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Astellas

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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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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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AstraZeneca shares promising phase 3 results for Imfinzi in bladder cancer

More than 614,000 people are diagnosed with bladder cancer globally every year

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

Astellas’ Vyloy approved by FDA as first-line gastric cancer combination treatment

Approximately 26,890 new cases of gastric cancer will be diagnosed in the US this year

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Merck and Astellas/Pfizer’s bladder cancer combination receives MHRA approval

About 614,000 people are diagnosed with bladder cancer globally every year

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Astellas and AviadoBio enter exclusive dementia gene therapy deal worth over $2bn

Frontotemporal dementia accounts for less than one in 30 cases of the neurodegenerative disorder

- PMLiVE

ICR researchers reveal benefits of personalised radiotherapy for bladder cancer patients

More than 130,000 patients are treated with radiotherapy on the NHS every year

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