Persistent data integrity and quality unit failures at two Apotex plants in Bangalore, India, led to wholesale US market withdrawals by the Canadian generic drug manufacturer.
It appears that the US Food and Drug Administration’s growing frustration with a Canadian drug maker’s continuing failure to establish an effective quality system and ensure data integrity at two facilities in India has led to the firm’s withdrawal of 31 generic drug approvals listed in a Federal Register notice slated for publication on 10 July.
Apotex Inc.’s decision to withdraw the abbreviated new drug applications is an unprecedented outcome of the data integrity crisis...
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.
