Sygnature Discovery

APRIL 7, 2025

This translates into a better-performing end-product, enabling your success. Design, Make, Test, Analyze Whilst not traditionally considered during antibody development (and, by extension, ADC development), we b ring small molecule th inking to large molecule discovery. Big ADC problem?

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Codon

FEBRUARY 13, 2025

The issue in enzyme design, then, isn’t so much about getting initial positioning of the reactive groups, but orchestrating a sequence of structural shifts needed for catalysis: guiding substrates into place, stabilizing intermediate states, and releasing products efficiently.

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LifeSciVC

APRIL 24, 2024

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. and whether a molecule’s pharmacology can help to mitigate safety risk. in liver, in CNS)?

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Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. 3D rendering of Antibody Drug Conjugate Molecules.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. Blood 129(13): 1823-1830.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. 8 This is not the only point of interest. We hope it was a useful two-parter!

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The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . The agreement encompasses Lead Pharma’s entire pipeline.

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The Pharma Data

JULY 29, 2021

Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), and Kumquat Biosciences today announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses.

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Covalent Modifiers

NOVEMBER 7, 2023

Many previous studies have shown that 14-3-3 interactions with specific phosphorylated substrate proteins can be enhanced through small-molecule natural product or fully synthetic molecular glue interactions.

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DrugBank

JULY 24, 2024

These multifunctional small molecules are like tiny spies, hijacking the body’s natural protein degradation system to remove unwanted proteins. Multifunctional Small Molecules and Peptides Beyond PROTACs, there are other exciting tools in the new drug discovery toolbox.

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DrugBank

MAY 15, 2024

Researchers are experimenting with biologics—larger biological molecules that can do things small molecules can't, like targeting larger, more complex structures on cell surfaces or even inside cells. These methods could bypass the need to directly target these proteins with traditional drugs.

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thought leadership

SEPTEMBER 20, 2023

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category. A peptide is any polymer with 40 or fewer amino acids.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

We wrote about 2023’s Recommended Acceptable Intake Limits for Nitrosamine Drug Substance Related Impurities (NDSRIs) , which also advised on how to review drug products and take appropriate action. First, firms should undertake risk assessments of their APIs, finished products, and products under approved or pending applications.

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Small Molecule FDA Production Drugs 105

DrugBaron

FEBRUARY 7, 2022

Finding small molecule drugs is much harder than finding a needle in a haystack – discovering the right arrangement of atoms to bind precisely to a protein target to elicit a particular response is a problem of vast dimensionality. Yet the situation with small molecules is even worse.

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Drug Target Review

OCTOBER 11, 2023

In those with CMT1A, over-production of a protein called PMP22 damages the nerves that supply the arms, hands, legs and feet, leading to muscle weakness or paralysis, problems with balance and loss of sensation. Autophagy boosters, in contrast, are conventional small molecule drugs.

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ASPET

SEPTEMBER 16, 2024

We further demonstrate that daily oral treatment with a novel mitofusin activator derived from the natural product piperine can reverse these neurological phenotypes. Here, we describe motor and sensory neuron dysfunction characteristic of clinical CMT type 2A in a CRISPR/Casp-engineered Mfn2 Thr105Met (T105M) mutant knock-in mouse.

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The Pharma Data

JANUARY 19, 2021

This milestone supports the transition of Aptorum Group to a clinical-stage company and reflects the potential of our scientific rigor and novel approach of our products. We are dedicated to delivering novel therapeutics in the field of growing unmet medical needs of infections starting with Staphylococcus aureus.”. About ALS-4.

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Drug Target Review

JULY 23, 2024

This laid the groundwork for my career in drug discovery using novel modalities like small molecule inhibitors, antibodies, RNA interference (RNAi) and, currently, small molecule protein degraders – which are opportunities to change how we think about medicines.

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LifeSciVC

JANUARY 16, 2024

The past year has seen an explosion in “fast follower” approaches to improve on existing target product profiles for select mechanisms, and was exceptionally apparent for antibodies and other biologics. Small molecule GLP1s? small molecules continue to be enthusiastically funded even at the discovery stage.

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Drug Target Review

OCTOBER 4, 2023

Groundbreaking strategies like proteolysis-targeting chimeric molecules (PROTACs) are also being explored. 6 Combining the effect of payloads with different mechanisms of action – an approach that revolutionised small molecule chemotherapy – also holds the promise of enhanced therapeutic activity for ADCs.

