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New agency

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Cross-functional alignment

By Professor Brian D Smith

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GSK’s ViiV submits application for cabotegravir to EMA for HIV-1 prevention

Cabotegravir offers up to two months of protection from a single injection

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Act-Accelerator outlines plans for longterm COVID-19 control

Its plan highlights key priorities as countries transition to manage the public health issue

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FDA receives Santhera and ReveraGen’s application for Duchenne muscular dystrophy treatment

The submission includes positive data from the pivotal phase 2b and four open-label studies

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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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NHS England hits ten million in autumn COVID-19 booster campaign

Health leaders have warned of a COVID-19 and flu ‘twindemic’ this winter

Personalized Oncology: Calling for a New Kind of Partnership:

In the 1990s, biomarkers were the future of personalized medicine and a “lab on a chip” was the holy grail of understanding patient health. As much as past predictions of...

Inizio

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Are smart deals a clever solution to UK market access?

By James Lister, Ewa Kania and Janica Auluck

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Almirall granted EMA approval for lebrikizumab in atopic dermatitis

The Marketing Authorization Application is based on three pivotal phase 3 studies

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GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

A final decision for daprodustat by the FDA is expected by 1 February 2023

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WHO reveals tuberculosis deaths rose due to COVID-19 disruption

An estimated 10.6 million were infected with TB in 2021, an increase of 4.5% from 2020

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New evidence review uncovers ‘significant’ link between particulate matter and dementia

Information from 17 existing studies was reviewed, involving 91 million people

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