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UK MHRA Issues Landmark Infringement Notice To Celixir Over Serious Clinical Trial Violations

 
• By Eliza Slawther

The UK’s drug regulator said that a trial run by cell therapy firm Celixir “risked seriously jeopardizing the rights, safety and wellbeing of trial participants” after an inspection discovered expired product batches, unauthorized dosing and other serious breaches.

Compliance
• Source: Shutterstock

Celixir, a British regenerative medicine company formerly known as Cell Therapy Ltd, was handed a first-of-its-kind infringement notice by the UK’s drug regulator, the MHRA, after it failed to comply with a multitude of good clinical practice (GCP) regulations.

Key Takeaways 

  • An MHRA investigation of a clinical trial being run by Celixir revealed nine major and three serious findings in relation to good clinical practice principles.

The notice, published on 17 July, dated back to a 2020 GCP inspection of a trial sponsored by Celixir. Although...

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EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

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More from Geography

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 
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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.