BC Week In Review | Sep 20, 2010
Clinical News

Ablavar gadofosveset regulatory update

FDA said it will contraindicate 3 gadolinium-based MRI contrast agents in patients with acute kidney injury or chronic severe kidney disease: Magnevist gadopentetate dimeglumine, Omniscan gadodiamide and Optimark gadoversetamide. The move comes after the agency's...
BC Week In Review | Dec 14, 2009
Clinical News

Eovist gadoxetate disodium regulatory update

EMEA's CHMP concluded a review of gadolinium-based contrast agents used with MRI scans and issued recommendations regarding the risk of nephrogenic systemic fibrosis, a rare disorder causing a thickening of skin and connective tissues in...
BC Week In Review | Dec 14, 2009
Clinical News

Eovist gadoxetate disodium regulatory update

The committee's discussion focused primarily on the prospect of contraindicating those three products, but also discussed safety data for MultiHance gadobenate dimeglumine and ProHance gadoteridol from Bracco Diagnostics Inc. (Princeton, N.J.); Eovist gadoxetate disodium from...
BC Week In Review | Oct 12, 2009
Clinical News

Eovist gadoxetate disodium regulatory update

Bayer AG (Xetra:BAY), Leverkusen, Germany   Bracco Diagnostics Inc. , Princeton, N.J.   Covidien plc (NYSE:COV), Loughlinstown, Ireland   General Electric Co. (NYSE:GE), Fairfield, Conn.   Product: Eovist gadoxetate disodium; Magnevist gadopentetate dimeglumine; ProHance gadoteridol; MultiHance...
BC Week In Review | Oct 12, 2009
Clinical News

Ablavar gadofosveset trisodium regulatory update

Epix Pharmaceuticals Inc. (Pink:EPIX), Lexington, Mass.   Lantheus Medical Imaging Inc. , North Billerica, Mass.   Product: Ablavar gadofosveset trisodium ( MS-325 )   Business: Diagnostic   FDA's Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and...
BioCentury | Sep 29, 2008
Regulation

Acting on REMS

Acting on REMS Drug Company Med Guide/PPI Communication plan Elements to assure safe use 505(o) required postmarket study or trial NME approvals Cimzia certolizumab UCB (Euronext:UCB) P P Entereg alvimopan Adolor (NASDAQ:ADLR)/GlaxoSmithKline (LSE:GSK; NYSE:GSK) P...
BC Week In Review | Jul 14, 2008
Clinical News

Eovist gadoxetate disodium regulatory update

FDA approved an NDA from Bayer for IV Eovist gadoxetate for use in magnetic resonance imaging (MRI) of the liver in adult patients to provide contrast in the T1 weighted images to aid in the...
BioCentury | Jun 28, 2004
Strategy

Schering's core pipeline

Schering's core pipeline Product Indication Status Partner Women's healthcare Yasmin drospirenone low dose Oral contraceptive Registration Acne Ph III (registration 2005) Premenstrual dysphoric disorder (PMDD) Ph III (data 4Q04; registration 2005) Menostar transdermal ultra-low dose...
BC Week In Review | Oct 1, 2001
Company News

Epix Medical, Bracco Imaging S.p.A. diagnostics/imaging news

The parties settled disputes surrounding patents covering magnetic resonance imaging (MRI) contrast agents. Bracco received a worldwide non-exclusive, royalty-bearing license from EPIX to patents related to Bracco's Multihance contrast agent for MR imaging of the...
BC Week In Review | May 15, 2000
Company News

Epix Medical, Schering deal

Schering received a royalty-bearing license to European Patent No. 222,886 and U.S. Patents Nos. 4,899,755 and 4,880,008 covering MRI contrast agents. The patents are issued to Massachusetts General Hospital and licensed exclusively to EPIX. EPIX...
Items per page:
1 - 10 of 12