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Regulatory & Safety: Top Headlines

FDA opts for four-letter suffix to distinguish biologics and biosimilars

FDA is calling on commenst for the next 60 days on its drft biological product naming guidance

28-Aug-2015 - The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.

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MHRA uncovers $1m illegal ED drug haul

27-Aug-2015 - A UK man has been sentenced to 16 months in prison for smuggling illegal erectile dysfunction drugs following an MHRA investigation.

Europe, US, Japan: The recall round-up

27-Aug-2015 - Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.

MHRA launches fees calculator

26-Aug-2015 - The UK regulator is launching a calculator to help pharma companies calculate the fees for drug applications.

MHLW urges Japan's generics sector to consolidate

26-Aug-2015 - The Japanese Government says consolidation of the country’s generics sector is needed to secure supplies.

‘Sheer ridiculousness’ or fair play? USPTO turns down patent challenge

25-Aug-2015 - The US Patent and Trademark Office has refused to review a challenge to Acorda Therapeutics’ patents from a group trying to block “abusive” IP claims.

Pfizer’s $17bn Hospira deal set to close in September after US FTC clearance

24-Aug-2015 - Pfizer has received the final regulatory clearances to acquire Hospira but the US FTC says it must divests four sterile injectable products.


New roles for Genentech and Bristol-Myers Squibb veterans

24-Aug-2015 - The latest promotions in's weekly round-up.

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