Monthly Archives: July 2010
Merck KGaA MS Drug on the Fast Track
Merck KGaA received word July 25 that its application for the multiple sclerosis treatment Cladribine had received priority review status by FDA, decreasing the evaluation period from 10 months to six months, and closing the gap between Merck and the competition.
“This is a critical milestone on the path to potential approval for short-course therapy with [...]
Study: Future of Personalized Medicine
An increased focus on targeted medicine has become a staple for all facets of healthcare, from drug developers to consumers to pharma companies. Gerson Lehrman and Bloomberg jointly commissioned a survey that gauged the reactions and predictions of this trend from 52 leading US physicians. The survey covered a number of topics to assess which [...]
Posted in R&D Tagged Biotechnology and Pharmaceuticals, business, Health, Health care, Medicine, Personalized medicine, Physician, Research and development 1 Comment
Europe: Resisting the Anticompetitive Crusade
It’s been another rocky few weeks for pharma in Europe. Particularly for big brand name companies. But necessity is proving the mother of invention, says Pharm Exec’s Brussels correspondent, Reflector.
AstraZeneca suffered a serious setback at the start of July when the European General Court ruled that it had illegally prevented generic competition. The case dates [...]
Posted in Strategy Tagged AstraZeneca, Belgium, Commission, Competition law, European Commission, European Union, Generic drug, Pharmaceutical drug Leave a comment
Advisory Panel Rejects Avastin For Breast Cancer Treatment
An FDA advisory panel on Tuesday voted 12–1 to discontinue Avastin (bevacizumab) as a treatment for advanced breast cancer due to post-market studies stating that the treatment does not to increase patient lifespan by any significant length of time.
This is a huge problem for Roche who purchased the treatment as part of its merger with [...]
Posted in FDA, Safety Tagged Avastin, Bevacizumab, Breast cancer, Cancer, Chemotherapy, Clinical trial, Food and Drug Administration, Genentech, Roche 1 Comment

Why Won’t Andrew Witty Take the Dive? (Updated 7/30/10)