Daiichi Sankyo-partnered anti-HER2 drug Enhertu (trastuzumab deruxtecan) has been cleared by the European Commission for use ...
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone ...
The APPA, if passed into law, puts an upper limit of 20 patents, but only of certain types of patents (see below), that can be asserted in a BPCIA litigation (the APPA does not affect ANDA litigations ...