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Robins Kaplan LLP

Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

Akin Gump Strauss Hauer & Feld LLP

FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, FluMist, is administered by nasal spray and prevents the flu by using a weakened...more

Goldberg Segalla

What the TFA! Is Trifluoroacetic Acid Another “Forever Chemical” on the Rise?

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A couple of months ago, our blog published an article on the exploding ubiquity of Trifluoroacetic acid (TFA) in the environment. TFA is a breakdown product of several hydrochlorofluorocarbons (HCFC). It is regulated under...more

Akin Gump Strauss Hauer & Feld LLP

FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of Emergency Use

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more

Perkins Coie

Dissenting Commissioners’ Statement in SEC Cyber Disclosure Enforcement Actions May Forecast Change Ahead

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In late October, the SEC announced settled enforcement actions against four public companies, all stemming from impacts from the compromise of SolarWinds’ Orion software. Each order included allegations that the applicable...more

Winstead PC

HIPAA Gets a Potential Counterpart in HISAA

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Americans hear about cybersecurity incidents on a frequent basis. As the adage goes, it is not a matter of “if” a breach or security hack occurs; it is a matter of “when.”...more

Jenner & Block

Client Alert: Beyond the Front Page: Five Things We’re Watching After Election Night

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This week, Donald Trump claimed a decisive victory in the presidential race, and Republicans picked up Democratic Senate seats in West Virginia, Ohio, and Montana, ensuring that they will flip the Senate and hold at least one...more

A&O Shearman

Bank of England Speech on Artificial Intelligence and Financial Stability

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The Bank of England has published a speech by Sarah Breeden, BoE Deputy Governor, Financial Stability, on AI and financial stability. In the speech, Ms. Breeden explores the novel features of Generative AI, and how financial...more

A&O Shearman

Draft Financial Services and Markets Act 2023 (Addition of Relevant Enactments) Regulations 2024 Published

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The draft Financial Services and Markets Act 2023 (Addition of Relevant Enactments) Regulations 2024 have been published, together with an explanatory memorandum. The Regulations add to the list of "relevant enactments" for...more

Sheppard Mullin Richter & Hampton LLP

California Limits Health Plan Use of AI in Utilization Management

California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health...more

Fenwick & West LLP

California’s SB 1120 Regulates AI in Health Plan Utilization Review and Management Activities Starting in January

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On September 28, California Gov. Gavin Newsom signed Senate Bill 1120 Health Care Coverage: Utilization Review into law, amending § 1367.01 of the Health and Safety Code and § 10123.135 of the state’s Insurance Code....more

McGuireWoods LLP

Northern District of Indiana Excludes Battery Expert Opinions Based on Flawed Methods

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On Sept. 30, 2024, the U.S. District Court for the Northern District of Indiana released an opinion and order excluding the opinions of a proposed lithium-ion battery expert. The now dismissed case, American Home Assurance...more

Orrick, Herrington & Sutcliffe LLP

EU Inc: A Vision for a Unified European Corporate Structure

The concept of a pan-European company has garnered renewed attention, with an online petition launched in mid-October amassing over 10,000 signatures in two weeks. The petition advocates for the creation of EU Inc., a new...more

Bergeson & Campbell, P.C.

WEBINAR — Cultivated meat: opportunities and challenges, November 14, 2024, 11:00 a.m. – 12:30 p.m. (EST)

The International Bar Association (IBA) Agriculture and Food Section (AFS) is pleased to present a webinar, “Cultivated meat: opportunities and challenges,” on November 14, 2024, spotlighting the considerable opportunities...more

Allen Matkins

Renewable Energy Update - November 2024 #1

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New high capacity transmission lines are set to open up large parts of western and northern Nevada for solar development. Last month, the Department of the Interior’s Bureau of Land Management (BLM) approved construction of...more

Skadden, Arps, Slate, Meagher & Flom LLP

US Treasury Creates the ‘Reverse CFIUS’ Program, a (Limited) Great Wall on Outbound Investment

The Department of the Treasury (Treasury) has released a final rule imposing restrictions on U.S. outbound investment in Chinese companies active in developing certain national security technologies (Final Outbound Rule)....more

Orrick, Herrington & Sutcliffe LLP

Analysis of the CJEU Judgment Which Paves the Way for Competitor Civil Actions Regarding GDPR Violations

Entscheidung. Man darf sich fragen, warum Kündigungsbeschränkungen gerade im HV-Recht eine vergleichsweise hohe Bedeutung haben, obwohl eigentlich für andere Verträge nichts Abweichendes gelten dürfte. Auch das...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

DOL Issues Updated Guidance on Employers’ Use of AI in the Workplace

Last month, the U.S. Department of Labor (DOL) published updated guidance detailing the principles and practices employers can implement to maximize the use of artificial intelligence (AI) in the workplace while safeguarding...more

Goodwin

Daewoong and Celltrion to Market Denosumab Biosimilar in Korea

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​​​​​​​Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is scheduled to launch in...more

Hogan Lovells

Implementation of the Markets in Crypto-assets Regulation (MiCAR): A Jurisdictional Comparison

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With the Markets in Crypto-Assets Regulation (MiCAR) (Regulation (EU) 2023/1114) becoming fully applicable by the end of this year, crypto-asset service providers seeking to offer their services across the EU need to consider...more

Hogan Lovells

Security Snippets: NIST publishes guide on due diligence for cyber supply chain risk management

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NIST’s “quick-start guide” is designed to assist acquirers as they evaluate the various risks across their network of suppliers, focusing on supply chain tiers, foreign ownership, control or influence (FOCI), provenance,...more

Jones Day

PTAB Denies Institution of Maize-Directed PGR

Jones Day on

On September 24, 2024, the PTAB denied institution of a post-grant review proceeding initiated by Inari Agriculture, Inc. (Petitioner) against Pioneer Hi-Bred International, Inc. (Patent Owner). The patent at issue was U.S....more

Goodwin

FDA Accepts BLA for Shanghai Henlius Biotech’s and Organon’s HLX14, a Denosumab Biosimilar

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​​​​​​​On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai...more

Orrick, Herrington & Sutcliffe LLP

Treasury Publishes Final Outbound Investment Restrictions With Focus on Tech Sector and China

On October 28, 2024, the U.S. Department of the Treasury issued its final outbound investment rule, which implements Executive Order 14105, prohibiting certain outbound investments by U.S. persons in Chinese and China-related...more

Latham & Watkins LLP

Hong Kong Publishes Code of Conduct for ESG Ratings and Data Products Providers

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On October 6, 2024, the Hong Kong Code of Conduct for ESG Ratings and Data Products Providers (VCoC) was published to establish and promote a consistent, interoperable, and proportionate voluntary code for providers offering...more

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