GSK’s Imigran Recovery Is First Triptan Approved For Nonprescription UK Sale

GlaxoSmithKline expects to make nonprescription Imigran Recovery (sumatriptan 50 mg) available in the UK in mid-June following approval for pharmacy sale by the Medicines & Healthcare products Regulatory Agency

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Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.