Draft guidance stresses need for quality in development of gene therapies
The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.
Archives for May 24, 2015
EMA re-confirms drug suspensions due to faulty trial data from GVK Biosciences
Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK...
CROs look to buttress research models businesses with CRISPR/Cas tech
As the largest pharma and tech suppliers – from Novartis to GE Healthcare to Thermo Fisher – begin exploring the world of CRISPR/Cas gene editing technology, contract research organizations are also looking into the new tech to explore ways to help...
Quintiles maintains 'outperform' rating following recent flurry of activity
A recent spate of activity - including the acquisition of a Japanese CRO and a secondary equity offering - has boosted Quintiles’ investment appeal, an analyst says.