The Pharma Data

DECEMBER 29, 2020

Proceeds will be used to fund LyGenesis’s Phase 2a clinical trial with a first patient in targeted for early 2021, as well as to push forward on their other cell therapies using lymph nodes as bioreactors to regrow functioning organs, including pancreas, kidney, and thymus regeneration. and Longevity Vision Fund.

Therapies 52

Therapies FDA Disease Trials 52

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. .” ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .” fit in this definition.

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FDA Science Regulations Production 40

Drug & Device Law

DECEMBER 21, 2023

Takeda Pharmaceutical Co. , That makes no sense either, because at the time of FDA approval, not to mention before FDA approval, there is, by definition, no “newly acquired information” beyond what the FDA considered in its approval decision. Luitpold Pharmaceuticals, Inc. 3d , 2023 WL 4191651 (C.D. We castigated CPAP here.

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FDA Approval FDA Drugs Production 52

Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

JANUARY 15, 2024

A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion. Ethicon, Inc. ,

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Compliance Government FDA Compliance Production 52

Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). Boehringer Ingelheim Pharmaceutical, Inc. Janssen Pharmaceuticals, Inc.

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Testimonials Production Drugs Pharmaceuticals 59

Drug & Device Law

JUNE 23, 2023

We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. Plaintiff Adams’ “sworn testimony and plaintiff fact sheet” established that she blew the statute of limitations by some eight years. This wasn’t a close case. And hair loss is a well-known consequence of chemotherapy.

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Testimonials Government Treatment Production 59