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EMA Thumbs Up For HyQvia As Maintenance Therapy For Rare Neurological Disorder

 
• By Vibha Sharma

The European Medicines Agency has recommended in favor of allowing new uses of four already-approved drugs and suspending the marketing authorization of several generics tested by an Indian-based CRO. 

Businessman showing thumbs up - closeup shot
Four EU Medicines Are On Track For Labeling Changes Following Positive CHMP Opinions • Source: Shutterstock

Takeda/Baxalta Innovations’ immune globulin (IG) treatment HyQvia (human normal immunoglobulin) is on track to secure a new EU-wide indication as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

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More from Europe

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

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

 
• By Andrew McConaghie

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

 
• By Eliza Slawther

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 Dave Wallace

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.

More from Geography

New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 
• By Neena Brizmohun

Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.

Global Pharma Guidance Tracker March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth