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- PMLiVE

Scott Gottlieb

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Pfizer and Gero collaborate on fibrotic disease research

The companies will use data to identify genes and pathways linked to fibrotic diseases

- PMLiVE

bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

- PMLiVE

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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FDA approves Ferring’s Adstiladrin as first gene therapy for bladder cancer

Non-muscle-invasive bladder cancer represents around 75% of all new bladder cancer cases

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Roche’s COVID-19 antibody receives FDA approval for hospitalised adults

The decision makes Actemra the first FDA-approved monoclonal antibody to treat COVID-19

- PMLiVE

FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

- PMLiVE

Pfizer shares updated pivotal phase 2 elranatamab data for multiple myeloma

There are 176,000 new cases of the disease worldwide for which there is currently no cure

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FDA approves updated COVID-19 boosters for children aged from six months

The Moderna and Pfizer/BioNTech boosters both target the BA.4/BA.5 omicron subvariants

- PMLiVE

Pfizer’s RSV vaccine candidate accepted for FDA priority review for use in older adults

A phase 3 study showed the vaccine was 85.7% effective in those with three or more symptoms

- PMLiVE

Pfizer and Clear Creek Bio partner on COVID-19 antiviral research programme

The companies will identify a papain-like protease candidate to progress into the clinic

- PMLiVE

Pfizer/BioNTech submit FDA application for BA.4/BA.5 COVID-19 vaccine in children under five

The vaccine is already authorised as a booster for ages five years and older in the US and EU

- PMLiVE

FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

Phase 2 data showed a complete remission rate of 35% and median duration of 25.9 months

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