Only 14 of the 170 brand-generic patent suit settlements in US during FY 2015 potentially involve payments to delay generics; number drops to 5 when payments for litigation fees are excluded.
The US Federal Trade Commission's annual report on brand-generic patent dispute settlements suggests companies are structuring these agreements to avoid legal challenges. For the third consecutive year, the number that could potentially be "pay-for-delay" deals has dropped.
FTC's report on fiscal year 2015 patent settlements says 14 of the 170 agreements filed during the year may...
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.
