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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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ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs

On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation...

Genesis Research Group

- 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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Insights From ISPOR 2025: R In Health Technology Assessment – Is It The Future?

ISPOR’s annual meeting in Montreal this May was packed with opportunities to explore the latest trends, insights, and research in HEOR and market access. In this series, our experts share...

Petauri Evidence

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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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Your essential guide to the World EPA Congress 2025: Top sessions and pre-reading

The World EPA organisers have curated an exceptional programme featuring thought-provoking presentations and dynamic panel sessions led by industry leaders driving market access strategy and practice. Following the opening keynote...

Petauri Evidence

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

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What does HEOR really mean in 2025?

Global healthcare systems are under unprecedented strain. As life expectancies rise and populations age, the proportion of people aged 60+ years is expected to soar. This both signals remarkable progress...

Petauri Evidence

Ispor Europe poster winning authors

Genesis Research Group’s ISPOR Europe award-winning poster authors interviewed online

Genesis Research Group's poster 'Payer Perspective on the Impact of Real-world Evidence in Health Technology Assessments of Precision Oncology Treatments Across Europe: Results From an Online Survey' was recently named as...

Genesis Research Group

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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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Best practice RWE approaches to support economic modelling for HTA

How can real-world evidence (RWE) support health technology assessment (HTA)? Join the live webinar on Thursday 3rd October at 1.00pm (BST), featuring panellists from Mtech Access, Arcturis, and Delta Hat.

Petauri Evidence

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