Duane Morris

Duane Morris's articles

  1. Life Sciences

What Spas Need to Know – Duane Morris Life Sciences Law

The global market for intimate wellness products is expected to grow to $81.4 billion by 2028, up from $51.9 billion in 2021, according to recent market research reports. Once taboo, or the topic of hush-hush conversations, intimate wellness brands are increasingly crossing over into mainstream wellness marketing, collaborating with well-known fashion […]
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  1. Life Sciences

FDA’s Final Guidance on Decentralized Clinical Trials Published – Duane Morris Life Sciences Law

On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using […]
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  1. Life Sciences

FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes – Duane Morris Life Sciences Law

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug […]
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  1. Life Sciences

House Oversight Committee Gives Pharmacy Benefit Managers Deadline to Correct Congressional Record of Allegedly Fraudulent Statements

On August 28, 2024, the U.S. House Committee on Oversight and Accountability issued letters to executives of three of the nation’s largest pharmacy benefit managers (PBMs), accusing them of providing false testimony before Congress. Each letter outlines the allegedly false statements and the evidence that the statements contradict. They also outline […]
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  1. Life Sciences

Artificial Intelligence in Medtech – Duane Morris Life Sciences Law

Given the vast amounts of data available, including raw measurements, diagnostic information, treatment plans, and regulatory guidelines, the biomedical technologies sector stands to gain immensely from artificial intelligence (AI), particularly machine learning (ML). ML, at its core, learns from training datasets to identify patterns, which can then be applied to new […]
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  1. Life Sciences

Obviousness-Type Double Patenting Immunity for First-Filed, First-Issued and Later-Expiring Patent in a Family – Duane Morris Life Sciences Law

Recently, the relationship and intersection between obviousness-type double patenting (ODP) and any awarded Patent Term Adjustment (PTA) and/or Patent Term Extension (PTE) has received significant attention. The United States Court of Appeals for the Federal Circuit held in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023), that PTA and PTE, being codified […]
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  1. Life Sciences

Induced Infringement Suit Against Generic Pharma Revived Despite Skinny Label Compliance – Duane Morris Life Sciences Law

In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone […]
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  1. Life Sciences

Federal Trade Commission Poised to File Suit Against Pharmacy Benefit Managers Based on Unlawful Medication Pricing – Duane Morris Life Sciences Law

On July 10, 2024, multiple media sources reported that the Federal Trade Commission intends to file suit against the nation’s three largest pharmacy benefit managers over​ allegations of improper pricing in connection with their negotiations with drug manufacturers that dramatically increased prices for consumers and lined the PBMs’ pockets with lucrative […]
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  1. Life Sciences

Doing No Harm but Exporting Without Appropriate License Can Violate Regulations – Duane Morris Life Sciences Law

By Brandon A. Chan, Ph.D., and Brian Goldstein On June 24, 2024, the Department of Commerce’s Bureau of Industry and Service (BIS) imposed an administrative penalty on Indiana University (IU) as part of a settlement agreement following IU’s discovery and self-disclosure to BIS that its Bloomington Drosophila Stock Center engaged in the export of materials […]
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  1. Life Sciences

The Changing Beauty Regulatory Landscape – Duane Morris Life Sciences Law

Duane Morris attorney Kelly Bonner was quoted in an article in WWD on June 25, 2024. “A big deadline in the beauty and personal care regulatory landscape is fast approaching, with much more to come — although some experts believe this still isn’t enough. Under the Modernization of Cosmetics Regulation Act, or MoCRA, passed […]
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  1. Life Sciences

FDA’s New Rule Regulates Lab-Developed Tests Under FD&C Act – Duane Morris Life Sciences Law

On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act (FD&C Act). LDTs have increased in volume, complexity and […]
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  1. Life Sciences

How They’ll Have an effect on Patent Prosecution Methods – Duane Morris Life Sciences Legislation

The USPTO is soliciting feedback relating to its proposed charge will increase for fiscal yr 2025. Written feedback have to be acquired on or earlier than June 3, 2024, to make sure consideration. Thus, it’s essential that each in-house attorneys and outdoors counsel assessment and contemplate how these adjustments, a few […]
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