Performance numbers are likely to fluctuate over the course of the program, but the rate of first-cycle approvals during the first month of the new user fee program is more than double the rate during the last year of the old iteration.
GDUFA II began with a much higher first-cycle ANDA approval rate than has been seen in previously, a promising sign as the US FDA works to increase generic approvals in the hopes of lowering drug prices.
The agency's Office of Generic Drugs reported 26 full first-cycle approvals out of 87 issued in October, the first month...
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.
