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Two FDA advisory committees voted 16-8 on Thursday against recommending pediatric labeling for Endo Pharma’s Opana IR (immediate-release oxymorphone). Read More
Gottlieb is “an ideal partner” in the company’s “work to help define RWE's role in the development, delivery, and payment of treatments,” said Aetion CEO Carolyn Magill. Read More
Combining the drug portfolios of the merging companies “may give them increased negotiating leverage to force buyers to provide them with more favorable terms across multiple product categories,” the senators said. Read More
The agency will grant a meeting if it concerns a product for which there is no product-specific guidance or an “alternative equivalence evaluation.” Read More