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Potential Blockbuster Lebrikizumab Among Latest Drugs Up For Decision On EU Approval

 
• By Neena Brizmohun

The European Medicines Agency  is set to decide whether to back EU marketing approval for eight new drugs.

A new batch of medicines could be approved in the EU soon • Source: Shutterstock

Eli Lilly/Almirall could this week learn whether the European Medicines Agency will recommend in favor of pan-EU marketing approval for lebrikizumab, their investigational treatment for moderate-to-severe atopic dermatitis and potential rival to Sanofi/Regeneron Pharmaceuticals’ blockbuster drug Dupixent (dupilimumab).

Lebrikizumab is among eight new products for which initial EU marketing authorization applications (MAAs) are listed as being up for...

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• By Francesca Bruce

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Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

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

 
• By Urtė Fultinavičiūtė

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

 
• By Eliza Slawther

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.

More from Geography

Global Pharma Guidance Tracker - July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

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• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.