A week after one Bristol-Myers Squibb approval decision was delayed a second suffers a similar fate, and the group’s CVR slowly unravels.
On the corporate front Astellas continued to buy, while Qiagen decided that it was not, after all, up for sale.
A complete response letter for Sarepta’s follow-on Duchenne therapy is a big blow for the company, but in hindsight was the FDA’s decision actually that surprising?
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.
Issues with manufacturing, not exactly a new problem for Immunomedics, derail the company’s bid for glory.
Public criticism fails to derail approval of Acelrx’s opioid painkiller, but not without a lengthy apologia from Scott Gottlieb.
An expensive cardiovascular programme has proven a dead end, but the Swiss group is already looking towards cancer.
A US complete response letter leaves Ruconest at the mercy of rivals like Shire.
A complete response letter for Waylivra has taken investors by surprise, and increases the pressure on Ionis before an FDA decision on Tegsedi.