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Academics urge updating WHO, ICH guidelines to ensure quality drugs used in clinical trials

The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from the WHO and ICH, academics contend in the British Medical Journal .

Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publically accessible database of clinical trial data does not do enough to make the data transparent. 

Senators reintroduce bill to offer CROs a share of R&D tax credit

Sens. Tom Carper (D-Del.) and Pat Toomey (R-Penn.) reintroduced a bill that would permanently allow CROs (contract research organizations) to capture a share of the R&D tax credit. 

India taking further steps to reform clinical trial industry

Fluctuations in regulations over the past few years have reduced the number of clinical trials run on the subcontinent, but now governing bodies are looking at new ways to attract trials and further control the industry.

Japanese companies acquire CMO KBI Biopharma

Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and Boulder, Colorado. 

Spotlight

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...

Parexel sees book-to-bill bounce back as GSK strategic partnership renewal bears fruit

Parexel sees book-to-bill bounce back as GSK strategic partnership renewal bears fruit

One quarter after announcing a disappointing book-to-bill ratio, CRO Parexel has now renewed its strategic partnership with...

AstraZeneca turns to CRISPR for drug discovery; Are you watching Cellectis?

AstraZeneca turns to CRISPR for drug discovery; Are you watching Cellectis?

AstraZeneca has partnered to use the CRISPR genome editing technique across its discovery programmes in a move...

HCV drugs Sovaldi and Olysio boost Q1 sales for AmeriSourceBergen

HCV drugs Sovaldi and Olysio boost Q1 sales for AmeriSourceBergen

New hepatitis C drugs produced by Gilead, Janssen and AbbVie contributed to a first quarter spike in...

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...

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