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Non-Approvable Letter

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August 20, 2019

The Sarepta fairy tale takes a worrying turn  

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?

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May 01, 2019

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. 

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January 18, 2019

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.

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November 05, 2018

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.

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October 18, 2018

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.

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September 19, 2018

The other shoe drops for Pharming

A US complete response letter leaves Ruconest at the mercy of rivals like Shire.

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August 28, 2018

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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June 22, 2018

Snippet roundup: Anika and Valeant feel the pain, but Novo scores another oral sema win

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May 10, 2018

Cosmo’s shares saved by no bell as FDA halts approval

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May 03, 2018

Biosimilar knockbacks expose increasing big pharma focus

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April 24, 2018

Olumiant’s US path made no clearer by adcom vote

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