1. Scrip
  2. >>COVID-19

Coronavirus Update: Paxlovid Moves Towards EU Approval, Moderna Targets Omicron

Plus, New China Alliance, Daiichi Assesses mRNA Booster

 
• By Scrip Team

Pfizer gets European Commission approval for Paxlovid after a positive CHMP opinion, while Moderna started a Phase II study of its Omicron-specific vaccine candidate. Meanwhile, China's Junshi enters into a new oral antiviral collaboration while Daiichi Sankyo investigates its mRNA vaccine contender as a booster shot.  

Coronavirus mask
• Source: Shutterstock: Lightspring

Pfizer Inc. has snagged a conditional marketing authorization (CMA) from the European Commission (EC) for Paxlovid (nirmatrelvir and ritonavir), for patients with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe disease. The decision came just a day after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug. (Also see "EU Approves Paxlovid For COVID-19" - Pink Sheet, 27 January, 2022.)

The CMA follows by about a month the 22 December US Food and Drug Administration’s emergency use authorization for the two-drug therapy, which preceded by one day its EUA for Merck & Co., Inc

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 COVID-19

Arcturus and CSL Take on Pfizer With Longer-Lasting COVID Vaccine

 
• By Kevin Grogan

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

Under-Pressure Moderna Banks $590m To Speed Up Bird Flu Vaccine

 
• By Kevin Grogan

A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.

Stock Watch: Q3, Bonfire Of The Vaccine Manufacturers

 
• By Andy Smith

Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.

Meiji Considers Legal Action Amid Japan Misinformation On Kostaive Vaccine

 
• By Lisa Takagi

Japanese distributor Meiji Seika Pharma is considering possible legal action against what it views as online slander around COVID-19 vaccine Kostaive, which received its global-first approval in Japan last year and has now been launched for regular vaccination in the country.

More from Scrip

Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

 
• By Mandy Jackson

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pharma Left Hanging After US/UK Trade Pact

 
• By Kevin Grogan

An ‘historic economic prosperity deal’ does not include the sector.