In the course of a week, Teva received final ANDA approval for cinacalcet, launched its generic and reached a deal with Amgen to come off the market until mid-2021. The fast but short launch allowed Teva to take some sales away from Amgen without triggering entry of other ANDA sponsors who previously settled, Bernstein Senior Analyst Ronny Gal says.
Teva Pharmaceutical Industries Ltd.’s abbreviated US launch of the first Sensipar (cinacalcet) generic may have been just long enough to grab a small piece of Amgen Inc.’s lucrative market for the blockbuster calcium-sensing receptor agonist, but short enough not to trigger entry by other generic sponsors who previously settled patent litigation with Amgen.
The launch of Teva’s generic cinacalcet, which was quickly followed by a patent litigation settlement, also suggests that if Amgen...
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.
