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lower respiratory tract disease

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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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Pfizer’s maternal RSV vaccine candidate shows promise in phase 3 trial

The company stopped the trial early and plans to file for US approval by the end of 2022

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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 respiratory syncytial virus older adult vaccine given Priority Review by FDA

There are currently no RSV vaccines approved for older adults anywhere worldwide

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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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BeiGene’s Brukinsa receives CHMP recommendation for chronic lymphocytic leukaemia

CLL accounts for around one-quarter of new leukaemia cases

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GSK announces positive phase 3 results of RSV vaccine candidate in older adults

RSV infections in older adults account for around 177,000 hospitalisations in the US each year

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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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AstraZeneca/Sanofi’s Beyfortus receives CHMP recommendation for prevention of RSV disease in infants

Beyfortus reduced the incidence of medically attended lower respiratory tract infections caused by RSV

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EMA accepts Otsuka and Astex’s marketing authorisation application for acute myeloid leukaemia treatment 

The application is supported by results from a phase 3 trial demonstrating an exposure equivalence to the current standard of care for AML

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EMA accepts Mundipharma’s application for invasive candidiasis treatment rezafungin

Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%

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