News & Analysis on Clinical Trial Services & Contract Research And Development
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 of the...
Medidata will provide metrics and analytics help to industry group TransCelerate to answer questions on the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites.
Amid ongoing efforts by the US FDA to crack down on foreign suppliers not meeting cGMP (current good manufacturing) requirements, India-based Sun Pharma is the latest company to be hit with a warning letter.
API manufacturers are gearing up for changes to regulations on elemental impurities made by the US Pharmaceopeia (USP).