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MHRA

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BeiGene’s Brukinsa granted two new marketing authorisations by MHRA

The BTK inhibitor is now approved for chronic lymphocytic leukaemia and marginal zone lymphoma

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MHRA set to receive nearly £1m from BEIS’ Regulator’s Pioneer Fund

Funding will aid three projects aiming to harness digital, data and scientific regulatory innovation

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UCB’s Epicensus programme highlights need to address psoriasis care gap

The programme was published in Dermatology and Therapy

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MHRA approves LEO Pharma’s Adtralza for adolescent patients with atopic dermatitis

The changes to the terms were also approved by the EC in October

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Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer

The treatment will be made available immediately through an early access deal with NHS England

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Novavax’s COVID-19 vaccine receives MHRA approval for use as a booster

Nuvaxovid was shown to increase antibody levels when used as a third booster

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Pfizer/BioNTech’s second bivalent COVID-19 booster approved by MHRA

The adapted vaccine targets the original virus and Omicron BA.4 and BA.5 strains

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MSD’s Vaxneuvance approved by MHRA for prevention of pneumococcal diseases in children

The decision marks the first new vaccine approved by MHRA in a decade for this indication

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Novartis’ Cosentyx receives MHRA approval for two types of juvenile idiopathic arthritis

A phase 3 trial showed significantly longer time to flare for both JPsA and ERA patients

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AstraZeneca’s Tezspire receives MHRA approval as add-on treatment for severe asthma

Tezspire demonstrated reduced annualised rate of asthma exacerbations

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Pfizer/BioNTech BA.1 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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Moderna’s Omicron BA.1 targeting bivalent booster recommended by CHMP for use in EU

Results from a phase 2/3 trial demonstrated mRNA-1273.214 had superior neutralising antibody response against Omicron compared to the currently authorised booster

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