No news equals bad news for Nabriva and Heron
Manufacturing issues prompt the US regulator to knock back projects from Nabriva and Heron Therapeutics, both of which insist that the problems are easily solvable.
US regulator wipes the smile off Immunomedics’ face
Issues with manufacturing, not exactly a new problem for Immunomedics, derail the company’s bid for glory.
US regulator sails into treacherous opioid waters
Public criticism fails to derail approval of Acelrx’s opioid painkiller, but not without a lengthy apologia from Scott Gottlieb.
Novartis quietly kicks the canakinumab can down the road
An expensive cardiovascular programme has proven a dead end, but the Swiss group is already looking towards cancer.
The other shoe drops for Pharming
A US complete response letter leaves Ruconest at the mercy of rivals like Shire.
Ionis feels the pain as the US FDA finally bares its teeth
A complete response letter for Waylivra has taken investors by surprise, and increases the pressure on Ionis before an FDA decision on Tegsedi.
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