1. Pink Sheet

Coronavirus Notebook: WHO OKs Bharat’s Covaxin, AZ Pulls Swiss Vaxzevria Filing

 
• By Ian Schofield

The US FDA has rejected an emergency use authorization application for NRx Pharmaceuticals’ Zyesami (aviptadil) for use in COVID-19 patients with respiratory failure. The UK has revamped its emergency delivery service for drugs that experience shortages as a result of the pandemic and other factors.

A bottle of vaccine and a syringe on a white table on a blue background
Bharat Biotech's coronavirus vaccine can now be more widely used • Source: Alamy

The World Health Organization has granted an emergency use listing (EUL) to Indian company Bharat Biotech’s coronavirus vaccine Covaxin, which the WHO said had shown “78% efficacy against COVID-19 of any severity” 14 or more days after the second dose.

Formulated from an inactivated SARS-CoV-2 virus antigen and available in single- and multi-dose vials, Covaxin is “extremely suitable for low- and middle-income countries

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 International

More from Geography

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.