New drug review elements that could benefit complex generics include a two-month filing review period before the user fee clock is triggered, more interaction between the agency and a sponsor during the review, and an opportunity for a company to have in-depth discussions with the FDA after receipt of a complete response letter, Teva’s Scott Tomsky says at kick-off meeting for next iteration of the generic drug user fee agreement.
The third iteration of the generic drug user fee agreement should incorporate elements from the new drug review side to increase regulatory predictability, review transparency and the first-cycle approval rate for complex generics, Teva Pharmaceutical Industries Ltd. believes.
The US Food and Drug Administration and the generic drug industry should take some lessons from the way the agency...
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.
