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Venable LLP

Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar

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On January 27, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT05, a proposed biosimilar of Janssen’s Simponi® / Simponi Aria® (golimumab)....more

Ropes & Gray LLP

New York's Health Information Privacy Act Aims to Strictly Regulate Consumer Health Data

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On January 22, 2025, the New York State Assembly and Senate rapidly passed the wide-ranging New York Health Information Privacy Act (“NY HIPA”). If not vetoed by Governor Kathy Hochul, NY HIPA would be the fourth enacted...more

Vicente LLP

Cannabis Rescheduling Hearings Postponed: How Did We Get Here and What Happens Next?

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The much-anticipated hearings on the proposed rulemaking to reschedule cannabis, which were scheduled to begin on January 21, have been postponed for at least three months as a result of an appeal granted by DEA...more

Bradley Arant Boult Cummings LLP

False Claims Act: 2024 Year in Review

Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2024 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. ...more

Jones Day

DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

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The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

Polsinelli

Federal Grant Funding: A Thaw in the Freeze?

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Last week was a roller coaster ride for health care providers and other recipients of federal grant funding. Here’s a quick recap of everything that’s happened since our last e-alert...more

Bodman

Resolutions for Healthcare Providers: Part 1 of 2 – Cybersecurity, Privacy and HIPAA Compliance

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As the new year begins, it is useful to review your practice’s processes and policies to ensure that the practice operates with efficiency and remains compliant with ever-changing healthcare regulations....more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 10 - January 2025

The Georgia General Assembly got off to a fast start on Monday with the State Senate taking up its first substantive measures of the session before both bodies filled the afternoon with committee hearings. But before...more

A&O Shearman

Tenth Circuit Rejects Surgical Assistants’ Appeal In Surgical Credentials Monopolization Case

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On January 21, 2025, the Tenth Circuit Court of Appeals affirmed the United States District Court for the District of Colorado’s dismissal of the Association of Surgical Assistants’ (ASA) challenge to the National Board of...more

Bass, Berry & Sims PLC

The Future of Telemedicine Prescribing Comes Into Focus: New Final and Proposed Rules

On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in...more

Robins Kaplan LLP

Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

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Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.)  Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...more

Holland & Knight LLP

RFK Jr.'s 2 Days in the Spotlight: Food Additives, Vaccines and Clinical Trials

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Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more

Foster Garvey PC

FDA Proposes New Front-of-Pack Nutrition Label

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On January 14, 2025, the Food and Drug Administration (FDA) proposed a new requirement for all packaged foods to have a front-of-package (FOP) nutrition label. The FDA’s position is that the FOP label would provide consumers...more

Haug Partners LLP

The Sole Meaning of “Solely”: Supreme Court Denies Certiorari on Edward Life Sciences v. Meril Life Sciences Pvt. Ltd. and Permits...

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This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more

Groom Law Group, Chartered

This Week From the Hill (February 2 – February 8, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Faegre Drinker Biddle & Reath LLP

China Issues Final Compliance Guidelines in Regulating the Medical Industry

On January 10, 2025, China’s State Administration for Market Regulation (SAMR) officially released the Compliance Guidelines on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises (the Guidelines). This...more

Blake, Cassels & Graydon LLP

Des développements législatifs touchent le secteur québécois des soins de santé

Une nouvelle politique fédérale et des modifications législatives au Québec amènent des changements au sein du secteur québécois des soins de santé. Un éventail varié d’entreprises dans ce secteur pourrait devoir s’adapter en...more

Sheppard Mullin Richter & Hampton LLP

Four Takeaways from the Orthopedics Today Conference 2025

Sheppard Mullin partners, Cyrus Abbassi and Leonard Lipsky, served as panelists at the annual Orthopedics Today Conference in Kauai, Hawaii, held in January 2025. During a spirited discussion with various stakeholders in the...more

McDermott Will & Emery

Human Trafficking Monitoring for Telehealth Providers

Telehealth providers are uniquely positioned to monitor for human trafficking when interacting with patients. Survivor records indicate that health services are among the most common points of access to help trafficked...more

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

Groom Law Group, Chartered

CMS Proposes Update to Simplified Prescription Drug Creditable Coverage Determination Methodology

When Congress created the Part D benefit for Medicare beneficiaries, it also required group health plan sponsors and certain other entities to notify Medicare-eligible participants and the Centers for Medicare & Medicaid...more

Goodwin

FDA Approves Celltrion’s AVTOZMA (tocilizumab-anoh)

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​​​​​​​On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®....more

Mintz

[Podcast] Health Law Diagnosed – New Year's Gratitude

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In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of...more

Womble Bond Dickinson

Fraud Section’s 2024 Year in Review Shows Enforcement Uptick

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The Fraud Section of the U.S. Department of Justice’s Criminal Division published its Year in Review last month, which showed an uptick for white collar enforcement in foreign corruption, financial and health care fraud. The...more

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