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FDA Returns Disappointing News for ALS Stem Cell Therapy

PLOS: DNA Science

Remove MSCs from a person with ALS, stimulate them to release the correct brew of neurotrophic factors, then return the doctored cells into the patients spinal fluid, where they should bathe neurons and their supportive glial cells with the nurturing factors.

Therapies 100
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How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

Among the barrage of drug ads for cancer, diabetes, weight loss and more are those for Lume , a “doctor-developed whole body deodorant.” ” The Patent Trail Rather than relying on social media, company websites, and testimonials, I consulted the Patent and Trademark database to reconstruct the story of invention.

Disease 83
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Another Reason Why The FDA, Not Litigants, Approves Products

Drug & Device Law

3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). 2023) (“ AHM II ”). Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6. See AHM I , 2023 WL 2825871, at *4 n.9 See AHM I , 2023 WL 2825871, at *4 n.9 FDA , 78 F.4th 4th 210 (5th Cir.

FDA 59
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W.D. Wash. Nixes Failure to Warn Claim Under Learned Intermediary Doctrine

Drug & Device Law

2023 WL 8717570 (W.D. 18, 2023). 2023 WL 8717570, *3. Plaintiffs had no evidence to rebut the treater’s clear testimony. The best group of legal wonks there is. Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co.,

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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GranuFlo/NaturaLyte MDL Substantive Rulings – Better Late Than Never

Drug & Device Law

3d , 2023 WL 5807340 (D. G/N , 2023 WL 5807340, at *1. G/N , 2023 WL 5807340, at *9 (plaintiffs’ experts “conducted no independent studies” and “explicitly relied on” the memo as the basis of their opinions). No “treating doctor[s] would have done something differently had they been forewarned.” Until a little while ago.

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S.D. Alabama Puts Surgeons Before Sales Representatives

Drug & Device Law

Defining “inconsistency” liberally, plaintiffs try to use sales reps to get around the learned intermediary doctrine often without much more evidence than that the sales rep visited the prescribing doctor. A step in the right direction of keeping the doctors in the foreground of the analysis. Depuy Orthopaedics, Inc. LEXIS 54471 (N.D.