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FDA advisers voted 8–4 Thursday in support of approval for Novo Nordisk’s ultra-long acting insulin candidates Tresiba and Ryzodeg for Type 1 and Type 2 diabetes despite lingering worries about cardiovascular effects.
Citing cardiovascular safety concerns, the FDA says Salix Pharmaceuticals must conduct a large, well-controlled, chronic administration trial if its sNDA for opioid-induced constipation (OIC) drug Relistor is to advance.
As Novartis begins to stare down a patent cliff, the industry’s biggest spender on R&D is now projecting at least 14 blockbusters by 2017.
Drugmakers are locating pediatric clinical trials in the U.S. more often now than they did five years ago, a new study finds.
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