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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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News in brief

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.

PEOPLE ON THE MOVE

New roles for Genentech and Bristol-Myers Squibb veterans

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

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