...Oceana launched Solesta in the U.S. in September. Salix believes peak-year sales for the injectable hyaluronic... ...will acquire Oceana for $300 million in cash. Salix will gain Oceana's two marketed products: Solesta...
...Inc. (Edison, N.J.) for $300 million in cash. Salix will gain Oceana's two marketed products: Solesta... ...risk of overt hepatic encephalopathy (HE) recurrence in patients with advanced liver disease. Oceana launched Solesta...
...Oceana launched Solesta in the U.S. to treat fecal incontinence. The average wholesale price is $4,428... ...acid biocompatible from Q-Med AB which was acquired by Galderma S.A. (Lausanne, Switzerland) in March. Solesta...
...FDA approved a PMA from Oceana for Solesta to treat fecal incontinence. Oceana previously said it... ...incontinence. Oceana previously said it will conduct a post-approval study to evaluate long-term treatment of Solesta... ...December, an FDA advisory committee voted 5-0, with 1 abstention, that the benefit-risk profile of Solesta...
...FDA approved a PMA from Oceana Therapeutics Inc. (Edison, N.J.) for Solesta to treat fecal incontinence... ...has exclusive, worldwide rights to the injectable hyaluronic acid biocompatible from Q-Med AB (Uppsala, Sweden). Solesta...
...FDA issued an approvable letter for a PMA from Oceana for Solesta to treat fecal incontinence... ...biotech added that it will also conduct a post-approval study to evaluate long-term treatment of Solesta... ...December, an FDA advisory committee voted 5-0, with 1 abstention, that the benefit-risk profile of Solesta...
...FDA issued an approvable letter for a PMA from Oceana Therapeutics Inc. (Edison, N.J.) for Solesta... ...biotech added that it will also conduct a post-approval study to evaluate long-term treatment of Solesta... ...December, an FDA advisory committee voted 5-0, with 1 abstention, that the benefit-risk profile of Solesta...
...A double-blind, international pivotal trial in 206 patients showed that transanal submucosal injections of Solesta met... ...were eligible to receive open-label Solesta. Data were published in The Lancet. A PMA for Solesta... ...2010). Oceana has exclusive, worldwide rights to Solesta from Q-Med (see BioCentury, April 27, 2009. Solesta...
...the Medical Devices Advisory Committee voted 5-0, with 1 abstention, that the benefit-risk profile of Solesta... ...adult patients who have failed conservative therapy. The panel also voted 6-0 and 5-1 that Solesta... ...worldwide rights to the injectable hyaluronic acid biocompatible from Q-Med (see BioCentury, April 27, 2009). Solesta...