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PharmaEngine's "Onivyde" approved by the European Medicines Agency (EMA) and launched in GermanyMay 14, 2024

PharmaEngine announced on the 13th that its international partner, Servier, has obtained approval from the European Medicines Agency (EMA) for a change in indication and dosage for "Onivyde" in the European Union. The new indication approved by the EMA is for the treatment of metastatic pancreatic cancer, in combination with oxaliplatin, 5-fluorouracil, and leucovorin, as a first-line treatment for patients, and it will be launched in Germany.

PharmaEngine stated that another licensing partner, Ipsen, formally notified PharmaEngine on the 13th that it will receive a sublicense revenue of $1.875 million.

According to data from the World Health Organization (WHO) Cancer Today, in 2022, there were a total of 515,700 people diagnosed with pancreatic malignant tumors globally, and there were a total of 466,983 deaths due to pancreatic malignant tumors that year.

Resource (Mandarin):

智擎「安能得」獲歐盟藥品管理局 EMA 核准並在德國上市