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COVID-19 Treatment Xevudy Wins UK Approval; Preclinical Data Shows Promise Against Omicron

UK And EU Action As EMA Starts Rolling Review Of Valneva Vaccine

 
• By Neena Brizmohun

New developments on the COVID-19 front also include the European Medicines Agency starting a rolling review of Valneva’s investigational COVID-19 vaccine, and the UK government signing contracts with Pfizer/BioNTech and Moderna to buy more doses of their vaccines.

Covid-19 Image
There have been new developments on the COVID-19 front • Source: Alamy

The UK medicines regulator, the MHRA, has authorized Xevudy (sotrovimab) for treating COVID-19, making the drug from GlaxoSmithKline and Vir Biotechnology the second monoclonal antibody therapeutic to be approved in the UK after Regeneron Pharmaceuticals/Roche’s Ronapreve (casirivimab/imdevimab).

In the EU, meanwhile, the European Medicines Agency has started a rolling review of Valneva’s investigational COVID-19 vaccine, VLA2001, which has been shown in studies to trigger the

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More from United Kingdom

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

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More from Europe

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.