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Drug & Device News
Manufacturer Goes to Court to Challenge FDA's Restrictions on Off-Label Drug Use Promotion
In a May 7 filing with the U.S. Securities and Exchange Commission (SEC), the pharmaceuticals manufacturer Amarin Pharma, Inc., a wholly-owned subsidiary of Amarin Corporation Plc, announced that it had filed suit in the U.S. District Court for the Southern District of New York seeking a declaration permitting it to share truthful and non-misleading information about its drugs with U.S. health care professionals, even if the Food and Drug Administration (FDA) considers those declarations non-permissible promotion of off-label drug use. The lawsuit claims that regulation of truthful and non-misleading information is unconstitutional under the First Amendment ' because it curtails freedom of speech ' and under the Fifth Amendment ' because the FDA's regulation is vague as applied to the company's proposed promotion of its drug, Vascepa, a prescription omega-3 fatty acid.
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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.
Supreme Court Rules Rejection of Trademark License Does Not Rescind Rights of Licensee
Mission Product Holdings, Inc. v. Tempnology, LLC The question is whether a debtor's rejection of its agreement granting a license "terminates rights of the licensee that would survive the licensor's breach under applicable nonbankruptcy law."