Competition in the notoriously tight-lipped CRO (contract research organization) and CMO (contract manufacturing organization) industries is getting fiercer as outsourcing picks up, though that hasn’t stopped one Chinese company from revealing who it...
The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.
Following its three acquisitions over the last year, AMRI is now looking to extend its footprint into India further with the acquisition of a FDA-approved API site, William Marth, president and CEO of AMRI, told attendees at the Barclays Global Healthcare...
Higher capacity utilization is improving prices across the non-clinical research sector according to Huntingdon Life Sciences CEO Brian Cass, who told Outsourcing-pharma.com the preclinical CRO may add scale to US operations.
Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.
Cromos Pharma has launched a free or reduced cost trial model to help small and mid-sized drugmakers overcome the funding Catch-22 that can derail development efforts.
GVK Biosciences has called marketing authorisation withdrawals by various European regulators “disproportionate,” arguing that ECG results at centre of data manipulation investigation have no bearing on safety.
Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.
CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials without compromising safety.