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EU

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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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WHO countries begin negotiations on global pandemic preparedness agreement

The discussions will continue over the next year until a final draft is made in 2024

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European Commission grants AstraZeneca three new approvals

The indications are for adults with liver and lung cancers, and chronic lymphocytic leukaemia

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EC approves first gene therapy for adults with haemophilia B

Typically, haemophilia B patients must adhere to strict, lifelong IV infusion schedules

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EC approves UCB’s Fintepla to treat severe form of epilepsy

Lennox-Gastaut syndrome affects around two in 10,000 people in the EU and usually begins in early childhood

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AstraZeneca’s heart failure treatment approved for expanded use in EU

Chronic heart failure is the leading cause of hospitalisation for those over the age of 65

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Sanofi/Regeneron’s Dupixent approved by EC for eosinophilic oesophagitis

This makes Dupixent the first and only targeted medicine indicated for this condition

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Sandoz’s high concentration Hyrimoz formulation recommended for use in EU

The recommendation includes multiple indications such as rheumatoid arthritis and Crohn’s disease

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