Important: New Login Process

We've updated our access and security system. The first time you log in, enter your work email, and we'll guide you through the process.

  • If your organization uses Single Sign-On (SSO), you will be redirected to your company's login portal.
  • If you log in with a username and password, you will be prompted to set a new password before accessing your account.

Go to the Login Page to get started.

We appreciate your cooperation during this transition. If you need assistance, please call +1 650-552-4224 or email support@biocentury.com.

BioCentury
DATA GRAPHICS | Data Byte

EMA agency suggests pulling Translarna, BlenRep from market

CHMP’s September opinions also include approval of seven new medicines and label extensions for 11

September 16, 2023 12:46 AM UTC

The recommendations by EMA’s CHMP to approve seven new therapies, including a biosimilar, and label extensions for 11 others were overshadowed by the committee’s decision to recommend against renewing the conditional approval of PTC Therapeutic’s DMD therapy Translarna.

Shares of  PTC Therapeutics Inc. (NASDAQ:PTCT) fell $11.13 (30%) to $26.26 Friday, knocking $838.6 million off the company’s market cap, after CHMP concluded the condition approval of Translarna ataluren should neither be converted to full approval nor renewed as conditional, following “full re-evaluation of the benefits and risks of the medicine,” including new data from study 041 that “failed to confirm Translarna's effectiveness.” ...

Get Unlimited Access
Continue reading with a free trial.
Or Purchase This Article