|Day's range||186.50 - 195.00|
|52-week range||145.01 - 212.51|
|PE ratio (TTM)||N/A|
|Dividend & yield||N/A (N/A)|
|1y target est||N/A|
TAIPEI, Taiwan, Oct. 18, 2016 /PRNewswire/ -- PharmaEngine, Inc. (TWO: 4162) announced that the European Commission (EC) has granted Shire plc (PharmaEngine's sublicensee, LSE: SHP, NASDAQ: SHPG) a marketing ...
TAIPEI, Taiwan, July 25, 2016 /PRNewswire/ -- PharmaEngine, Inc. (TWO:4162) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization of ONIVYDE® (irinotecan liposome injection, nal-IRI) in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine based therapy. The CHMP positive opinion for ONIVYDE will now be reviewed by the European Commission for marketing authorization in the European Union (EU).
The U.S. Food and Drug Administration approved Merrimack Pharmaceutical Inc's pancreatic cancer therapy Onivyde, but with a serious warning, marking the company's first ever drug to win regulatory clearance. The drug in combination with chemotherapy treatments 5-fluorouracil and leucovorin treats metastatic pancreatic cancer in patients, who have failed to respond to chemotherapy drug gemcitabine. Onivyde, however, carries a black box warning about severe risks of diarrhea and low white blood cell count, the agency said, adding that it was not approved for use as a single agent.