Archives for April 13, 2014

USCC: making sure Chinese APIs are safe is “hopeless task” for US FDA

Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.

Shift to CMO strategic alliances key to UK plant turnaround, says Patheon

Strategic alliances and speciality manufacturing have transformed the fortunes of a Patheon UK facility, the company says.

Karyopharm Therapeutics selects CRO Clinipace as preferred provider

Karyopharm Therapeutics has selected CRO Clinipace to help discover first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, 

UPDATE

Sugar in place of APIs discovered in EU's largest fake drug seizure

Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.

EMA requests more stability data for some manufacturing changes

Drugmakers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to a new EMA (European Medicines Agency) guideline.

CROs to 'push' patients into trials using partners, report predicts

Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts a drive to ‘push’ patients into trials, industry disagrees.

Broad Institute to sequence genomes for Pfizer-EMD Lupus research

The Broad Institute in Massachusetts, US will provide computational modelling support for a joint research project between Pfizer and EMD Serono profiling the genomes of lupus patients.