On October 10, 2024, the FDA approved Accord BioPharma’s Imuldosa™ (ustekinumab-srlf), the fifth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa™ was developed by Dong-A ST in collaboration with Meij…
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/ Business Organizations, Health, Intellectual Property, Science, Computers, & Technology
On Wednesday, October 16, 2024, the Office of the U.S. Trade Representative (USTR) published a Federal Register notice announcing that the agency opened an electronic portal for exclusion requests for "Certain Machinery Used in…
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/ Antitrust & Trade Regulation, Business Organizations, International Law & Trade
As we head into the final weeks of the 2024 election campaigns, it's likely that American workplaces will be filled with employees discussing, arguing over, and participating in one of the country's hundreds of local, statewide,…
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/ Business Organizations, Elections & Politics, Labor & Employment Law
By a 3-2 vote, the Federal Trade Commission (FTC) announced its Final Negative Option Rule that covers negative option programs for both consumer and B2B transactions in any media, including online, telephone, print, and…
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/ Antitrust & Trade Regulation, Business Torts, Consumer Protection
On September 27, 2024, in J. Doe 1 v. Github, Inc., 22-cv-06823-JST, the U.S. District Court for the Northern District of California certified an order dismissing Plaintiffs' claims under Section 1202(b) of the Digital…
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/ Civil Procedure, Intellectual Property, Science, Computers, & Technology
The government recently issued final rules on the Mental Health Parity and Addiction Equity Act (MHPAEA). The rules implement requirements for plans to conduct a comparative analysis of their nonquantitative treatment…
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/ Health, Insurance, Labor & Employment Law
Earlier this year, Merck Sharp & Dohme, LLC (“Merck”) requested inter partes review (“IPR”) of a number of patents owned by the Johns Hopkins University (“JHU”)…
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/ Intellectual Property, Science, Computers, & Technology
Welcome to The On-Ramp, the newsletter published by Venable's Autonomous and Connected Mobility Team. The On-Ramp explores legal and policy developments in the world of autonomous and connected vehicles, smart infrastructure,…
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/ Science, Computers, & Technology, Transportation
On October 10, 2024, the Federal Trade Commission (FTC) unanimously approved a final rule that makes sweeping changes to the substance of premerger notifications required under the Hart-Scott-Rodino (HSR) Act…
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/ Antitrust & Trade Regulation, Business Organizations, Mergers & Acquisitions
In a guest article, Venable's Rebecca Liebowitz, Andrew D. Price, and Samantha J. Moskowitz examine the rise in increasingly sophisticated trademark fraud and what practitioners can do to minimize the risks for clients…
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/ Intellectual Property
To protect its data and better compete in the market, an organization must treat its data as an intellectual property. That means understanding the different intellectual property regimes and their accompanying requirements. In…
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/ Intellectual Property, Science, Computers, & Technology
It’s October and, in addition to playoff baseball, that means the Supreme Court is back in session. The Court has chosen to hear arguments in two cases with significant ramifications for advertising law…
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/ Communications & Media Law
On October 4, 2024, Amgen filed Case No. 1:24-cv-09555 (N.D. Ill.) against Fresenius Kabi, alleging FKS518 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 33 of Amgen’s patents…
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/ Intellectual Property, Science, Computers, & Technology
There are numerous considerations in structuring the board of directors of a nonprofit organization, including optimal size, qualifications, responsibilities, diversity, succession, compensation, and voting rights, to name a…
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/ Nonprofit Law
The Department of Justice's Criminal Division is "using more tools than ever before to identify corporate misconduct and to encourage companies to be good corporate citizens," according to Nicole Argentieri, Principal Deputy…
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/ Business Organizations, Science, Computers, & Technology
