Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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The Pharma Data

OCTOBER 19, 2020

Caris Precision Oncology Alliance members also have access to the Caris Pharmatech oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development.

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The Pharma Data

JUNE 28, 2021

Bayer’s acquisition of Noria and PSMA Therapeutics, which have nurtured Dr. Babich’s radiopharmaceutical and diagnostic technology, is an important milestone in drug development, and we look forward to the advances this collaboration can make to enhance prostate cancer therapies.”.

Small Molecule 52

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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.

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Drug Target Review

JANUARY 15, 2024

Unlike almost every other cell type (except B cells), T cells do not have the exact same chromosomal DNA sequences as other cells in the body. In previous decades, isolation, sequencing and characterisation of DNA encoding a specific TCR was laborious and technically challenging. References Robinson R, McMurran C, McCully M, Cole D.

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Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

Drug Development 52

Drug Development Disease Therapies Engineering 52

Broad Institute

OCTOBER 11, 2023

Calico, together with AbbVie, has worked with TIDE to advance some of its drug discovery and development programs and now has projects — including the PTPN2 inhibitors — in various stages of preclinical and clinical development.

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Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

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The Pharma Data

NOVEMBER 29, 2020

Compared to placebo, participants vaccinated with three HB-101 doses had: a 48 percent reduction in CMV viremia (presence of CMV DNA in the blood); a 42 percent reduction in the use of antiviral therapy; and. no CMV disease (compared to 2 out of 14 cases in the placebo group).

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Vaccine Clinical Trials Disease Therapies 40

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. 7 Recent clinical studies highlight promising developments in c-MET-targeting ADCs for NSCLC. Phuna ZX, Kumar PA, Haroun E, Dutta D, Lim SH.

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The Pharma Data

OCTOBER 26, 2020

The increase was primarily driven by higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower laboratory, travel and meeting expenses due to the COVID-19 pandemic. Organon & Co. Non-GAAP R&D expenses were $2.3

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LifeSciVC

FEBRUARY 5, 2025

Transcription factors are well-known entities they are the hairclip-shaped molecules that when activated, travel into to the nucleus, grab onto DNA, and drive the transcription of genes into proteins.

Small Molecule 67

Small Molecule Targeted Protein Degradation Regulations Disease 67

FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

For adeno-associated viral vectors, examples may include characterization of non vector DNA impurities in capsids by next-generation sequencing, vector genome size analysis, and detection of capsid amino acid modifications by mass spectrometry. It is important that sponsors do not miss an opportunity to engage with CBER on CMC topics.

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