FTC's Generic Market Analysis Forcing Divestures Even In Diverse Categories
This article was originally published in The Pink Sheet Daily
Executive Summary
Hikma must divest rights to three drugs under Roxane Labs deal as Federal Trade Commission aims to preserve as many as five competitors in some markets.
You may also be interested in...
Teva, Allergan Generics: FTC Worried About A Multitude Of Markets, Not A Behemoth
Record-setting divestment order driven by sheer number of products where firms competed, not size of company that would result from acquisition.
Deal Watch: Boehringer’s Busy Week – An Acquisition, A Divestiture And A Discontinuation
Teva’s buyout of Allergan’s generics business should end speculation about a Teva/Mylan merger. A new Sanofi/Regeneron tie-up and an AstraZeneca divestiture to Sanofi’s Genzyme unit are among the latest developments in immuno-oncology.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.