07:00 , Jul 16, 2012 |  BC Week In Review  |  Company News

Le Groupe Pharmaceutique Boivin, Recordati sales and marketing update

Le Groupe Pharmaceutique Boivin, Montreal, Quebec   Recordati S.p.A. (Milan:REC), Milan, Italy   Business: Pharmaceuticals   Recordati's Orphan Europe subsidiary granted Medunik Canada, a part of Le Group Pharmaceutique, exclusive rights in Canada to market and distribute four...
07:00 , Jun 6, 2011 |  BC Week In Review  |  Clinical News

Carbaglu carglumic acid regulatory update

The European Commission approved an expanded label for Recordati's Carbaglu carglumic acid to include the treatment of hyperammonemia due to isovaleric acidemia, methylmalonic acidemia and propionic acidemia. Carbaglu is approved in the U.S. and Europe...
07:00 , Apr 25, 2011 |  BC Week In Review  |  Clinical News

Carbaglu carglumic acid regulatory update

EMA's CHMP issued a positive opinion to extend the indication for Carbaglu carglumic acid from Recordati to include the treatment of hyperammonemia due to isovaleric acidemia, methylmalonic acidemia and propionic acidemia. Carbaglu is approved in...
07:00 , Mar 22, 2010 |  BC Week In Review  |  Clinical News

Carbaglu regulatory update

FDA approved an NDA from Recordati for Carbaglu carglumic acid to treat hyperammonemia due to hepatic enzyme N-acetylglutamate synthetase (NAGS) deficiency, an inherited disorder that causes ammonia to accumulate in the blood. Carbaglu has Orphan...
23:52 , Mar 18, 2010 |  BC Extra  |  Company News

FDA approves Carbaglu

FDA approved an NDA from Recordati S.p.A. (Milan:REC) for Carbaglu carglumic acid to treat hyperammonemia due to hepatic enzyme N-acetylglutamate synthetase (NAGS) deficiency, an inherited disorder that causes ammonia to accumulate in the blood....
08:00 , Jan 18, 2010 |  BC Week In Review  |  Clinical News

Carbaglu regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-0 that the risk-benefit profile of Carbaglu carglumic acid from Recordati supports its approval to treat hyperammonemia due to hepatic enzyme N-acetylglutamate synthetase (NAGS) deficiency, an inherited...
00:37 , Jan 14, 2010 |  BC Extra  |  Top Story

FDA panel backs Carbaglu

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-0 on Wednesday that the risk-benefit profile of Carbaglu carglumic acid from Recordati S.p.A. (Milan:REC) supports its approval to treat hyperammonemia due to hepatic enzyme N-acetylglutamate synthetase...
01:08 , Jan 12, 2010 |  BC Extra  |  Company News

FDA posts Carbaglu briefing documents

FDA posted briefing documents ahead of Wednesday's Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss an NDA from Recordati S.p.A. (Milan:REC) for Carbaglu carglumic acid to treat hyperammonemia due to hepatic enzyme N-acetylglutamate synthetase...
08:00 , Nov 23, 2009 |  BC Week In Review  |  Clinical News

Carbaglu regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Jan. 13 to discuss an NDA from Recordati for Carbaglu carglumic acid to treat hyperammonemia in patients with N-acetylglutamate synthetase (NAGS) deficiency, an inherited disorder...
02:12 , Nov 19, 2009 |  BC Extra  |  Company News

FDA panel to discuss Zavesca, Carbaglu

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Jan. 12 to discuss an sNDA from Actelion Ltd. (SIX:ATLN) for Zavesca miglustat to treat progressive neurological manifestations in patients with Niemann-Pick type C disease,...