Coronavirus Notebook: Russia Has “No Immediate Plans” To File Sputnik V In UK Or US; EU Pressured On Vaccine Contract Disclosure

The European Commission insists companies will deliver vaccines on schedule, the Ombudsman starts up a new inquiry into access to vaccine deal documents, and Europe’s disease control center kicks off its “COVID-19 vaccine tracker.”

Corona virus vaccine sample, Concept image for Russian world's first approved vaccine called Sputnik V
An analysis of the Sputnik V vaccine Phase III trial results has been published • Source: Shutterstock

Pressure is growing on the European Commission to disclose details of meetings that have been held with pharmaceutical companies to discuss advance purchase agreements for COVID-19 vaccines.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

EMA’s Role In Regulatory Reliance For Post-Approval Changes

 
• By 

The European Medicines Agency’s assessments of applications for variations play a key role in supporting international regulatory reliance mechanisms. Companies can aid this by ensuring the scope of their post-approval changes is clear, and notifying the EMA when sharing reports with non-EU regulators.

Semaglutide For MASH Among Raft Of New EU Filings

 

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

 

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

More from Geography

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.