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Accessing Experimental Drugs Through the Compassionate Use Doctrine
In last month's issue, we discussed how Jacob Gunvalson, when denied entry into a clinical trial for a drug that might offer valuable treatment for his terminal disease, Duchenne Muscular Dystrophy (DMD), sued the drug manufacturer to compel it to seek a “compassionate use” exemption from the FDA so that he could take the unapproved drug, PTC 124. In conjunction with that suit, he sought a preliminary injunction, which the district court granted. The drug's manufacturer, PTC Therapeutics Inc., appealed to the U.S. Court of Appeals for the Third Circuit, in Gunvalson v. PTC Therapeutics Inc., Slip Copy, 2008 WL 5227189 (C.A.3 (N.J.), 12/16/08).
The Third Circuit Reverses
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Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
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.
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.
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.
Blockchain Domains: New Developments for Brand Owners
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.