- Oct.
PharmaEngine treated the first patient of phase Ib/II trial of PEP503 (NBTXR3) for head and neck cancer in Taiwan.
- Oct.
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.
- Sep.
Submission for CE Marking of PEP503 (NBTXR3) in Europe by Nanobiotix was accepted.
- Jul.
PharmaEngine won the Go-Global Gold Medal Award of Taipei Biotech Award 2016 hosted by Taipei City Government.
- Jul.
PharmaEngine gained the Gold Medal Award of BioTaiwan 2016.
- Jul.
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.
- May.
PharmaEngine initiated the pivotal global trial of PEP503 (NBTXR3) in soft tissue sarcoma in Asia Pacific region.
- May.
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.
- Mar.
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.
- Mar.
Taiwan FDA approved the product license of ONIVYDE®.