Dispute over analysis of inhaler device could delay launch of competitor to GSK's franchise until 2018; FDA's complete response letter to Mylan' deemed 'major.'
It doesn't appear there is going to be a quick fix to get Mylan NV's generic version of GlaxoSmithKline PLC's AdvairDiskus (fluticasone/salmeterol) to market. President Rajiv Malik told investors May 10 that the US FDA's complete response letter to its ANDA for Advair was deemed a "major CRL."
The company's first quarter sales and earnings release was the first chance investors have had to hear publicly from management...
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.
