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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