Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.
The final user fee reauthorization bill could contain several mechanisms geared toward improving generic competition in the marketplace, with the House Energy and Commerce Committee's Subcommittee on Health most recently adopting an amendment that would create breakthrough therapy-like provisions for potential competitors where no generic exists.
Subcommittee members voted to advance the marked up user fee legislation May 18 onto the full committee by a unanimous...
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.
