Roche lands EU Kadcyla approval, ducks EMA criticism

Share this article:

Roche is riding a wave of good news. The company announced Wednesday that the EU greenlighted Kadcyla for HER2-positive breast cancer. The US approved the drug this year, but the OK was accompanied by questions about its viability. The so-called “super Herceptin” was expected to cost around $94,000 for a standard course of treatment, and the approval overlapped just as a pricing standoff between Memorial Sloan-Kettering and Sanofi ended with the drugmaker yielding on price.

The company is also breathing easy-ish because the European Medicines Agency decided that the firm's failure to reveal 80,000 adverse-events reports was no big deal. FiercePharma reports that Roche says the number of unreported AEs was really 23,000 and the EMA says these incidents were not associated with any negative outcomes.

Share this article:

Email Newsletters

More in Business Briefs

Miss Idaho shows off diabetes pump

NPR reports that the move has made Sierra Sandison a type 1 diabetes hero and that users have given the Facebook photo over 4,000 "likes."

Roche is hungry, not starving for M&A

CEO Severin Schwan tells Reuters that the Swiss firm will be looking for small acquisitions and partnerships.

AbbVie nabs Shire for $54B

AbbVie, in the latest example of a US drugmaker seeking to lower its tax rate, said today that it's buying Dublin-based Shire for $54 billion.