In effort to speed competition and lower drug prices, US regulator will prioritize review of generic drug applications likely to be ready for approval on or shortly after the expiration of first-filer's exclusivity; experts say the move appears to formalize what once had been an informal Office of Generic Drugs policy.
With the US FDA's announcement that it will prioritize review of abbreviated new drug applications (ANDAs) ready for approval once a first generic's marketing exclusivity expires, the agency appears to be formalizing an informal generic review division policy, with the aim of speeding competition and lowering drug prices.
On Nov. 9, FDA announced it would consider for priority review those generic drug applications that are likely to be...
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.
