Pfizer puts the heat on Novartis with FDA MenB filing

June 17, 2014 9:01 PM

18 0

There's nothing like a neck-and-neck race, and that's just what Pfizer's ($PFE) breakthrough-designated meningitis B candidate created when stellar Phase II data helped it surge ahead on its regulatory pathway to catch up with Novartis' ($NVS) Bexsero. And now, with the two companies submitting applications for approval on the same day, whether Pfizer's jab reaches the market first will be up to the FDA to decide.

On Tuesday, the company announced it had handed over a Biologics License Application (BLA) for its meningitis B jab, dubbed rLP2086, to U.S. regulators. The agency now has a review period of 60 days to make sure all looks well and good with the filing, and if it does, it will then announce a final d...

Also read: FDA clears 1st generic film strip of addiction drug Suboxone

Read more

To category page