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SK Bioscience Pulls EU Filing For COVID Jab As Regulators Shift Focus To XBB Vaccines

 
• By Eliza Slawther

The European Medicines Agency’s CHMP was set to adopt opinions on SK Bioscience’s COVID-19 vaccine and Mycovia/Gedeon’s Vivjoa for vulvovaginal candidiasis during its September meeting, but both marketing authorization filings were voluntarily withdrawn.

Withdrawn Stamp
• Source: Shutterstock

South Korea’s SK Bioscience voluntarily withdrew its EU conditional marketing authorization application (MAA) for SKYCovion/GBP510, a recombinant COVID-19 vaccine, on 1 September, ahead of this week’s meeting of the European Medicines Agency’s human medicines committee, the CHMP.

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Semaglutide For MASH Among Raft Of New EU Filings

 
• By Neena Brizmohun

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
• By Francesca Bruce

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

More from Geography

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By Leslie Small

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By Sue Sutter

PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.

Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.