Replies to post #179395 on Biotech Values

[jq1234]

When was last time two competing products from two different companies submitting BLAs on the same day?

[DewDiligence]

FDA approves PFE’s Trumenba (meningitis-B vaccine) for patients age 10-25:

http://finance.yahoo.com/news/pfizer-receives-fda-accelerated-approval-184400815.html

This is an Accelerated Approval based on immune response (a surrogate marker); an outcome study is in progress.

NVS has a pending BLA for a similar vaccine (#msg-103391258).

[DewDiligence]

FDA approves GSK/NVS’ Bexsero meningitis-B vaccine:

http://finance.yahoo.com/news/novartis-bexsero-vaccine-approved-fda-224202663.html

A similar vaccine from PFE, called Trumenba, was approved by the FDA in Oct 2014 (#msg-107658855). Both products are approved for people aged 10-25. Curiously, the two BLAs were submitted on the same day (#msg-103391258).

NVS developed Bexsero, but it now belongs to GSK as part of the asset transfer between these companies announced in Apr 2014 (#msg-100909502).

Please see #msg-79734337 for background info on meningitis B.