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#WhyIScience Q&A: A research scientist uses mass spectrometry to discover how metabolites affect human health

Broad Institute

Deik moved to the Broad in 2009 and joined Clish as a biochemist in the Platform, where she also serves as lab manager. I run mass spectrometers daily to analyze thousands of small molecules that are present in a variety of samples, such as plasma, a mouse liver, or a cell culture. I also serve as our group's lab manager.

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FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA replied that its definition of strength including concentration was clear even in 2009. mg) and the concentration (e.g., mg/mL) for liquid parenteral drug products.

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ATUZAGINSTAT

New Drug Approvals

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. 2009 Mar;77(3):1246-61. Infect Immun.

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ABY 737

New Drug Approvals

852808-04-9 ABT-737 is a small molecule drug that inhibits Bcl-2 and Bcl-xL , two members of the Bcl-2 family of evolutionarily-conserved proteins that share B cl-2 H omology (BH) domains. “Bcl-2 inhibitors: small molecules with a big impact on cancer therapy.” ABT-737 Molecular Weight 813.43 PMC 4823827.

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The Book of Nimbus

LifeSciVC

Fourteen years on, this corporate experiment has gone far beyond the initial idea, and has established an R&D engine more effective than most big pharma R&D groups at producing best-in-class small molecules against targets that matter in human disease biology. Chapter 1 – An Unreasonable Idea The year was 2009.

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ATICAPRANT

New Drug Approvals

16] [17] The compound was first patented in 2009. [18] 16] [17] The compound was first patented in 2009. [18] “LY2456302 is a novel, potent, orally-bioavailable small molecule kappa-selective antagonist with activity in animal models predictive of efficacy in mood and addictive disorders” Neuropharmacology.

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Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products. Any CMC changes (e.g.,