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Atara licenses T cell therapy to Pierre Fabre for up to $640 million

By Jonathan Smith

As it extends its cash runway, the cell therapy developer Atara Biotherapeutics has expanded a partnership with Pierre Fabre Laboratories to commercialize the off-the-shelf T-cell therapy tabelecleucel (tab-cel) for a rare form of blood cancer.

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Genprex bags FDA orphan drug designation for lung cancer therapy

By Isabel Cameron

Genprex has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead candidate, Reqorsa immunogene therapy (quaratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC).

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bluebird bio submits BLA for sickle cell disease gene therapy

By Rachel Arthur

bluebird bio has announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD).

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FDA decision on Pfizer’s maternal RSV vaccine expected by August

By Rachel Arthur

The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV...

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Pfizer and BioNTech submit Omicron booster EUA application to US FDA

By Rachel Arthur

Pfizer and BioNTech have completed their application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine: saying they stand ready to start shipping...