US FDA rejects Allergan's third citizen petition seeking to require comparative clinical trials of generic versions of its dry eye medicine; company appeals patent invalidity ruling and PTAB admonishes Mohawk Tribe for its actions in IPR proceeding.
Allergan PLC has been tenacious in trying to get the US FDA to impose more stringent standards for approval of generic versions of its dry eye medicine Restasis (cyclosporine). But the agency 's rejection of its third citizen petition shows this strategy is unlikely to block generic competition.
The three petitions – submitted in February 2014, December 2014 and August 2017 – oppose FDA's decision to allow generic...
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
Private Company Edition: June’s eight $100m-plus venture capital rounds already outpace the seven each raised in March, April and May, including €255m ($274.2m) for ITM and $200m for Upstream, but while there were five $25m or less VC financings during the past week, mid-sized deals were lacking.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
