Category: Regions

September 17, 2019 Off

Purdue Pharma files for bankruptcy; settlement to provide more $10B to address opioid crisis

By BusinessWire

STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. today announced that it has reached an agreement in principle on a framework for settling the U.S. opioid litigation facing the Company with 24 state attorneys general, analogous officials from 5 U.S. territories, the Plaintiffs’ Executive Committee in the multidistrict litigation (MDL), and co-lead counsel in the MDL.

September 16, 2019 Off

Janssen files for sBLA to FDA for Tremfya

By Dino Mustafić

The Janssen has filed for a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of guselkumab brand Tremfya, for the treatment of adult patients with active psoriatic arthritis (PsA), and expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.