20:43 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Dec. 14, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The...
23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
01:53 , Dec 30, 2016 |  BC Week In Review  |  Clinical News

Ropeginterferon alfa-2b: Final Ph III PROUD-PV data

Final data from the open-label, European Phase III PROUD-PV trial in 254 patients with PV showed that 50-500 µg subcutaneous ropeginterferon alfa-2b every other week was non-inferior to once-daily oral hydroxyurea in the proportion of...
07:00 , Mar 16, 2015 |  BC Week In Review  |  Clinical News

PEG-P-INF alfa-2b: Completed Phase III enrollment

AOP completed enrollment of >260 patients in the open-label, European Phase III PROUD-PV trial comparing 50-500 ug subcutaneous ropeginterferon alfa-2b every other week vs. oral hydroxyurea once daily or every other day for 1 year....
08:00 , Dec 17, 2012 |  BC Week In Review  |  Clinical News

PEG-P-INF alfa-2b: Phase I/II data

Data from 11 evaluable patients in the Phase II portion of the open-label, Austrian Phase I/II PEGINVERA trial showed that subcutaneous AOP2014 given every 2 weeks produced an ORR of 91% at 12 months, including...
02:12 , Dec 11, 2012 |  BC Extra  |  Clinical News

AOP Orphan reports Phase II polycythemia vera data

AOP Orphan Pharmaceuticals AG (Vienna, Austria) reported data from 11 evaluable patients in the Phase II portion of the Phase I/II PEGINVERA trial of its subcutaneous AOP2014 to treat polycythemia vera (PV). The compound produced...
07:00 , Jun 23, 2008 |  BC Week In Review  |  Clinical News

Pharmaessentia preclinical data

Four monkeys injected with P1101 peginterferon alfa-2b had detectable peginterferon levels after 2 weeks compared with 2 of 4 monkeys injected with marketed peginterferon. Pharmaessentia plans to submit an IND for P1101 to treat HBV...