Exclusive Drug Patent Licensing Deals Face New Scrutiny By FTC/DOJ
This article was originally published in The Pink Sheet Daily
The Federal Trade Commission finalized a proposed rule that requires pharma companies to report certain transactions transferring exclusive patent rights; PhRMA says annual costs will go far beyond FTC’s $1.2 million estimate.
You may also be interested in...
Federal Trade Commission is proposing to amend pre-merger notification rules related to the transfer of exclusive patent rights in the pharmaceutical industry; the change would require reporting transactions in which the licensor retains exclusive manufacturing rights.
Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.