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European Notebook: Clinical Trial Fatality; Affordable Medicines Debate; Physician Payment Disclosure

 
• By John Davis

One death and five healthy volunteers hospitalized in a Phase I study in France; EU Council looks set to debate patient access to medicines; and the two Mercks set to continue litigation in Europe and the US over use of the Merck word, straining their 60-year-old agreement. Generics/biosimilar trade group adopts physician payment disclosure policy.

2016 began with some tragic news in Europe, the death of one volunteer and severe adverse reactions in five others in a clinical trial being conducted in France. The Phase I study was being conducted by local company Biotrial on behalf of Portugal’s Bial-Portela & CA SA, and involved an investigational drug BIA-10-2474 being developed for CNS indications.

The last drug trial disaster in Europe was back in 2006 in the UK, and led to a tightening of...

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England Prioritizes SGLT-2s & GLP-1s In Diabetes Market Access ‘Shake Up’

 
• By Neena Brizmohun

Recommendations from the health technology assessment institute, NICE, reflect a strategic shift from treating type 2 diabetes to proactively preventing future complications of the condition.

UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments

 
• By Vibha Sharma

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‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

More from Geography

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

Zimbabwe Tackles Medicines Falsification With New Requirements For Pharma

 
• By Neena Brizmohun

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.