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EMA’s Rasi: Approval Decision For Remdesivir May Come ‘Very Soon’

 
• By Neena Brizmohun

Speaking at a high-level European Parliament committee meeting today about COVID-19, the European Medicines Agency’s executive director indicated that Gilead would be submitting a conditional marketing authorization application for remdesivir in the EU.

Drug remdesivir for covid 19 coronavirus treatment
The EMA is conducting a rolling review of remdesivir for treating COVID-19 • Source: Shutterstock

A decision by the European Medicines Agency on whether Gilead Sciences’ remdesivir should be authorized in the EU for treating patients with COVID-19 could “come very soon,” according to the agency’s executive director, Guido Rasi.

It might be that a decision on "conditional marketing authorization can be issued in the coming days, subject to the...

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More from Europe

Research Advances & 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.

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.

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

More from Geography

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

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.