WHO proposes central registry on human genome editing research

On the heels of the Chinese CRISPR scandal, stakeholders in the genome editing industry will be consulted to create standards for future research

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Verona gets EU patent for ensifentrine formulation extended to 2035

Drug by the British company is in Phase 2b clinical trials for chronic obstructive pulmonary disease

CluePoint champions risk-based study execution

Increased operational efficiency, lower costs and reduced regulatory submission risk are all part of the touted ...

WuXi STA Shanghai site passes GMP inspection by Europe's MPA

The drug product manufacturing facility is located in Waigaoqiao Free Trade Zone

The recurring insanity of labelling recall — and how to avoid it

We’re all familiar with Einstein’s alleged definition of insanity: doing the same thing over and over and expecting ...

WuXi PharmaTech subsidiaries hit regulatory and manufacturing milestone

Big moves at the pharma giant this week include WuXi Biologics becoming the first biologics company in China to be ...

Brexit update: UK Inspection Reports and GMP Certificates

The ECA Academy sheds light on the latest Brexit guidance documents released by the European Medicines Agency

Global serialisation: Russian track and trace readiness

Christoph Krähenbühl, Senior Director of Excellis Europe, explains the challenge that the new Russian traceability ...

Cyborg technology draws FDA attention

The US agency has drafted a preliminary guidance document for Brain-Computer Interface devices in a push to safely ...

Johnson & Johnson’s asbestos woes continue

The US Justice Department will be investigating claims that the healthcare giant sold asbestos contaminated talc

Safer water for future generations

Dr Mikael Khan, Chief Technology Officer at Arvia Technology, a provider of advanced tertiary water and wastewater ...

Rare diseases: understanding the patient journey

In the shadow of Rare Disease Day on 28 February 2019, Dr Kevin Robinson met with Zizi Imatorbhebhe, Senior Director of ...

GxP: The 5 Ps of Good Practice

The FDA guidelines are complex to interpret and difficult to put into practice. Governance service provider Qualsys ...

Beximco Pharma gets eight ANDAs from Sandoz

Deal with Novartis' division to boost Beximco's export sales to the US

EMA completes pre-approval inspection at WuXi Biologics

The European Medicines Agency has examined cGMP facilities for the production of Trogarzo