Monthly Archives: July 2008

Merck's Yarno Waves Goodbye

By Joanna Breitstein | Published: July 14, 2008
After more than 25 years at Merck, Wendy Yarno, the company’s chief marketing officer, will retire. The announcement of Yarno’s stepping down was made this morning in an e-mail to Merck employees. Yarno joined Merck in 1983 as a sales rep, went on to launch Cozaar and Hyzaar, and then eventually was named to oversee marketing [...]
Posted in People | Tagged , , , , , | 1 Comment

FDA to Pharma: ‘No More Drug Rejections!’

By Walter Armstrong | Published: July 11, 2008
Say goodbye and good riddance to FDA approvable letters! And nonapprovables too! Welcome to the new feel-good Center for Drug Evaluation and Research (CDER), where no drug will ever be rejected again. So is it finally a free-for-all for Big Pharma? Not quite. If anything, given the agency’s stepped-up policing of safety signals, the drug approval rate [...]
Posted in R&D, Regulatory, Safety | 2 Comments

Gene Therapy Files for Approval

By Patrick Clinton | Published: July 1, 2008
An estimated one thousand clinical trials have been conducted for gene therapies in the past 20 years, but to date, not a single drug has made it to FDA approval. However, we may be a step closer as Introgen today announced that it has filed applications with FDA and EMEA for marketing approval of Advexin, [...]
Posted in Gene therapy, R&D | Leave a comment