BioCentury | Nov 5, 2012
Clinical News

Sonazoid perflubutane: Development discontinued

...6 months of its fiscal year ending March 31, 2013, that it discontinued development of perflubutane...
...Fairfield, Conn. Product: Sonazoid perflubutane ( DD-723-B ) Business: Diagnostic Molecular target: NA Description: IV perflubutane-based...
BioCentury | Aug 20, 2012
Clinical News

Sonazoid perflubutane regulatory update

...expanded label for Sonazoid perflubutane to include ultrasound imaging of focal breast lesions. The IV perflubutane-based...
...Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568), Tokyo, Japan General Electric Co. (NYSE:GE), Fairfield, Conn. Product: Sonazoid perflubutane...
BioCentury | Jul 23, 2012
Clinical News

Imagify perflubutane regulatory update

...Acusphere said it completed an MAA dossier for Imagify perflubutane polymer microspheres to detect coronary artery...
...required for approval (see BioCentury, March 16, 2009). Acusphere Inc. (Pink:ACUSD), Lexington, Mass. Product: Imagify perflubutane...
BioCentury | Jul 4, 2011
Finance

3Q Financial Markets Preview: Flavored with Phase III

...Industries Ltd. (NASDAQ:TEVA) Laquinimod Multiple sclerosis (MS) Ph III data 3Q11 Acusphere Inc. (Pink:ACUS) Imagify perflubutane...
BioCentury | Jun 13, 2011
Clinical News

Imagify perflubutane: SPA received

...received an SPA from FDA for a planned placebo-controlled Phase III trial to evaluate Imagify perflubutane...
...to begin the trial. In 2009, Acusphere received a complete response letter from FDA for Imagify...
...required for approval (see BioCentury, March 16, 2009). Acusphere Inc. (Pink:ACUS), Tewksbury, Mass. Product: Imagify perflubutane...
BioCentury | Apr 13, 2009
Company News

Acusphere, Nycomed Group A/S deal

...partners terminated a 2004 deal granting Nycomed exclusive rights to develop and commercialize Acusphere's Imagify perflubutane...
...an MAA for Imagify. In March, Acusphere received a complete response letter from FDA for Imagify...
BioCentury | Mar 16, 2009
Finance

Ebb & Flow

...after the company received a complete response letter from FDA for an NDA for Imagify perflubutane...
BioCentury | Mar 16, 2009
Clinical News

Imagify perflubutane regulatory update

...Acusphere received a complete response letter from FDA for an NDA for Imagify perflubutane as an...
...BioCentury, Dec. 12, 2008). In February, Acusphere amended the NDA to limit the indication of Imagify...
...12, 2004). Acusphere Inc. (Pink:ACUS), Watertown, Mass. Nycomed Group A/S , Zurich, Switzerland Product: Imagify perflubutane...
BioCentury | Mar 9, 2009
Company News

Acusphere diagnostic news

...when the company announced cost-cutting measures and submitted an amendment to its NDA for Imagify perflubutane...
BioCentury | Feb 23, 2009
Company News

Acusphere, Bayer, General Electric deal

...the company can fund operations beyond the anticipated May 31 PDUFA date for its Imagify perflubutane...
...operating loss of $34.8 million. Instead of paying GE $4.6 million upon the earlier of Imagify's...
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