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- PMLiVE

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

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Fishawack Health deepens key capabilities and builds an integrated delivery model under new Chief Marketing and Creative Officer

Polymath marketer Ryan Mason leads the newly expanded group, and Jeffrey D. Erb has been tapped to grow the media and analytics team as Chief Media Officer.

Avalere Health

- PMLiVE

Janssen’s Akeega receives EC approval for metastatic prostate cancer

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Merck KGaA’s MS drug put on partial clinical hold by FDA

Laboratory results suggested there were two cases of drug-induced liver injury during the phase 3 studies

- PMLiVE

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

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

- PMLiVE

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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