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  • Diversity, Equity and Inclusion
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PRIME Designation

- PMLiVE

EMA celebrates diversity and inclusion in science and healthcare

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

- PMLiVE

Sanofi’s Tzield gets expanded FDA approval for early-stage type 1 diabetes

The treatment can be used to delay the onset of clinical type 1 diabetes

- PMLiVE

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

- PMLiVE

EMA’s PRIME scheme launches three major new features

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

- PMLiVE

Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input

While a lack of meal announcements can lead to lower glycaemic control, it reduces the mental burden for those with type 1 diabetes

- PMLiVE

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

- 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

- PMLiVE

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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