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Drug & Device News
To Address Shortages, FDA Allows Import of Unapproved Cancer Drugs
Responding to concerns that supplies of certain cancer treatment drugs had become dangerously short, the U.S. Food and Drug Administration (FDA) took steps in February to address the crisis; the agency temporarily authorized the import of two unapproved medications. The FDA announced it would allow the importation of the drug Lipodox (doxorubicin hydrochloride liposome injection), manufactured by India's Sun Pharma Global, to replace Doxil (doxorubicin hydrochloride liposome injection). Doxil, which is commonly used to treat certain ovarian cancer patients and patients with AIDS-related Kaposi's sarcoma or multiple myeloma, became scarce after the drug's manufacturer shut down production at its Ohio facility late last year. The FDA, which in rare emergency circumstances allows the importation of unapproved drugs that are critical to patients, expects the Lipodox imports to meet all U.S. patient needs.
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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.
Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs
A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.
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?
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.
Coverage Issues Stemming from Dry Cleaner Contamination Suits
In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.