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EMA OKs First Drug To Prevent RSV Infection In Babies

Takeda Pulls EU Filing For Exkivity To Prevent CHMP Rejection

 
• By Vibha Sharma

A new medicine to protect newborns and infants from RSV infection and a new treatment for DLBCL are among a dozen drugs that have been recommended for pan-EU approval.

Toddler boy using nebulizer to cure asthma or pneumonia disease . Sick baby boy rest on patients bed and has inhalation therapy by the mask of inhaler. Respiratory Syncytial Virus (RSV).
RSV can be serious, especially in infants • Source: Shutterstock

AstraZeneca/Sanofi’s Beyfortus (nirsevimab) is on track to become the first preventative option for respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants following the European Medicines Agency’s recommendation that it be granted EU-wide marketing approval.

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More from Europe

More from Geography

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.