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European Commission

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Novavax’s COVID-19 vaccine granted full marketing authorisation in EU

The EC’s decision was supported by positive results from a phase 3 trial evaluating Nuvaxovid

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European Commission approves Amicus Therapeutics’ Pompe disease therapy

The company can now offer Opfolda together with its previously-approved Pombiliti

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Sanofi and Sobi’s haemophilia A treatment shows effective bleed protection in children

Current factor VIII therapies usually require patients to receive treatment multiple times a week

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European Commission grants two new marketing authorisations for UCB’s Bimzelx

The drug is now approved to treat psoriatic arthritis and axial spondyloarthritis

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GSK’s RSV vaccine approved by European Commission for older adults

RSV infections in older adults account for over 170,000 hospitalisations each year in Europe

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Novartis receives EC approval for Cosentyx in hidradenitis suppurativa

There are around 200,000 people in Europe living with moderate to severe stages of HS

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Sobi to acquire CTI BioPharma for approximately $1.7bn

The deal marks a notable expansion to the Swedish drugmaker's rare haematology pipeline

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Janssen’s Akeega receives EC approval for metastatic prostate cancer

The authorisation marks the first worldwide approval of the niraparib-based combination

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Incyte’s Opzelura cream receives EC approval for non-segmental vitiligo

The decision makes Opzelura the first approved treatment in the EU to address repigmentation in this patient population

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AbbVie’s Rinvoq approved by EC for Crohn’s disease

The therapy is now the first oral JAK inhibitor authorised to treat this patient population

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Bristol Myers Squibb’s Sotyktu approved by EC for plaque psoriasis

At least 100 million people worldwide are impacted by some form of psoriasis

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Sanofi/Regeneron’s Dupixent approved by EC for atopic dermatitis in children

Dupixent is now the first and only targeted medicine in the EU for this patient population

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