge says Boehringer's theory 'may or may not be viable' as an infringement defense; permits third party subpoenas for information on clinical trials.
Court orders US FDA to award Bendeka seven years of exclusivity without requiring clinical superiority test; law codifying FDA policy passed prior to suit and is not retroactive.
Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.
Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices
Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.
US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.