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breakthrough status

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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 to expand long-standing Purdue University partnership with $250m investment

The alliance will aim to bring medicines to patients faster using advanced technologies

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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 announces $2.5bn investment in China to boost R&D capabilities

The funds will go towards a new global research and development centre in Beijing’s BioPark

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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Chiesi Group invests €400m to establish biotech centre of excellence in Italy

The facility is dedicated to developing and producing monoclonal antibodies, enzymes and other proteins

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Eli Lilly announces new $4.5bn US site for manufacturing and drug development

The Lilly Medicine Foundry is expected to add 400 full-time jobs for highly skilled workers

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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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Answering some of Pharma’s big questions to drive brand strategies

By James Aird and Zoë van Helmond

Amiculum

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FDA establishes rare disease innovation hub to accelerate treatment development

More than 30 million people in the US are currently affected by a rare disease

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