07:00 , Oct 20, 2014 |  BC Week In Review  |  Clinical News

Sulfur hexafluoride lipid-type A microspheres regulatory update

FDA approved Lumason sulfur hexafluoride lipid-type A microspheres from Bracco as an ultrasound contrast agent. The product is indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve...
07:00 , Aug 12, 2013 |  BC Week In Review  |  Company News

Bracco Diagnostics, Emergent BioSolutions deal

Emergent completed its acquisition of the Healthcare Protective Products Division ( HPPD ) of Bracco's Bracco Diagnostics Inc. subsidiary for $26 million in cash up front, plus sales and development milestones (see BioCentury, May 13)....
07:00 , May 13, 2013 |  BC Week In Review  |  Company News

Bracco Diagnostics, Emergent BioSolutions deal

Emergent will acquire the Healthcare Protective Products Division ( HPPD ) of Bracco's Bracco Diagnostics Inc. subsidiary for $26 million in cash up front, plus sales and development milestones. The deal includes HPPD's marketed chemical...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Clinical News

Sonus regulatory update

The U.S. District Court for the District of Columbia lifted an injunction prohibiting the FDA from continuing any approval or review procedures for EchoGen, SNUS's ultrasound contrast agent for cardiology and radiology. The court issued...
08:00 , Jan 7, 2013 |  BC Week In Review  |  Company News

Advaxis management update

Advaxis Inc. (OTCBB:ADXS), North Brunswick, N.J.   Business: Cancer, Infectious   Hired: Daniel O'Connor as SVP, chief legal and business development officer, formerly VP and general counsel at Bracco Diagnostics Inc.  ...
07:00 , Aug 6, 2012 |  BC Week In Review  |  Clinical News

MultiHance gadobenate dimeglumine regulatory update

Bracco said FDA approved MultiHance gadobenate dimeglumine injection for use in magnetic resonance angiography ( MRA ) imaging to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. The gadolinium-based contrast agent...
08:00 , Feb 27, 2012 |  BC Week In Review  |  Clinical News

CardioGen-82 regulatory update

FDA approved an updated label for Bracco's CardioGen-82 to include a black box warning on unintended exposure to strontium-82 and strontium-85 radiation. The updated label also includes new "Alert Limits" for strontium-82 and strontium-85 levels...
00:03 , Apr 7, 2011 |  BC Extra  |  Politics & Policy

FDA panel to discuss ultrasound contrast agents

FDA's Cardiovascular and Renal Drugs and Drug Safety and Risk Management advisory committees will meet on May 2 to discuss the safety of ultrasound contrast agents. The committees will discuss two marketed contrast agents, Definity...
08:00 , Dec 14, 2009 |  BC Week In Review  |  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...
08:00 , Dec 14, 2009 |  BC Week In Review  |  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...