Orphan Drugs Nefecon, Maribavir & Copanlisib Among New EU Filings

US Filings For The Orphan Drugs Are Under Review

Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.

European Medicines Agency HQ in Amsterdam
The EMA has begun reviewing a new batch of marketing applications • Source: Alamy

The European Medicines Agency has begun reviewing a number of new medicines for potential pan-EU marketing authorization, including three investigational orphan drugs –Nefecon (budesonide), maribavir and copanlisib, from Calliditas Therapeutics, Takeda Pharmaceutical and Bayer respectively.

More from Europe

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By 

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 

While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.

More from Geography

US Pharma Tariff Reprieve May Be Ending

 

Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.