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Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Womble Bond Dickinson

Financing Headwinds and the Future of Cell Cultivated Meat

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The cell cultivated meat industry has had its difficulties with funding, technology and regulatory barriers and the roller coaster ride is not over. In 2021 and 2022, $1.6 billion in venture capital investments went into the...more

Goodwin

New Momentum for a Time-Limited Conditional Approval Pathway for Rare Disease Drugs

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On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). ...more

Foley Hoag LLP - Cannabis and the Law

ALJ Hearing on Rescheduling Faces Delay Over Witness Standing

The U.S. Drug Enforcement Administration (DEA) is facing a minor delay in a crucial hearing initially scheduled for December 2, 2024, regarding the rescheduling of cannabis under federal law. Chief Administrative Law Judge...more

BCLP

U.S. Supreme Court to Hear Consequential Case Concerning Public Companies’ Risk-factor Disclosures

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The U.S. Supreme Court has scheduled argument for November 6, 2024 in an important case involving risk-factor disclosures of public companies. At issue is whether a company’s risk disclosures can be treated as false or...more

Sheppard Mullin Richter & Hampton LLP

CMS Continues to Plan AHEAD Amid Rising Healthcare Costs

On October 28, 2024, the Centers for Medicare & Medicaid Services (“CMS”) announced the latest states to participate in the voluntary state total cost of care (“TCOC”) model: the All-Payer Health Equity Approaches and...more

Polsinelli

SEC Penalties Relating to Cybersecurity Disclosures

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On October 22, 2024, the Securities and Exchange Commission (“SEC”) charged four current or former publicly traded companies with disseminating materially misleading disclosures regarding cybersecurity risks and actual...more

Eversheds Sutherland (US) LLP

Opening up about AI: OSI defines open source AI

Open Source Initiative (OSI) has provided its first definition of open source artificial intelligence. A California public benefit corporation, OSI has been defining and certifying open source software for over twenty years,...more

Carlton Fields

Penn State Settlement Shows Growing Cybersecurity Risks for Schools That Contract With Government Agencies on Sensitive Matters

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Penn State recently agreed to pay $1.25 million to settle allegations of False Claims Act violations related to its cybersecurity controls after a whistleblower alleged that the university failed to adhere to cybersecurity...more

A&O Shearman

Federal Circuit Affirms PTAB Unpatentability Findings Regarding Network Security Patents

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On October 31, 2024, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion affirming the final written decisions of the Patent Trial and Appeal Board (“PTAB”) finding that two of Centripetal Network,...more

Goodwin

Amgen Launches Its Aflibercept Biosimilar In the U.S.

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​​​​​​​After the Federal Circuit’s denial last month of Regeneron’s motion for an injunction pending appeal, seeking to prevent Amgen from launching its aflibercept biosimilar, Amgen announced on its Q3 earnings call last...more

Venable LLP

FDA Accepts aBLAs for Prolia® / Xgeva® Biosimilars from Organon and Teva

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On October 30, 2024, Organon announced the FDA acceptance of its aBLA for HLX14, a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). Organon licensed the commercialization rights for HLX14 in the U.S. from Shanghai...more

Wiley Rein LLP

Dissenting Commissioners Criticize SEC’s Latest Cybersecurity Disclosure Cases

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Continuing its controversial and aggressive approaches to cybersecurity, the U.S. Securities and Exchange Commission (SEC) recently charged four current and former public companies for purportedly “materially misleading...more

WilmerHale

Biden Administration Finalizes Controls on U.S. Investment in China

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On October 28, the Biden Administration released its long-awaited final rule to restrict U.S. investment in China. This outbound investment regime, which is effective January 2, 2025, will impact all U.S. companies and...more

Baker Botts L.L.P.

Aligning AI Development with White House Safety and Security Standards

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A recent White House memorandum on AI reminds U.S. AI companies that a more measured approach—prioritizing safety, security, and trustworthiness—will yield long-term benefits, especially in light of the evolving regulatory...more

Womble Bond Dickinson

Recent FCA Investigations at Universities: A Closer Look at Cybersecurity Compliance

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In recent years, the U.S. Department of Justice has ramped up its examination of cybersecurity compliance among federal contractors, with a particular focus on academic institutions....more

Morrison & Foerster LLP

The Future of Section 230: Protection Against Product Liability Claims?

Courts around the country are grappling with Section 230 of the Communications Decency Act. Section 230 generally shields online platforms from liability for content posted by third-party users, but courts are now deciding if...more

Erise IP

Eye on IPRs, October 2024: USPTO Issues Final PTAB Procedure Rules

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Every month, Erise’s patent attorneys review the latest inter partes review cases and news to bring you the stories that you should know about: USPTO Issues Final Rules on PTAB Procedure - The U.S. Patent and...more

Robins Kaplan LLP

Exeltis USA, Inc. v. Lupin Ltd. - Slynd® (drospirenone)

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Case Name: Exeltis USA, Inc. v. Lupin Ltd., Civ. No. 22-434-RGA, 2024 WL 4040470 (D. Del. Sept. 4, 2024) (Andrews, J.)....more

Foley & Lardner LLP

Cancer Drugs: Clinical Trial Issues for Antibody Drug Conjugates (ADCs)/Antibody Therapeutics

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Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while...more

A&O Shearman

European Securities and Markets Authority Publishes First Annual Report on EU Carbon Markets

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The European Securities and Markets Authority has published its first annual report on EU carbon markets. The report delivers insights into the functioning of the EU Emissions Trading System market. Key findings highlighted...more

McDermott Will & Emery

New Fact Sheet Highlights ASTP’s Concerns About Certified API Practices

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On October 29, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP) released a fact sheet titled “Information Blocking Reminders Related to API Technology.” The fact...more

Husch Blackwell LLP

NYDFS Warns Against the Threat of Accidentally Hiring North Korean Remote IT Workers

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Keypoint: The New York State Department of Financial Services (NYDFS) issued an industry letter outlining the threats posed to U.S. companies who hire remote technology workers linked to North Korea and may embezzle funds...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond...

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Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Igor Jablokov, an entrepreneur, former IBM director, and pioneer of the artificial intelligence industry who has been involved in several...more

Dechert LLP

SEC Division of Examinations Releases 2025 Priorities

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The SEC’s Division of Examinations (EXAMS) published its report on 2025 Examination Priorities on October 21, 2024. Areas such as artificial intelligence (AI), cybersecurity and crypto assets are top of mind for EXAMS,...more

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