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Coronavirus Notebook: EMA Begins Assessing AZ’s Evusheld, Apeiron Starts Phase I Trial Of Inhaled APN01

 
• By Ian Schofield

The UK has explained its strategy for administering COVID-19 vaccines to people who have been partially immunized abroad.

Inhaler
Apeiron Biologics is trialing an inhaled product for COVID-19 • Source: Shutterstock

The European Medicines Agency has begun a rolling review of another monoclonal antibody (MAb) combination product for the prevention of COVID-19, this time AstraZeneca PLC’s Evusheld, which contains tixagevimab and cilgavimab.

The agency’s human drugs committee, the CHMP, started the rolling review based on preliminary results from clinical studies that suggest the product could help to protect against the disease in...

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More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.