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Knobbe Martens

Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma

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On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...more

Holland & Knight LLP

Holland & Knight Health Dose: May 13, 2025

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U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2025

Great thinkers have sought for centuries to convey a crucial truth about humanity’s interconnection. As the poet John Donne wrote: “No man is an island, entire of itself; every man is a piece of the continent, a part of the...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

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

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Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Womble Bond Dickinson

Unlocking the Secrets of the Endocannabinoid System: A New Frontier in Therapeutic Cannabis Research for Adolescents

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Humans possess several well-established bodily systems, including the sympathetic nervous system, the central nervous system, and the endocrine system. A relatively recent discovery is the endocannabinoid system (ECS)....more

Hogan Lovells

FDA announces public meeting on pediatric exclusivity and drug development

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Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - January 2025

New Year’s is receding fast in the rearview mirror. And for many of us, our sincere resolutions about losing weight and getting fitter are also fading fast. But there’s good news for helping us renew our commitment to...more

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

Ropes & Gray LLP

[Podcast] Non-binding Guidance: Clinical Trial Diversity in Focus

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On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on...more

Morgan Lewis - As Prescribed

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more

Hogan Lovells

2024 Life Sciences & Health Care Horizons

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While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

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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

Womble Bond Dickinson

An Update on Medical Research and Legal Battles for Psilocybin

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Scientists continue to research psilocybin as an alternative treatment for multiple neuropsychiatric disorders, including anxiety, depression, and PTSD. We previously highlighted this research in 2021. One area of research is...more

Holland & Knight LLP

Holland & Knight Health Dose: January 24, 2024

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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

Hogan Lovells

JPM2024: Impact of China’s HGR Rules on clinical trials and scientific studies involving China sites

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Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more

Foley & Lardner LLP

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

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On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more

Gardner Law

FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs

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Lastly, there are several clinical factors the Agency encourages sponsors to consider. One way psychedelics differ from other drugs is that the use of a traditional placebo as a control may be challenging, as an active drug...more

Husch Blackwell LLP

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

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On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - June 2023

Medical experts are rethinking obesity, one of the major harms to Americans’ health. After investigating why heavy patients after bariatric surgeries lose significant weight — and tend to keep it off — researchers have...more

Epstein Becker & Green

FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more

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