Posts Tagged: "european medicines agency"

Pharma Law and Business Roundup for March 2013

In response to the scandal over a fungal meningitis outbreak, the FDA has begun a crackdown on compounding pharmacies and targeting about 30 ‘high risk’ operations in nearly a dozen states. San Francisco officials approved a referendum that will allow residents to decide whether to require city officials to hold talks with drug makers about pricing for ‘essential medicines.’ A federal appeals court upheld the conviction of a former biotech chief executive, who argued that federal prosecutors violated his First Amendment and commercial speech rights. The Federal Trade Commission filed a brief siding with generic drug makers in dispute with brand-name drug makers. At issue is whether a brand-name drug maker should be required to sell samples of its medicine to an aspiring generic rival when its medicine was approved with a Risk Evaluation and Mitigation Strategy.

FDA: No to Breast Cancer Drug, Could Cost Genetech $1 Billion

Contrary to the FDA, the European Medicines Agency confirmed that the benefits of Avastin® in combination with paclitaxel outweigh the risks, further determining that the combination of Avastin® and paclitaxel remains a valuable treatment option for patients suffering from metastatic breast cancer. If the FDA is successful in removing the breast cancer indication from Avastin® Genentech (a member of the Roche Group and the maker of Avastin®) could lose $1 billion of its $6 billion in annual sales of Avastin® due to the lost sales associated with use to treat breast cancer.