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Breaking News on Contract Research, Manufacturing & Clinical Trials

Top Headlines

CRO pricing power remains ‘elusive,’ analyst says

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.

PETA joins preclinical CROs at SOT to promote animal testing alternatives

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.

Parexel to tap additional pharmacovigilance services with QSI acquisition

Global CRO Parexel has signed a definitive agreement to acquire privately-owned, Chandigarh, India-based Quantum Solutions India, a provider of specialized pharmacovigilance services. 

‘Game changer’: latest GDP rules spell full traceability for APIs

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.

PEOPLE ON THE MOVE

Ex-ICON director joins imaging services company

Plus people on the move at CROs, genome companies, and medical device contract manufacturers.

Horizon partners with ArcherDX to meet growing demand in the translational sequencing market

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 audit reports come under scrutiny thanks to Ranbaxy’s FDA lawsuit

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.

Spotlight

Outsourcing market’s recently IPO'd stock prices see early spike

Outsourcing market’s recently IPO'd stock prices see early spike

Between May 2013, when Quintiles went public , and this week, newly public companies’ stocks in the biopharma...

US FDA working to make clinical trials less wasteful

US FDA working to make clinical trials less wasteful

The US FDA is looking to set up master protocols that can continuously run and help cut...

Researchers enthusiastic over Obama’s new $215m precision medicine initiative

Researchers enthusiastic over Obama’s new $215m precision medicine initiative

In what was largely a pep rally for science, President Obama on Friday unveiled his $215m precision...

Strong USD to hit revenues but strategic CROs may see lower costs

Strong US Dollar to hit revenues but strategic CROs may see lower costs

The strengthening US Dollar will reduce CRO revenues, say analysts, but firms which have global strategic deals...

Biosimulation – the next step in PK modelling embraced by regulators

Biosimulation – the next step in PK modelling embraced by regulators

Computer-based drug modelling is moving from a discovery aid to a clinical tool accepted by regulators, according...