FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

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BMG Labtech

NOVEMBER 21, 2023

Effectors of signal transmission events Second messengers are small molecules or ions that transmit signals received at the cell surface to the inside environment of the cell (Fig.

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Small Molecule Regulations Research Cell Biology 40

Dark Matter Blog

JULY 16, 2021

My last stop at Arrakis Therapeutics is with a company targeting RNA with small molecules. Prior to that, I was CSO at RaNA Therapeutics (now Translate Bio), initially focused on targeting the function of long noncoding RNA in epigenetic regulation, and later transitioning to an mRNA therapeutics company. I obtained my Ph.D.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product.

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The Premier Consulting Blog

MAY 31, 2023

In this blog post, we outline typical elements of an IND-enabling package for a single ascending dose (SAD)/multiple ascending dose (MAD) study of an oral small molecule for a non-cancer indication with a maximum of 14 days of dosing.

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Metabolite Tales Blog

DECEMBER 13, 2023

N -glucuronidation: the human element By Julia Shanu-Wilson In our last blog of the year, we look at why N -glucuronidation of drugs is important in human drug metabolism. Conjugation of small molecule drugs to glucuronic acid is catalysed by several UGTs to frequently form N – and O -glucuronides. Derun Li, David L.

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Small Molecule Metabolic Stability Treatment Drugs 59

LifeSciVC

DECEMBER 6, 2022

The following blog post provides some valuable real-world perspective on why this initiative is such an important breakthrough in immunology therapeutics. That can be a good thing: for example, when determining inherited traits and regulating critical cell functions.

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Small Molecule DNA Regulations Science 40

LifeSciVC

APRIL 2, 2024

By Mike Cloonan, CEO of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC An insightful piece on this blog following the JPM healthcare conference noted the “ refreshing burst of enthusiasm ” in the biotech sector. We experienced strong enthusiasm for small molecule research in the investor community.

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Science Small Molecule International Clinical Development 69

Advarra

JANUARY 11, 2024

In this blog, we examine how mRNA can impact cancer treatment, the unique challenges associated with working with mRNA, and strategies for researchers proposing mRNA-based cancer trials. Many monoclonal antibodies are used to treat cancer by targeting specific cell structures regulating cell activity, causing the death of tumor cells.

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New Drug Approvals

DECEMBER 3, 2022

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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Small Molecule Clinical Trials Laboratories Regulations 52

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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New Drug Approvals

DECEMBER 16, 2023

1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. “Small-molecule factor B inhibitor for the treatment of complement-mediated diseases” Proceedings of the National Academy of Sciences of the United States of America. Hz, 2H), 7.36−7.31

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. Boehringer’s regulatory argument got no further traction. do not help Boehringer’s case. parenteral solutions) but is not typically broken out for others (e.g.,

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FDA Biosimilars Production Regulations 59

KIF1A

JUNE 30, 2023

ScienceSaturday: Since January 2022, we have written over 70 #ScienceSaturday blog posts to share relevant and exciting scientific news with the KIF1A community. With these models established, we are preparing to test our first batch of small molecules drugs later this year!

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Small Molecule Treatment Doctors Research 52

PerkinElmer

DECEMBER 3, 2021

Small molecules that bind to allosteric sites and enhance responses to GPCR agonists are known as positive allosteric modulators (PAMS), while those that inhibit the response are known as negative allosteric modulators (NAMS). Figure reprinted from Cao A et al.1 Looking to streamline and further your GPCR research? 2021;12(1).

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Drugs Small Molecule Research Regulations 52

NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

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Clinical Trials Small Molecule Therapies Disease 52

LifeSciVC

APRIL 27, 2023

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. Our long-time clinical development lead, Bhaskar Srivastava, an M.D.

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Small Molecule Computational Chemistry Engineering Clinical Development 40

Codon

MARCH 19, 2024

When a somatic cell is reprogrammed into an iPSC, either by using Yamanaka’s method or small molecules that mimic the four proteins, the epigenomes of the reprogrammed cells are effectively “wiped clean” and reverted into a state comparable to that of an embryonic stem cell. Credit: PA Images / Alamy.

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The Premier Consulting Blog

OCTOBER 5, 2022

Premier Consulting has significant experience in process technology transfer of both small molecule APIs and biotherapeutics, including both drug substance and drug product manufacturing. Contact us today to see if partnering with Premier Consulting is right for you!

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KIF1A

MAY 31, 2024

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. You can read about her journey and first dose in our blog.

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Treatment Small Molecule International Research 52

Codon

APRIL 2, 2023

Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Read A company that uses AI to design small molecule therapeutics for cancer and immune-related conditions, called Athos Therapeutics , has gotten the green light to commence a Phase I clinical trial. Cell Systems. Fukunaga K.

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Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. Read An automated platform to make riboswitches (RNA strands that bind to small molecules and then quickly switch their structure) that can sense specific proteins. .” Nature Genetics. Read Wanna start a protein therapeutics company? Synthetic Biology.

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Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. Read An automated platform to make riboswitches (RNA strands that bind to small molecules and then quickly switch their structure) that can sense specific proteins. .” Nature Genetics. Read Wanna start a protein therapeutics company? Synthetic Biology.

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BMG Labtech

FEBRUARY 24, 2025

Protein nitration is one example that takes place on tyrosine residues which can have important consequences for the regulation of biological processes. In this blog, we look at some of the ways a microplate reader can be used to advance protein nitration and related research in the laboratory. The assay (Fig. The RAW264.7

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Codon

APRIL 16, 2023

Read Deep learning of genomic contexts predicts protein co-regulation and function. Read RIP-PEN-seq identifies a class of kink-turn RNAs as splicing regulators. Rea Chromatin context-dependent regulation and epigenetic manipulation of prime editing. 📜 Papers (* = Recommended.) BMC Bioinformatics. Schofield J.A. &

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