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regulatory decisions

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AstraZeneca receives CHMP recommendations for Imfinzi, Enhertu and Lynparza

The treatments are for use in prostate, biliary tract and advanced gastric cancer

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Sanofi/Regeneron’s Dupixent receives CHMP recommendation for prurigo nodularis

Two phase 3 trials showed a reduction in itch, skin lesions and health-related quality of life

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Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation for children five to 11 years

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

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BeiGene’s Brukinsa receives EC approval for marginal zone lymphoma

The BTK inhibitor was also granted an additional year of marketing protection

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EMA issues new guidance to limit use of JAK inhibitors for chronic inflammatory disorders

The guidance aim to minimise the risk of serious side effects associated with these medicines

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GSK’s application for its RSV vaccine accepted by EMA under accelerated assessment

The vaccine demonstrated overall efficacy of 82.5% in adults aged 60 years and older

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AbbVie submits application for lymphoma therapy epcoritamab to EMA

Phase 2 trial showed an overall response rate of 63% and a complete response rate of 39%

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Takeda’s dengue vaccine candidate recommended for approval by CHMP

Dengue disease causes around 390 million infections and 500,000 hospitalisations each year

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Novartis bags CHMP recommendation for prostate cancer drug Pluvicto

The recommendation is for use in combination with androgen deprivation therapy

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BeiGene’s Brukinsa receives CHMP recommendation for chronic lymphocytic leukaemia

CLL accounts for around one-quarter of new leukaemia cases

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EMA accepts Santen’s application for glaucoma treatment STN1013001

The intraocular pressure lowering efficacy was demonstrated in a phase 3 trial

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Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

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