BC Week In Review | Nov 25, 2013
Clinical News

Deflux hyaluronic acid/dextranomer regulatory update

FDA approved a PMA supplement for Deflux hyaluronic acid/dextranomer from Salix to include 2 additional injection techniques - single intra-ureteric injection and a double intra-ureteric injection - to treat children with vesicoureteral reflux grades II-IV, a malformation...
BC Week In Review | Dec 10, 2012
Company News

Galderma, Ipsen sales and marketing update

Ipsen and Galderma renewed and amended a 2007 deal to commercialize Ipsen's Dysport abobotulinumtoxinA for aesthetic and dermatological use. Galderma will continue to commercialize the product in Brazil and Argentina and will now also exclusively...
BC Week In Review | Sep 24, 2012
Financial News

OxThera completes venture financing

OxThera AB , Uppsala, Sweden   Business: Endocrine/Metabolic   Date completed: 9/19/12   Type: Venture financing   Raised: SEK39 million ($5.9 million)   Investors: HealthCap; Industrifonden; Q-Med  ...
BC Innovations | Dec 8, 2011
Targets & Mechanisms

Proteasome DUBstep

Karolinska Institute researchers have identified a small molecule proteasome inhibitor for cancer that has a distinct mechanism from other compounds in the class. 1 Vivolux AB has licensed the candidate, which blocks two proteasome-associated deubiquitinating...
BC Week In Review | Sep 12, 2011
Company News

Oceana sales and marketing update

Oceana launched Solesta in the U.S. to treat fecal incontinence. The average wholesale price is $4,428 per kit. FDA approved a PMA from Oceana for the indication in May (see BioCentury, May, 30). Oceana has...
BC Week In Review | May 30, 2011
Clinical News

Solesta regulatory update

FDA approved a PMA from Oceana for Solesta to treat fecal incontinence. Oceana previously said it will conduct a post-approval study to evaluate long-term treatment of Solesta. In December, an FDA advisory committee voted 5-0,...
BC Extra | May 27, 2011
Company News

FDA approves Solesta

FDA approved a PMA from Oceana Therapeutics Inc. (Edison, N.J.) for Solesta to treat fecal incontinence. Oceana has exclusive, worldwide rights to the injectable hyaluronic acid biocompatible from Q-Med AB (Uppsala, Sweden). Solesta is already...
BC Week In Review | May 23, 2011
Company News

Dr. Reddy's, Oceana sales and marketing update

Oceana granted Dr. Reddy's exclusive Indian commercialization rights for genitourinary compound Deflux. The gel of 50 mg/mL dextranomer microspheres in a carrier gel of non-animal 15 mg/mL stabilized hyaluronic acid (HA) is injected submucosally in...
BC Week In Review | Apr 11, 2011
Clinical News

Solesta regulatory update

FDA issued an approvable letter for a PMA from Oceana for Solesta to treat fecal incontinence. According to Oceana, FDA made requests related to labeling and manufacturing requirements. The biotech added that it will also...
BC Extra | Apr 8, 2011
Company News

Approvable letter for Oceana's Solesta

FDA issued an approvable letter for a PMA from Oceana Therapeutics Inc. (Edison, N.J.) for Solesta to treat fecal incontinence. According to Oceana, FDA made requests related to labeling and manufacturing requirements. The biotech added...
Items per page:
1 - 10 of 40
BC Week In Review | Nov 25, 2013
Clinical News

Deflux hyaluronic acid/dextranomer regulatory update

FDA approved a PMA supplement for Deflux hyaluronic acid/dextranomer from Salix to include 2 additional injection techniques - single intra-ureteric injection and a double intra-ureteric injection - to treat children with vesicoureteral reflux grades II-IV, a malformation...
BC Week In Review | Dec 10, 2012
Company News

Galderma, Ipsen sales and marketing update

Ipsen and Galderma renewed and amended a 2007 deal to commercialize Ipsen's Dysport abobotulinumtoxinA for aesthetic and dermatological use. Galderma will continue to commercialize the product in Brazil and Argentina and will now also exclusively...
BC Week In Review | Sep 24, 2012
Financial News

OxThera completes venture financing

OxThera AB , Uppsala, Sweden   Business: Endocrine/Metabolic   Date completed: 9/19/12   Type: Venture financing   Raised: SEK39 million ($5.9 million)   Investors: HealthCap; Industrifonden; Q-Med  ...
BC Innovations | Dec 8, 2011
Targets & Mechanisms

Proteasome DUBstep

Karolinska Institute researchers have identified a small molecule proteasome inhibitor for cancer that has a distinct mechanism from other compounds in the class. 1 Vivolux AB has licensed the candidate, which blocks two proteasome-associated deubiquitinating...
BC Week In Review | Sep 12, 2011
Company News

Oceana sales and marketing update

Oceana launched Solesta in the U.S. to treat fecal incontinence. The average wholesale price is $4,428 per kit. FDA approved a PMA from Oceana for the indication in May (see BioCentury, May, 30). Oceana has...
BC Week In Review | May 30, 2011
Clinical News

Solesta regulatory update

FDA approved a PMA from Oceana for Solesta to treat fecal incontinence. Oceana previously said it will conduct a post-approval study to evaluate long-term treatment of Solesta. In December, an FDA advisory committee voted 5-0,...
BC Extra | May 27, 2011
Company News

FDA approves Solesta

FDA approved a PMA from Oceana Therapeutics Inc. (Edison, N.J.) for Solesta to treat fecal incontinence. Oceana has exclusive, worldwide rights to the injectable hyaluronic acid biocompatible from Q-Med AB (Uppsala, Sweden). Solesta is already...
BC Week In Review | May 23, 2011
Company News

Dr. Reddy's, Oceana sales and marketing update

Oceana granted Dr. Reddy's exclusive Indian commercialization rights for genitourinary compound Deflux. The gel of 50 mg/mL dextranomer microspheres in a carrier gel of non-animal 15 mg/mL stabilized hyaluronic acid (HA) is injected submucosally in...
BC Week In Review | Apr 11, 2011
Clinical News

Solesta regulatory update

FDA issued an approvable letter for a PMA from Oceana for Solesta to treat fecal incontinence. According to Oceana, FDA made requests related to labeling and manufacturing requirements. The biotech added that it will also...
BC Extra | Apr 8, 2011
Company News

Approvable letter for Oceana's Solesta

FDA issued an approvable letter for a PMA from Oceana Therapeutics Inc. (Edison, N.J.) for Solesta to treat fecal incontinence. According to Oceana, FDA made requests related to labeling and manufacturing requirements. The biotech added...
Items per page:
1 - 10 of 40