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- PMLiVE

morning brief

- PMLiVE

Sanofi/GSK’s next-generation COVID-19 booster granted EC approval

Two trials compared the immune response induced by VidPrevtyn Beta with approved vaccines

- PMLiVE

GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

- PMLiVE

Sarepta to assess imlifidase as pre-treatment to Duchenne muscular dystrophy gene therapy

The company submitted a Biologics License Application to the FDA for SRP-9001 in September

Cell and gene therapies as depicted via a DNA strand

The fast-paced future of cell and gene therapies

In this report, we interview patients, researchers, and biopharmaceutical leaders to explore the complex landscape for the development of cell and gene therapies and share commercial recommendations from our specialist...

Avalere Health

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

GSK’s shingles vaccine demonstrates at least ten-year efficacy in long-term study

ZOSTER-049 follows participants from two phase 3 trials for an additional six years

- PMLiVE

Novo Nordisk completes acquisition of Forma Therapeutics in deal worth $1.1bn

The acquisition includes a pipeline of haemoglobinopathies including etavopivat

Biomarin

BioMarin’s application for haemophilia A gene therapy accepted by FDA

If approved, the treatment would be the first gene therapy in the US for this indication

- PMLiVE

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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