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Pentavalent Meningococcal Vaccine Among Latest EU Filings

 
• By Neena Brizmohun

Marketing applications for MenABCWY, zolbetuximab, crovalimab, macitentan/tadalafil, Coacillium, mRNA-1345, dasiglucagon and ustekinumab have been submitted to the European Medicines Agency for review.

EU marketing applications for new medicines have started the review process • Source: Shutterstock

The European Medicines Agency has begun reviewing EU marketing authorization applications (MAAs) for a new batch of medicines, including one for MenABCWY, Pfizer’s investigational pentavalent meningococcal vaccine, which, if approved, could provide the broadest serogroup coverage of any meningococcal vaccine.

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More from Product Reviews

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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.