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...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
19:55 , Nov 6, 2017 |  BC Innovations  |  Distillery Therapeutics

Cardiovascular

INDICATION: Heart failure Cell culture and mouse studies suggest GHRH receptor agonists could help treat heart failure. In a rat cardiomyoblast cell line, primary rat ventricular myocytes and human induced pluripotent stem (iPS) cell-derived cardiomyocyte...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
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 , Sep 14, 2015 |  BC Week In Review  |  Company News

Theratechnologies, AOP Orphan sales and marketing update

Egrifta tesamorelin to treat lipodystrophy in HIV patients is now available in European countries as part of a named-patient program. The analog of growth hormone-releasing factor is available in the U.S. and Canada. Earlier this...
07:00 , Jul 13, 2015 |  BC Week In Review  |  Clinical News

Tetmodis tetrabenazine regulatory update

AOP Orphan submitted a regulatory application for Tetmodis tetrabenazine under the EU’s decentralized procedure to treat tardive dyskinesia. The U.K. is the reference member state. The small molecule selective inhibitor of vesicular monoamine transporter 2...
07:00 , May 18, 2015 |  BC Week In Review  |  Company News

AOP Orphan, Cardiome deal

AOP Orphan granted Cardiome rights to market IV and powder formulations of Esmocard esmolol in Italy, France, Spain and Belgium. The small molecule adrenergic receptor beta 1 ( ADRB1 ) antagonist is approved to treat...