Increases in the number of expected ANDA submissions, facilities and entities holding approved applications means lower user fees in most GDUFA II categories starting 1 October; program fee will see the largest percentage drop, amounting to savings of $200,000 for large companies.
The US Food and Drug Administration filing fee for an abbreviated new drug application will drop slightly in fiscal year 2020, thanks to a higher number of generic drug applications expected to be submitted in the coming year.
The ANDA filing fee beginning on 1 October will be $176,237, which is $2,562, or 1.4%, below the current rate,...
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.
