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Takeda/Shire Merger: Five Things To Worry About

 
• By Bridget Silverman

From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.

Ladder

The merger of Shire PLC and Takeda Pharmaceutical Co. Ltd., positions the combined firm to join the ranks of the top 10 pharmaceutical firms – and will bring with it the attendant pressures on reviews and approvals.

The companies said the transformative tie-up – effectively a merger given Shire's larger size and current market cap – will...

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EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
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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.

New EU Filings

 
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Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Recent And Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

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• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
• By Derrick Gingery

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Recent And Upcoming FDA Advisory Committee Meetings

 
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