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The Premier Consulting Blog

NOVEMBER 20, 2024

It ensures that a production process consistently yields products of predetermined quality and safety. In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial small molecule or biologic product to expedite product availability for patients.

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Broad Institute

SEPTEMBER 23, 2024

The team hopes to ultimately create a comprehensive protocol that would allow researchers to optimize every component of an mRNA drug, achieving therapeutic control previously only possible in more traditional small molecule drugs. "We and Virginia Cabot Associate Professor of Chemistry at MIT.

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LifeSciVC

AUGUST 5, 2024

We are constantly reminded how we are in the midst of an artificial intelligence revolution of the drug development process which promises to completely transform how we develop drugs with increases in productivity of an order of magnitude or more. a company with the strongest pipeline in the entire industry.”

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Drug Target Review

APRIL 7, 2025

Investigational products with novel mechanisms of action are also assessed for safety in unique ways, creating complexities that can be more dynamically and effectively monitored using biologically relevant biomarkers.

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Drug Target Review

NOVEMBER 1, 2023

ATX is mainly involved in phospholipidic metabolism and the production of extracellular lysophosphatidic acid (LPA) from lysophosphatidylcholine (LPC). Autotaxin has lysophospholipase D activity leading to tumor cell growth and motility by lysophosphatidic acid production. Cancer Metastasis Rev. 2018 Sep;37(2–3):509–18. 2017;2017:1–15.

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Clinical Trials Trials Small Molecule Disease 134

FDA Law Blog: Biosimilars

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

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FDA Law Blog: Biosimilars

AUGUST 27, 2024

Everyone in the life sciences industry must be well-versed in the regulatory components and intellectual property nuances integral to patenting products. This program lays the groundwork for understanding the patent life cycles of biopharmaceutical products and business development plans. Hyman, Phelps & McNamara, P.C.

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Small Molecule FDA Regulations Science 59

The Pharma Data

JANUARY 5, 2021

Durham, North Carolina-based Ribometrix announced a strategic collaboration deal with Genentech , a Roche company, to identify and advance novel RNA-targeted small molecule therapeutics. This is because many proteins do not have small-molecule binding sites. This is not the first deal for RNA therapeutics for Genentech.

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RNA Small Molecule DNA Licensing 52

ProRelix Research

NOVEMBER 23, 2022

Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. […].

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The Strateos Blog: Drug Discovery

MARCH 18, 2022

Director of Product Management, Strateos. Product Manager, Strateos. Strateos had the pleasure of participating at the PharmaIQ Live: Smartlab Digital 2022 conference held between March 8-9th, which focused on the potential of Lab 4.0 strategies to increase the speed, efficiency and reduce the cost of the drug discovery process.

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Small Molecule Laboratories Production Drugs 52

Drug Target Review

OCTOBER 23, 2024

Technologies for the rapid and efficient testing of small molecules and biologics have greatly accelerated drug discovery. Intermediate-sized molecules such as macrocycles combining the beneficial properties of both small molecules and biologics may enable the targeting of currently undruggable targets.

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Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant protein production.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

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The Pharma Data

JULY 12, 2021

Orelabrutinib is a Phase 2 oral small molecule Bruton’s tyrosine kinase inhibitor with high selectivity and the ability to cross the blood-brain barrier InnoCare to receive a $125 million upfront payment and is eligible to receive potential development and commercial milestone payments. Biogen Inc.

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The Pharma Data

JANUARY 25, 2021

–( BUSINESS WIRE )– Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced that the U.S. 26, 2021 13:00 UTC. FREDERICK, Md.–( About VLX-1005. Source link.

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Conversations in Drug Development Trends

MAY 30, 2024

was withdrawn, rendering it unapproved for patient use, based on negative review comments by the Committee for Medicinal Products for Human Use. Other researchers are investigating approaches that use AAV-mediated trophic support and antibody-based therapies, such as vaccines and small molecule drugs, to modify various protein expressions.

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DrugBaron

JANUARY 31, 2024

Want to know if your AI-identified tweaks to the productivity of your chemical plant do indeed improve output? But providing an incremental boost to productivity, finding molecules (small or large) that conventional approaches couldn’t find, for example. Just ask a human and you know within seconds.

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