PE group Water Street sets up contract pharma services unit aimed at generic drugmakers
Water Street Healthcare Partners has set up a contract services firm to make products for an unnamed generic drugmaker.
Archives for May 31, 2015
FDA draft guidance seeks to address ‘lack of clarity’ around CMC changes
The new draft guidance from the US FDA seeks to address the lack of clarity around when new chemistry, manufacturing, and controls (CMC) information must be reported to the agency.
Pediatric trials in EU increase as overall trials decline, Commission report says
The proportion of pediatric trials of all clinical trials in the EU continues to increase since the integration of a Pediatric regulation in 2007, despite a decrease in the number of clinical trials overall since then, according to a new report from the...
Ex-Sanofi site offering manufacturing space for SME pharma in London
An ex-Sanofi site in the UK has been redeveloped to offer start-up and small pharma access to manufacturing space.
Indian industry group calls for clearer expiry date labelling rules for topic drugs
The DCGI needs to clarify expiry date labelling rules for topical drugs according to an Indian trade group, which says some members’ products are being deemed to be ‘misbranded.’
WHO asked to probe vaccine prices and competitive landscape
The WHO has yet to decide how to investigate if barriers to competition are preventing vaccine price cuts after World Health Assembly members committed to probe the jabs industry.
Bio-Rad entangled in another lawsuit over foreign bribery
The former general counsel of Bio-Rad Technologies sued the research company in California federal court last week, claiming he was illegally fired in 2013 after he blew the whistle on the company’s bribery in China.
Eurofins to buy diagnostic PCR specialist for $50m
Eurofins Scientific has agreed to buy diagnostic testing services firm Diatherix Laboratories for $50m (EUR55m).