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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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The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Beach Boys Songs Written Decades Ago Triggered Current Quarrel With Lawyers
There's current litigation in the ongoing Beach Boys litigation saga. A lawsuit filed in 2019 against Nevada residents Mike Love and his wife Jacquelyne in the U.S. District Court for the District of Nevada that alleges inaccurate payment by the Loves under the retainer agreement and seeks $84.5 million in damages.
Major Differences In UK, U.S. Copyright Laws
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Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Transfer Tax Implications on Real Property Leases
The real property transfer tax does not apply to all leases, and understanding the tax rules of the applicable jurisdiction can allow parties to plan ahead to avoid unnecessary tax liability.