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- PMLiVE

EMA reaffirms guidance on paracetamol use during pregnancy

The guidance follows recent US comments about a possible link to autism

- PMLiVE

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

David Weinreich appointed as Merck’s Global Head of R&D and CMO, Healthcare

Weinreich will be based in Billerica, Massachusetts at the company’s Research and Development site

- 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

- PMLiVE

MSD’s Welireg recommended by NICE to treat rare von Hippel-Lindau disease

Approximately one in every 70,000 people are affected by the tumour-causing genetic disease

- PMLiVE

Merck and Daiichi Sankyo to jointly develop T-cell engager in deal worth over $170m

The partners will evaluate MK-6070 as part of a combination treatment for small cell lung cancer

- PMLiVE

Merck and Astellas/Pfizer’s bladder cancer combination receives positive CHMP opinion

More than 165,000 new cases of bladder cancer are diagnosed in the EU every year

- PMLiVE

Merck’s Keytruda combination recommended by NICE for advanced gastric cancer

More than 6,500 new cases of gastric cancer are diagnosed in the UK every year

- PMLiVE

Merck’s investigational RSV monoclonal antibody clesrovimab shown to protect infants

The respiratory virus accounts for about 30,000 hospitalisations in children under five every year in the UK

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