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Huntingdon’s disease

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EMA celebrates diversity and inclusion in science and healthcare

The EU body underlines its commitment to diverse perspectives in medicines regulation

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Astellas’ application to EMA validated for treatment of muscle-invasive bladder cancer

Bladder cancer affects over 224,000 people annually in Europe, with over 30% of cases being muscle-invasive bladder cancer

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EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

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EMA reaffirms guidance on paracetamol use during pregnancy

The guidance follows recent US comments about a possible link to autism

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Johnson & Johnson seeks first EMA approval for icotrokinra for plaque psoriasis

Icotrokinra is a first-in-class, once-daily tablet for moderate-to-severe plaque psoriasis

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EMA orphan drug designation given to ReAlta for graft-versus-host disease therapy

This follows preliminary results from the company's ongoing phase 2 trial

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Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

The reference medicine holds approvals for multiple HER2-positive breast cancer indications

Biogen Idec building

Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA

The neuromuscular disease affects approximately one in every 10,000 babies worldwide

Challenges for orphan medicines entering the European market

We explore the various challenges facing orphan medicines entering the European market and offer solutions to help improve patient access.

Petauri Evidence

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Pfizer/BioNTech’s KP.2-adapted COVID-19 vaccine receives CHMP recommendation

The updated vaccine was shown to generate an improved response against currently circulating variants

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What are “orphan drugs” and how do we navigate the challenges of writing about them?

The first in our 'Ask Alex' series, where Principal Medical Writer, Dr Alexandra Loveday answers some frequently asked questions about Medcomms. This week, she takes a look at 'orphan drugs',...

Mednet

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uniQure’s investigational gene therapy shown to slow Huntington’s disease progression

The neurodegenerative disorder affects approximately 70,000 people in Europe and the US

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