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HLX11

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Sandoz announces collaboration agreement with Shanghai Henlius Biotech

The agreement for up to ten biosimilar assets represents one of largest ever biosimilar collaborations for the company

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EMA recommends granting marketing authorisation approval for Nezglyal

The treatment is for cerebral adrenoleukodystrophy, a rare neurodegenerative disease

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AstraZeneca’s Trixeo recommended by CHMP for approval in EU for asthma

Asthma affects over 360 million people worldwide, including over 40 million people in Europe

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Almirall’s paediatric registration of Ebglyss for atopic dermatitis gets EMA acceptance

Atopic dermatitis affects a significant number of children and adolescents and often peaks in childhood

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Regeneron’s New Drug Application for cemdisiran accepted for review by FDA and EMA

Globally, around 150 to 200 out of every million people have myasthenia gravis

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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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J&J’s Darzalex recommended by CHMP to treat smouldering multiple myeloma

If approved, Darzalex would be the first therapy approved in the EU for SMM

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