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Drug & Device News
FDA Withdraws Approval of Avastin for Breast Cancer Treatment
The Food and Drug Administration (FDA) announced on Nov. 18, 2011 that it was had revoked its approval of the drug Avastin for the treatment of metastatic breast cancer. Avastin had been used in conjunction with the cancer drug paclitaxel for treating women with the type of metastatic breast cancer known as HER2 negative. This use was approved by the FDA using the accelerated approval process, but later tests and patient results showed that it only minimally slowed tumor growth, and that no correlation between the use of Avastin and greater longevity could be shown. In a release announcing the FDA's action, FDA Commissioner Margaret Hamburg said, “As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be and the need for good treatment.” However, although many women with metastatic breast cancer saw Avastin as part of their life-saving regimen of treatment, Hamburg said the FDA needed to withdraw its approval of the drug for their use because it “found after rigorous testing the side effects of Avastin were more damaging than the benefits.” These side effects include high blood pressure and hemorrhaging. Avastin remains FDA-approved for the treatment of certain types of colon, lung, kidney and brain cancers.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.