1. Pink Sheet
  2. >>Geography
  3. >>Europe

EU Approval In View For Novavax COVID-19 Vaccine; EMA OKs Janssen Booster

Agency Also Clears Xevudy & Kineret, Advises On Use Of Pfizer's Paxlovid

 
• By Ian Schofield

It’s all go on the EU coronavirus front this week: three new therapies and another vaccine booster have been recommended for use, and a special session on the Novavax vaccine is to be held at the EMA next week. More production capacity has been OKd for three vaccines.

EU flag with vaccine. Mass vaccination against the epidemic of coronavirus
COVID-19: A Priority For Regulators • Source: Alamy

The European Medicines Agency’s human drugs committee, the CHMP, will discuss Novavax, Inc.’s Nuvaxovid at an extraordinary meeting on 20 December where it could well advise that the coronavirus vaccine should be approved. The agency has also recommended the use of a booster dose of Janssen’s approved vaccine.

In addition, the CHMP has given the green light to two potential therapies for COVID-19, Xevudy and Kineret, and has issued advice to the EU member states on using

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
Start Free Trial

Already a subscriber?

More from Europe

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
• By Francesca Bruce

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from Geography

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.