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news.FDA accepts Takeda’s alogliptin NDA, says PPD
PPD partnered with Takeda to develop the compound. Under PPD’s agreement with Takeda, the FDA’s acceptance of the NDA filing triggers a $15 million milestone payment to PPD.
PPD partnered with Takeda to develop the compound. Under PPD’s agreement with Takeda, the FDA’s acceptance of the NDA filing triggers a $15 million milestone payment to PPD.
In January 2007, Solvay has licensed the right to market Luvox CR extended-release capsules and Luvox immediate-release tablets to Jazz Pharmaceuticals in the US. The license agreement provides
Embeda combines an extended release opioid agonist with sequestered naltrexone, an opioid antagonist. In clinical trials, when Embeda was taken as directed, it provided pain relief and the
The positive ruling protects P&G’s rights in the US to exclusively market the osteoporosis therapy Actonel. On August 13, 2004 P&G filed a patent infringement lawsuit against Teva
The company will begin distribution of the product immediately. Irinotecan hydrochloride injection, the generic equivalent to Pfizer’s Camptosar will be available in 40mg/2mL and 100mg/5mL sizes. Doug Boothe,
Under the terms of the agreement, Abbott will have exclusive rights to distribute Luminex’s new xTAG Respiratory Viral Panel (RVP) worldwide outside the US and semi-exclusive rights in
In August, 2007 the Department of Health has announced that it would be re-negotiating the PPRS, even though the current five-year agreement had only been in place for
Wyeth terminated the collaboration with Solvay after assessing the opportunity for bifeprunox and determining it would not have sufficient commercial value for the two companies to share. All
This TGA submission has been based on the market authorization application with the European Medicines Agency and the biological license application with the FDA, submitted in December 2007.
Ramelteon was approved by the FDA in July 2005 as the first and only prescription sleep medication, classified non-controlled substance, showing no evidence of abuse and dependence. It