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Shanghai Henlius Biotech

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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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Roche’s Perjeta-based breast cancer regimen shows sustained survival benefits

Approximately 56,800 new breast cancer cases are diagnosed in the UK every year

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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

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Organon shares positive long-term results for Vtama cream in atopic dermatitis

The common inflammatory skin disease affects more than 26 million people in the US alone

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Rare diseases: Novartis’ Fabhalta recommended by CHMP for C3 glomerulopathy

Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year

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Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa

There is currently only one treatment authorised for the ultra-rare genetic blistering disease

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CHMP recommends Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years

Approximately 480,000 cases of the mosquito-borne viral disease were reported globally in 2024

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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

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Gilead’s seladelpar recommended by CHMP to treat primary biliary cholangitis

The rare liver disease affects approximately 15 per 100,000 people in Europe

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