US FDA is approving generics at record pace, providing important statistics to support efforts by Commissioner Gottlieb to position the agency as part of the solution to concerns about high drug prices; new guidance for industry and FDA reviewers, however, suggests there is still a need for more rigor in preparing and assessing submissions.
The US FDA is duly proud of its recent ANDA approval metrics: 171 approvals and 37 tentative approvals in the first two months of fiscal 2018 (October and November 2017).
Commissioner Scott Gottlieb touted the higher number of approvals in a Jan. 3 statement that pointed to November’s...
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.
