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GLP1 agonists

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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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Novo Nordisk and Vivtex partner in deal worth up to $2.1bn

The companies aim to develop next-generation oral medicines for obesity and diabetes

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Novo Nordisk and Aspect Biosystems expand collaboration on diabetes research

The companies are working together on cellular medicines to boost, replace or repair biological functions

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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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Eli Lilly shares promising phase 3 results for once-weekly insulin candidate efsitora alfa

The company is planning to submit regulatory applications for the candidate by the end of the year

regeneron headquarters

Regeneron gains rights to Hansoh’s GLP-1/GIP receptor agonist in deal worth $2bn

The candidate is being evaluated in a phase 3 obesity trial and phase 2b diabetes study

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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

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Eli Lilly announces $3bn expansion to US injectables manufacturing facility

The investment will help Lilly meeting the growing demand for its diabetes and obesity medicines

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