News & Analysis as of

Prescription Drugs

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

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Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

Maynard Nexsen

JPMorgan Sued Over Management of Prescription Drug Benefits

Maynard Nexsen on

On March 13, 2025, several current and former participants in the JPMorgan Chase Health Care and Insurance Program for Active Employees, as well as its component Medical Plan (collectively referred to as the “Plan”) filed a...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

Foley Hoag LLP

U.S. Department of Commerce Investigates Possible Tariffs on Pharmaceuticals: Forecasting the Impact and an Opportunity to Comment

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I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more

Skadden, Arps, Slate, Meagher & Flom LLP

President Trump Issues Executive Order Intended To Lower Drug Prices

On April 15, 2025, President Trump issued the executive order “Lowering Drug Prices by Once Again Putting Americans First,” aimed at lowering the prices of prescription drugs and biologics, encouraging competition in the drug...more

Maynard Nexsen

Prescription Revolution: Trump’s Bold Move to Slash Drug Prices

Maynard Nexsen on

An Overview of the Executive Order on Lowering Drug Prices - On April 15, 2025, President Donald J. Trump signed an Executive Order aimed at reducing prescription drug prices in the United States. This order builds upon...more

Hogan Lovells

White House issues Executive Order directing efforts to lower drug prices

Hogan Lovells on

On April 15, 2025, the White House issued an Executive Order (EO) entitled “Lowering Drug Prices by Once Again Putting Americans First.” The EO directs various agencies to engage in a number of distinct efforts to lower...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

Venable LLP on

Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Brownstein Hyatt Farber Schreck

Trump Administration Takes First Steps Towards Tariffs on Pharmaceuticals

After months of signaling, the Department of Commerce disclosed on April 14 that it had begun an investigation into the national security impacts of importing pharmaceuticals, pharmaceutical ingredients and derivative...more

Venable LLP

FDA Approves Biocon’s Avastin® Biosimilar Jobevne™ (bevacizumab-nwgd)

Venable LLP on

On April 10, 2025, Biocon announced the FDA approval of Jobevne™ (bevacizumab-nwgd) as the sixth biosimilar of Genentech’s Avastin® (bevacizumab)...more

Dentons

Ep. 57 – Implementing Effective Drug Diversion Prevention Programs

Dentons on

Drug diversion can pose serious risks to patients, employees, and organizations. Any provider who stores, transports, or dispenses controlled substances should have a robust program designed to deter drug diversion and to...more

Alston & Bird

Commerce Seeks Comments on Section 232 Pharmaceutical Investigation

Alston & Bird on

Yesterday, April 16, 2025, the Bureau of Industry and Security (BIS), a bureau within the U.S. Department of Commerce, published a “Notice of Request for Public Comments on Section 232 National Security Investigation of...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

Venable LLP on

Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Downs Rachlin Martin PLLC

Mass General Brigham study offers promise that nasal spray targeting neuroinflammation could become an effective treatment for TBI

The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult.  There is no clearly...more

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

Morgan Lewis on

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

McDermott Will & Emery

This Week in 340B: April 8 – 14, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Akin Gump Strauss Hauer & Feld LLP

Lowering Drug Prices by Once Again Putting Americans First (Trump EO Tracker)

This order makes it the policy of the United States that Federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at a lower cost to...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

DLA Piper

Keeping Watch on the Inflation Reduction Act: Medicare Poses Part D Formulary Access Challenges

DLA Piper on

Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more

Searcy Denney Scarola Barnhart & Shipley

Seeking a Depo-Provera Settlement: What Patients and Families Need to Know

The costs of an intracranial meningioma diagnosis can be substantial. Not only can this diagnosis lead to a lifetime of medical bills and other costs, but it can drastically reduce patients’ quality of life as well....more

Perkins Coie

First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

Perkins Coie on

On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more

Holland & Knight LLP

CMS Final Rule on CY 2026: Policy and Technical Changes

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

Goodwin

FDA Approves Biocon Biologics’ Bevacizumab Biosimilar

Goodwin on

On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE™ (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech’s AVASTIN®.  JOBEVNE™ is a...more

Proskauer Rose LLP

Question of the Week: How are expiring patents fueling M&A in the life sciences industry?

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Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our...more

Holland & Knight LLP

Excessive Fee Cases: Not Just for Retirement Plans Anymore

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A recent wave of cases has attempted to apply the theory of liability for retirement plan excessive fee cases to health plans – specifically, arrangements with pharmacy benefit managers. Though the cases thus far have...more

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