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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

- PMLiVE

EMA reaffirms guidance on paracetamol use during pregnancy

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

tijana being interviewed

Envision Analogue – An Introduction

Powered by primary payer market research, Envision is an online platform that provides forward-looking evaluations and comprehensive strategic direction for market access viability after an oncology product has received positive...

Genesis Research Group

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AstraZeneca’s Tagrisso combination receives CHMP recommendation for advanced lung cancer

More than 450,000 people are diagnosed with lung cancer every year in Europe

- PMLiVE

Pfizer’s one-time haemophilia B therapy Durveqtix receives CHMP recommendation

More than 38,000 people worldwide are currently affected by the inherited bleeding disorder

- PMLiVE

FDA approves Servier’s Tibsovo as first targeted therapy for rare blood cancer

Approximately 16,000 people in the US are diagnosed with myelodysplastic syndromes every year

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