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- PMLiVE

Trelegy

- PMLiVE

GSK and CureVac sign deal with Germany for mRNA COVID-19 vaccines

The agreement is part of a Pandemic Preparedness Contract and means millions of vaccines can be produced at short notice during future public health emergencies

- PMLiVE

Sanofi’s asthma treatment approved by European Commission

Dupixent is suitable for 6- to 11-year-old children who have severe asthma and type 2 inflammation

- PMLiVE

EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

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EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

EU flag

EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

dengue fever mosquito

WHO has recommended GSK’s malaria vaccine for children

This is the first and only malaria vaccine to have been shown in pivotal long-term clinical trials to significantly reduce malaria in children

- PMLiVE

Future of MHRA uncertain amid Brexit-fuelled shake up

Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

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Tezepelumab effective in severe asthma with comorbid nasal polyps

Amgen’s novel drug offers hope to the one-in-five people with severe asthma who also have nasal polyps

- PMLiVE

GSK beats expectations thanks to strong vaccine sales in Q2

GSK's vaccine business was up by 39% to £1.6bn thanks to the strong growth (46%) of its meningitis vaccine

- PMLiVE

EMA begins rolling review of Sanofi, GSK’s COVID-19 vaccine

Rolling review launched based on preliminary results from lab studies and early clinical studies

- PMLiVE

GSK reveals plans for £400m R&D facility expansion in England

GSK has formally started the process of seeking a development partner for the expansion plans

- PMLiVE

bluebird bio to restart marketing of Zynteglo in EU after previous suspension

EMA’s safety committee PRAC has confirmed favourable risk-benefit balance of gene therapy

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