Novartis drug Lucentis approved by Japanese regulatory bodies
Lucentis® (ranibizumab) has been approved by Japanese regulatory bodies for a fourth indication: the treatment of patients with…
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21 Feb 14
Lucentis® (ranibizumab) has been approved by Japanese regulatory bodies for a fourth indication: the treatment of patients with…
10 Oct 13
Marketing authorisation applications are becoming larger and increasingly complicated, and the switch from paper to electronic dossiers in…
05 Jul 13
As collaborative clinical research grows in popularity and the industry’s focus moves towards personalised medicine, a crucial debate…
27 Mar 13
As the preferred format for regulatory submissions to the FDA, the eCTD offers strategic advantages to sponsor organisations.…
27 Mar 13
Mollie Shields-Uehling, president and CEO of SAFE-BioPharma Association, explains how the industry’s interests in collaboration and cloud computing…
07 Mar 13
As the pharmaceutical industry faces growing public demand for greater transparency in the publication of drug trial results,…