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- PMLiVE

morning brief

- PMLiVE

Novo Nordisk’s type 2 diabetes drug approved by FDA as first-line option

Rybelsus was initially approved in 2019 as a second-line treatment

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California sues largest US insulin manufacturers and PBMs for overpricing

Eli Lilly, Novo Nordisk and Sanofi produce over 90% of the global insulin supply

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GSK and CureVac to advance mRNA COVID-19 and flu vaccine candidates

The vaccines produced promising preliminary results in phase 1 trials

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Pfizer announces positive phase 3 results for haemophilia B gene therapy

A one-off, intravenous dose of the therapy candidate reduced bleeding by 71%

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GSK’s Jemperli shows promise in phase 3 endometrial cancer trial

An interim analysis noted the trial met its primary endpoint of progression-free survival

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GSK’s new global survey exposes lupus treatment gaps

The findings show opportunities to address organ damage risk for early stage lupus patients

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

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

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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

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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

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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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