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EMA Says Yes To 12 New Drugs Including Pfizer/AbbVie’s Antibiotic Combo

 
• By Neena Brizmohun

Emblaveo, for fighting infections caused by multidrug-resistant bacteria, is among the latest batch of medicines that the European Medicines Agency says should be approved for use in the EU.

New medicines are set to be approved for use in the EU soon • Source: Shutterstock

The European Medicines Agency has recommended in favor of pan-EU marketing authorization for a new batch of drugs, including Pfizer/AbbVie’s antibiotic for infections caused by multidrug-resistant bacteria, Emblaveo (aztreonam-avibactam).

Awiqli (insulin icodec), Novo Nordisk’s once-weekly treatment for diabetes, and Fabhalta (iptacopan), Novartis’s oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), also received the thumbs up from the EMA, as did

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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

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
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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.

More from Geography

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

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• By Francesca Bruce

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