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Venable LLP

FDA Approves First Interchangeable Biosimilar of Xolair®: Celltrion’s Omlyclo® (omalizumab-igec)

Venable LLP on

On March 7, 2025, the FDA approved Celltrion’s Omlyclo® (omalizumab-igec), the first interchangeable biosimilar of Genentech’s Xolair® (omalizumab). Omlyclo® was approved for all of Xolair®’s approved indications, including...more

McCarter & English, LLP

Federal Courts Decide on FCA Claims Actions

There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more

Husch Blackwell LLP

Raising Capital in a Highly Regulated Market

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For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more

ArentFox Schiff

Federal Circuit Affirms ImmunoGen Patent Obviousness

ArentFox Schiff on

In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more

Foley & Lardner LLP

GLP-1 Receptor Agonists and Patent Strategy: Securing Patent Protection for New Use of Old Drugs

Foley & Lardner LLP on

GLP-1 receptor agonists (GLP-1RAs) were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

Foley & Lardner LLP on

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

Wilson Sonsini Goodrich & Rosati

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

Epstein Becker & Green

Limits on Physician Noncompete Agreements: Navigating New State Laws and Legislation

Epstein Becker & Green on

As anticipated, following the end of the Federal Trade Commission’s proposed rule prohibiting employer noncompetes, states have ramped up their efforts toward limiting noncompete agreements, including some states that have...more

TNG Consulting

Examining the State of Behavioral Intervention and Threat Assessment: Part Two

TNG Consulting on

In part one of this Tip of the Week series, we explored insights from the 2024 State of the Field Survey related to the structural aspects of team organization and formation. Now, in this second part, we turn our attention to...more

Akerman LLP - Health Law Rx

No (Public) Comment: HHS Rescinds Policy on Public Participation in Rulemaking

The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The...more

Littler

Arkansas Bans Physician Non-Compete Agreements

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On March 4, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law Senate Bill 139, now Act 232 (the “Act”), which amends the state’s non-compete statute to provide that non-compete covenants that “restrict the right...more

Hutchison PLLC

Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley

Hutchison PLLC on

What if the key to understanding and improving brain health lies in a breakthrough approach to neurodata? For Rob Cooley, founder and CEO of Nuream, unlocking the potential of brainwave data has the power to transform...more

Husch Blackwell LLP

Hospice Insights Podcast - Psychedelics and End of Life Care: Understanding the Legal Landscape

Husch Blackwell LLP on

There has been a lot of buzz around psychedelics, and particularly their potential usefulness in treating existential suffering at the end of life. Husch Blackwell was the first law firm in the country to establish a...more

Holland & Knight LLP

Holland & Knight Health Dose: March 11, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Mintz

[Podcast] Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

Mintz on

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is...more

McDermott Will & Emery

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

McDermott Will & Emery on

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

A&O Shearman

First Circuit Ruling Requiring “But-For” Causation In FCA Kickback Claims Deepens Circuit Split

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In an opinion that may complicate the U.S. Department of Justice’s (“DOJ”) efforts to enforce the False Claims Act (“FCA”), the U.S. Court of Appeals for the First Circuit held in a unanimous opinion on February 18, 2025 that...more

Health Care Compliance Association (HCCA)

$1.5M Warby Parker Fine a Holdover; OCR Focuses On Men in Sports, Antisemitism, ‘Biological Truth’

Nearly six years to the day that Warby Parker reported a breach affecting nearly 200,000 individuals, the HHS Office for Civil Rights (OCR) imposed a $1.5 million fine on the eyewear giant. Investigated by OCR under the Biden...more

A&O Shearman

Eastern District Of Pennsylvania Grants Defendants’ Motion To Dismiss Allegations Of Tying Discounted Drug Prices With Third-Party...

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On February 26, 2025, Judge Mia Perez of the United States District Court for the Eastern District of Pennsylvania granted defendants’ motion to dismiss plaintiff’s Sherman Act and Clayton Act claims, though the plaintiff had...more

McDermott Will & Emery

HHS OCR Investigates Medical Schools and Hospitals for Race- or Sex-Based Programs

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On March 7, 2025, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it would begin investigating four medical schools and hospitals pursuant to President Donald Trump’s...more

Groom Law Group, Chartered

This Week From the Hill (March 9 – 15, 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

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

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In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

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