All news articles for June 2015

The US Patent and Trademark Office and case law have created confusion around IP

Sequenom case leaves pharma confused over patent law

By Fiona BARRY

US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer. 

ICH clarifies Q7 guidance on API GMP manufacturing

ICH clarifies Q7 guidance on API GMP manufacturing

By Zachary Brennan

In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices)...

Salt

US FDA publishes API-salt naming policy

By Gareth MACDONALD

Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).

UK National Biologics Manufacturing Centre in Darlington

Small-scale will be the next big thing says UK’s CPI

By Gareth MACDONALD

Small-scale production techs will dominate biopharma says the UK organisation tasked with developing the £20m “biologics factory of the future” and the £38m National Biologics Manufacturing Centre in Darlington.