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Mediating BRAF-mutant melanoma resistance

Drug Target Review

Our data demonstrate that the CoREST complex is a critical mediator of the distinct melanoma phenotypes, working through the regulation of both the phenotype-defining genes MITF and AXL as well as the master regulators of epithelial-to-mesenchymal transitions (EMT) and phenotype switching in melanoma and other cancers, SNAIL/SLUG/ZEB1/ZEB2.

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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

FDA Law Blog: Biosimilars

While the Federal Food, Drug & Cosmetic Act does not explicitly define “advertisement,” FDA provides several examples in its regulations at 21 CFR § 201.1(l)(1) l)(1) (e.g.,

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BetterLife Confirms Non-controlled Status of 2-bromo-LSD with Health Canada

The Pharma Data

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

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The Art of Recruitment and Talent Development in FSPs

PPD

In many cases, these staff also seek training and coursework that develop their skills beyond what is strictly required by regulation — ensuring they not only deliver the best outcomes for the current project but are well-suited to the next project and a successful career in the field.

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Article FDA Thank You FDA makes significant qualitative changes in its final guidance on quantitative information in drug advertising

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC JUN 28, 2023 12:13 AM EDT Regulatory background The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., The FDA regulates prescription drug advertising under 21 CFR 202.1 , Prescription drug advertisements.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions.

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The Year (and a Half) in Review: 2022

KIF1A

This is one of the most foundational tools needed to prepare for upcoming clinical trials so families, scientists and regulators can identify measurable improvements in KAND symptoms as the result of new treatments. Her focus is to create a community dedicated to those raising a child with a disability in America.