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Triple Combination Therapy First For Asthma Among Eight Wins At EMA

 
• By Neena Brizmohun

Novartis is among a number of companies that this week moved closer to marketing new products across the EU. D&A Pharma has again failed to convince the European Medicines Agency that its alcohol dependence treatment should be approved.

Side view of a dartboard with three darts in the bull's eye. Well-aimed dart throwing. Triple bull's-eye hit. Three well-made dart throws. Successful attempts. To attempt difficult task. Darts ace
Enerzair breezhaler targets asthma with a combination of three active substances • Source: Shutterstock

The European Medicines Agency has recommended marketing authorizations for eight new drugs, including one that is set to become the first EU-approved triple combination therapy for asthma – Novartis’s Enerzair breezhaler ((indacaterol acetate/glycopyrronium bromide/mometasone furoate) (IND/GLY/MF)).

Other products that the EMA this week said should be approved include two orphan drugs – Bristol-Myers Squibb and Acceleron Pharma's Reblozyl (luspatercept), for treating adults with anemia in beta thalassemia and myelodysplastic syndromes (MSD),

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More from Europe

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.

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

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

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.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.