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13 New Drugs Pass Muster At The EMA, Dexamethasone Withdrawal Explained

 
• By Neena Brizmohun

New products from Paion, Arvelle, Incyte and many others have been recommended for approval by the European Medicines Agency. Meanwhile, the agency has explained why the EU marketing authorization application for Dexamethasone Taw, for treating COVID-19 patients, was withdrawn.

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Numerous new drugs are poised to be approved in the EU • Source: Shutterstock

Byfavo (remimazolam), Paion’s drug for procedural sedation, and Ontozry (cenobamate), Arvelle Therapeutics’ epilepsy treatment, are among the 13 new drugs that the European Medicines Agency has said should be granted pan-EU marketing authorization.

Byfavo is an ultra-short-acting intravenous benzodiazepine that is approved for procedural sedation in the US and China and for general anesthesia in Japan and South Korea. (Also see "On A Roll

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More from Europe

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.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

More from Geography

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

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.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.