As biotech and mid-sized pharma companies continue to drive growth for CROs (contract research organizations), the expected ramping up of prices due to increased competition has yet to fully materialize, experts say.
Testing the toxicity of drug candidates in animals is archaic and unreliable according to PETA, which joined preclinical CROs at SOT to put forward alternatives.
Global CRO Parexel has signed a definitive agreement to acquire privately-owned, Chandigarh, India-based Quantum Solutions India, a provider of specialized pharmacovigilance services.
Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.
Plus people on the move at CROs, genome companies, and medical device contract manufacturers.
Research tool supplier Horizon Discovery Group and ArcherDX, a supplier of Next Generation Sequencing (NGS) fusion detection, have signed an Original Equipment Manufacture (OEM) agreement that will see Horizon’s Reference Materials supplied as a standalone product alongside the Archer FusionPlex to aid customer validation of ALK fusion assay kits. ...
Parexel’s audits of Ranbaxy’s deficient manufacturing operations in India were of specific interest to the FDA, though the CRO did not turn over the reports because of concerns that their release might damage the confidentiality of the company’s audit program as a whole, according to court filings.