Icon puts up record net new business wins in Q2
CRO (contract research organization) Icon reported its highest level of quarterly bookings ever on Tuesday and the company’s stock jumped by about 15%.
Archives for July 28, 2015
EMD Millipore and celares team to offer PEGylation to biologic makers
Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.
PRA acquires small clinical development software company for $2.5m
CRO (contract research organization) PRA Health Sciences reported in its earnings call on Tuesday that earlier in Q2 it acquired Value Health Solutions (VHS), a clinical development software company, for $2.5m.
FDA offers draft guidance on quality metrics used to assess drug manufacturing
New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.
'Rough notes' and backdated signatures land Indian API maker US FDA warning
Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.
TRIAL TRANSPARENCY
CRO vs HRA trial transparency case ends in a win for industry
A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September 2013.