New Drug Application

Aerie to build manufacturing facility in Ireland

Aerie to build manufacturing facility in Ireland

By Dani Bancroft

Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.

Relypsa selects DSM to manufacture API for hyperkalemia treatment

Relypsa selects DSM to manufacture API for hyperkalemia treatment

By Zachary Brennan

California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

Dispatches from DIA

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

By Zachary Brennan

The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.

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