Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering scarce details on the reason why or possible length of the delay.
Mylan NV’s setback is GlaxoSmithKline PLC’s advantage. Mylan announced March 29 that it received a “complete response” letter from the US FDA relating to its ANDA to market a generic version of GlaxoSmithKline PLC’s asthma blockbuster Advair Diskus (fluticasone/salmeterol), likely delaying a launch by months and possibly longer.
The question of whether or not Mylan’s generic would receive FDA approval has been a high-stakes game of will they...
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.
