trending Market Intelligence /marketintelligence/en/news-insights/trending/S8-XKmB3Dnx67q_XfFVNuw2 content esgSubNav
In This List

European regulator asks Portola for additional information about blood thinner

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


European regulator asks Portola for additional information about blood thinner

Portola Pharmaceuticals Inc. said the European Medicines Agency's Committee for Medicinal Products for Human Use requested additional information for its drug betrixaban, which is under review for approval.

Portola's head of research and development, John Curnutte, said the agency's questions can be addressed with existing clinical data. The company has until Jan. 23, 2018, to respond to the questions.

Based on this new timeline, the company expects the EMA's committee to issue an opinion on the drug sometime later in the first quarter of 2018.

Betrixaban is already approved by the U.S. Food and Drug Administration under the brand name Bevyxxa as a blood thinner to prevent and treat clots in patients.