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EMA Says Yes To GSK’s Belantamab But Rejects Tagraxofusp & Emapalumab

 
• By Neena Brizmohun

GlaxoSmithKline's first-of-its kind treatment for multiple myeloma is among 11 new medicines that have won an EU approval nod from the European Medicines Agency this week.

Concept of national healthcare system - EU - European Union
The EMA has this month recommended EU approval for a number of new drugs • Source: Shutterstock

The European Medicines Agency has this week recommended for EU approval a raft of new drugs, including Blenrep (belantamab mafodotin), GlaxoSmithKline’s first-of-a-kind treatment for multiple myeloma that last week overcame ocular toxicity concerns to win a US Food and Drug Administration panel endorsement.

Blenrep, which is now set to become the first BCMA (B-cell maturation antigen)-targeting therapy for multiple myeloma, should be granted a conditional marketing authorization (CMA), said the EMA, which like the FDA noted that there were corneal risks associated with the product

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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.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
• By Cathy Kelly

Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.

More from Geography

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.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.