Helixgate

Helixgate

Uncategorized

Atara, Pierre Fabre’s cell therapy to get another shot at FDA approval

Published

on

There’s new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals.

US regulators are willing to reconsider using a Phase 3 study as the basis for an approval, Atara said …

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Uncategorized

EnGene’s shares crash on updated pivotal bladder cancer data

Published

on

EnGene’s latest Phase 2 results on an experimental treatment for certain bladder cancer patients alarmed investors and raised concerns around the therapy’s future prospects.

The Canadian biotech’s shares {$ENGN} fell 80% Thursday morning after reporting …

Continue Reading

Uncategorized

Angelini to buy Catalyst in $4B play for rare neuro drugs

The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.

Read More

Published

on

The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.

Read More

Continue Reading

Uncategorized

FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit

Published

on

The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.

Continue Reading
Advertisement

Trending