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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 65
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FDA Returns Disappointing News for ALS Stem Cell Therapy

PLOS: DNA Science

The only treatment for ALS is a drug, Riluzole , taken as a tablet or a film. 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.

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Another RICOdiculous Decision

Drug & Device Law

2019) (“ PATDC82 I ”), because the third-party payor (“TPP”) plaintiffs were allowed to misuse RICO to pursue what was essentially a garden variety inadequate warning case – that the drug Actos increased the risk of bladder cancer. It seems quite logical that Plaintiffs would have paid for a different drug to treat patients’ diabetes. . . .

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So Long to All that Junk

Drug & Device Law

As we prepare to greet 2023, we find ourselves assuming the Janus-ian posture of simultaneously looking backward and forward. Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.)

FDA 59
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Federal Court Calls Out—and Enjoins—Anti-Trans Bigotry

Drug & Device Law

Ladapo , 2023 WL 3833848 (N.D. 2023), appeared in our daily search results because it briefly addresses off-label use of prescription drugs. 2023 WL 3833848, at *3. Doe , 2023 WL 3833848, at *2. 2023 WL 3833848, at *2. 2023 WL 3833848, at *2. We couldn’t have said it better ourselves.

Doctors 122
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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 ”). Considering the rigorousness of this process and the due process interests of drug sponsors, Congress also mandated by statute a process for withdrawal or suspension of an FDA approval decision − a process the Fifth Circuit circumvented.

FDA 59
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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.