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Drug Safety

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Latest From Drug Safety

Europe Restricts Cyproterone Use Due To Meningioma Risk; Companies To Conduct Studies

The risk of developing meningioma with cyproterone-containing medicines is rare, but it is serious enough to merit restrictions on how such products are used, according to the European Medicines Agency.

Europe Drug Safety

FDA Requests Belviq Be Pulled From The US Market Due To Cancer Risk

The agency requested the weight loss pill be voluntarily recalled by Eisai, the death knell for a trio of obesity drugs that launched early in the last decade. 
Metabolic Disorders Drug Safety

UK MHRA Looks Beyond Brexit Transition

Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.

Brexit Regulation

‘Abuse-Deterrent’ Opioids May Be Headed For A Terminology Change

US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.

Advisory Committees Drug Safety

Sanofi Faces Charges Over Valproate Birth Defects

In a case that has parallels with that of Servier’s diabetes drug Mediator, Sanofi has been indicted over its alleged lack of transparency over the birth defects associated with use of its valproate drug in pregnant women.

France Drug Safety

EU Regulatory System Attacked Over Quality Of Approvals

If anyone can throw cold water on the claimed benefits of some of Europe's most recently approved medicines, it’s the international drug bulletin, Prescrire. In an assessment of 108 of the pharma industry’s latest offerings, it gives a cautious welcome to some but says that more than half bring nothing new and others could even be dangerous to patients.

Europe Drug Approval Standards

Adverse Events For Generic Of GSK's Advair Diskus On US FDA’s Radar

As patients log device complaints for Mylan’s Advair Diskus generic Wixela Inhub, the agency is assessing whether additional reminders about the products’ differences are needed.

Generic Drugs Safety

US FDA Seeks Withdrawal Of Injectable Bacitracin Despite Extensive Off-Label Use

Injectable bacitracin, often used as a surgical irrigant, carries serious risks of nephrotoxicity and anaphylaxis; product is no longer prescribed for its lone approved indication in pediatric pneumonia. FDA’s decision aligns with advisory committee recommendations in 1984 and 2019.

 

Drug Safety Generic Drugs

Guido Rasi - The Face Of The EMA For A Decade

The head of the European Medicines Agency is nearing the end of his tenure. We consider Guido Rasi’s achievements over the past 10 years as well as the controversies that have arisen under his leadership – and report that sailing is likely to figure in his plans for life after the agency.

 

Europe Regulation
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