PharmaEngine treated the first patient of phase Ib/II trial of PEP503 (NBTXR3) for head and neck cancer in Taiwan.
European Medicines Agency (EMA) granted the marketing authorization of ONIVYDE® in combination with 5-fluorouracil and leucovorin for the treatment of metastatic pancreatic adenocarcinoma patients who have progressed following gemcitabine-based therapy. PharmaEngine received the milestone payment of US$25.5 million.
Submission for CE Marking of PEP503 (NBTXR3) in Europe by Nanobiotix was accepted.
PharmaEngine won the Go-Global Gold Medal Award of Taipei Biotech Award 2016 hosted by Taipei City Government.
PharmaEngine gained the Gold Medal Award of BioTaiwan 2016.
ONIVYDE® regimen received a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the treatment of metastatic pancreatic adenocarcinoma.
PharmaEngine initiated the pivotal global trial of PEP503 (NBTXR3) in soft tissue sarcoma in Asia Pacific region.
Korean Ministry of Food and Drug Safety (MFDS) accepted the submission of new drug application (NDA) of ONIVYDE®. PharmaEngine acquired the milestone payment of US$10 million.
US National Comprehensive Cancer Network (NCCN) recognized the ONIVYDE® regimen as a category 1 second-line therapy in 2016 guidelines for metastatic pancreatic adenocarcinoma patients who have progressed following gemcitabine-based therapy.
Taiwan FDA approved the product license of ONIVYDE®.