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Promethera's Cell Therapy Attracts Corporate VCs To Largest European Biopharma Funding Round This Year

 
• By John Davis

Belgium's Promethera raises $31.4 million to start clinical trials of its cell therapy for orphan liver diseases in a Series B funding

The Belgian cell therapy company, Promethera Biosciences SA NV, has raised €23.6 million ($31.4 million) to support the start of clinical trials of its progenitor hepatocyte product, Promethera HepaStem, in orphan liver diseases, with the corporate venture funds of Shire PLC and Boehringer Ingelheim Corp. becoming investors for the first time.

Other new investors in the Series B financing round, led by existing investor , include Mitsui Global Investment, the Danbury,...

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New EU Filings

 
• By Neena Brizmohun

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Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 
• By Eliza Slawther

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

More from Geography

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 
• By Francesca Bruce

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 
• By Eliza Slawther

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.