Remove 2009 Remove DNA Remove Pharmacokinetics
article thumbnail

TACACICLIB, AUR-102, AURIGENE

New Drug Approvals

Nature Cell Biology, 11, 1275 – 1276, 2009), whilst different tumors appear to require some, but they are independent of other interphase CDKs (CDK2, CDK4 , CDK6). CDK7 also plays a role in transcription and possibly in DNA repair. 27, 6012-6018, 2009; Christian et al., 3, S179-S185, 2009). Mar 23;25(6):839-50.

article thumbnail

ATUZAGINSTAT

New Drug Approvals

gingivalis DNA was detected in postmortem cortices from people with AD and healthy controls, and in CSF of AD patients ( Jan 2019 news on Dominy et al., gingivalis infection led to the appearance of bacterial DNA in the brain, increased brain Aβ42 production, neuroinflammation, and hippocampal degeneration. 2009 Mar;77(3):1246-61.

article thumbnail

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.,