Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.

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The Premier Consulting Blog

NOVEMBER 20, 2024

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. It ensures that a production process consistently yields products of predetermined quality and safety.

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The Pharma Data

JULY 28, 2021

Novel small molecule drug candidates will target GPR75 to potentially address obesity and related co-morbidities. The companies will evenly split research and development costs and share equally in any future potential profits. Yancopoulos, M.D.,

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Small Molecule Research Science Disease 52

LifeSciVC

JANUARY 3, 2024

There is clear precedent for such a complex-directed therapeutic approach in drug discovery. At HotSpot, we believe our proprietary Smart Allostery TM drug discovery platform affords us a unique understanding of how nature controls proteins through signaling pathways, including at the intricacies of complex formation.

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Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

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DrugBank

MAY 15, 2024

The road to developing effective drugs is fraught with both promise and challenge, particularly when it comes to what scientists call "undruggable" targets. The Evolution of Drug Discovery: From Dark Rooms to Precision Targets In the past, drug discovery often felt like a lucky guess.

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Small Molecule Molecular Biology Drugs Disease 82

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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DrugBank

JULY 24, 2024

In the constantly evolving field of drug discovery, the term “undruggable” refers to proteins and targets in the body that, until recently, were considered impossible to treat with traditional drugs. This is a game-changer, especially in the fight against cancer and other complex diseases.

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Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds. This means that we are not doing something right.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Chemical Biology and Drug Design

OCTOBER 20, 2023

Enzymes involved in glucose metabolism may be promising therapeutic targets for drug development against the pathogenic free-living amoebae. Details about the enzyme sequence and structural properties make a compelling case for designing small molecule inhibitors that are specific to the amoebae and would not affect the host enzyme.

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Covalent Modifiers

FEBRUARY 1, 2024

link] Proteins labelled site-specifically with small molecules are valuable assets for chemical biology and drug development. Nat Commun 15 , 859 (2024). In addition to protein bioconjugation, the bis-heterocyclic scaffold we report herein will find applications in synthetic and medicinal chemistry.

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Biophysical Assays Small Molecule Drug Development Production 79

Drug Target Review

SEPTEMBER 25, 2024

While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Classically, rational drug combinations are designed to target two nodes in the same oncogenic signalling pathway.

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Small Molecule Therapies Regulations Treatment 105

Drug Target Review

JULY 13, 2023

Drug discovery is a complex and vital field that continually seeks to identify new therapeutic targets and develop effective treatments. In recent years, a novel approach known as condensate biology has emerged, revolutionising the way researchers think about drug discovery and development.

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Disease Small Molecule Cell Biology Drugs 98

Drug Target Review

NOVEMBER 1, 2024

Strategies for the synthesis and development of complex active pharmaceutical ingredients While the prevalence of biologics has grown within the pharmaceutical sector over recent decades, small molecules remain important and can offer significant advantages. References [1] Clemons et al.

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Small Molecule Production Pharmaceuticals Drug Development 52

Alta Sciences

SEPTEMBER 27, 2024

This issue also covers classes of immunomodulators, including monoclonal antibodies, CAR-T cells, and vaccines; immunotherapy trials, focusing on complex study designs and diverse patient populations; and bioanalytical methods and assays, including pharmacokinetics and anti-drug antibodies (ADA).

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Clinical Trials Trials Pharmacokinetics Small Molecule 52

BMG Labtech

APRIL 16, 2024

In this blog, we take stock of progress, look at what’s in store for drug development, and give examples of ways microplate readers can help advance research into molecular glues. Conventional drug development has often focused on finding small molecules that fit the active site of a protein.

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Targeted Protein Degradation Small Molecule Drug Development Disease 40

SCIENMAG: Medicine & Health

MARCH 26, 2024

Credit: Redox Medicine […]

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Small Molecule International Drug Development Drugs 78

DrugBank

MAY 22, 2024

In the dynamic world of drug discovery, the notion of "undruggable" targets presents both a significant challenge and an intriguing frontier for researchers and pharmaceutical companies. A big part of the puzzle is selectivity—the ability of a drug to zero in on specific biological molecules without affecting others.

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Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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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.

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Molecular Biology Production Drug Development Small Molecule 87

Dark Matter Blog

JUNE 21, 2023

As a small biotech company with new technology at the frontier of the known drug discovery universe, it may feel like you’re charting a course alone in a dark, cold, and empty void with hailing frequencies open, but with no incoming transmissions. But you would be wrong. This latter course is Arrakis’ strategy.

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Broad Institute

NOVEMBER 2, 2023

Combining Broad’s expertise in cancer biology and state-of-the-art drug discovery methods with Bayer’s expertise in drug development greatly increases our power to bring transformative medicines to cancer patients.” “We Through this alliance, Broad and Bayer have done just that.

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PPD

OCTOBER 18, 2023

As exponential growth and global expansion continue in both the biotech and pharmaceutical industries, it is critical for drug development companies to partner with good manufacturing practices (GMP) / chemistry manufacturing and controls (CMC) contract labs to conduct analyses of a range of small molecules and biologics and drive therapies forward (..)

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

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Pharmacokinetics Drugs FDA Production 52

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The overall development strategy for GT123 was to include a complete CMC package.

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Drugs Packaging Clinical Pharmacology Small Molecule 52

PerkinElmer

JANUARY 21, 2021

Using drugs that are already on the market was the quickest path forward to evaluate these compounds and possibly help patients now because novel drug development typically takes years. Scientists needed to evaluate the field of potential drugs-and fast. It is, therefore, a tricky target for drugs.

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Treatment Small Molecule Drugs Virus 52

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. Strovel, PhD, Chief Executive Officer of Veralox Therapeutics. About VLX-1005.

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NIH Director's Blog: Drug Development

OCTOBER 30, 2018

Now comes word of another absolutely incredible use of cryo-EM: determining with great ease and exquisite precision the structure of the smaller organic chemical compounds, or “small molecules,” that play such key roles in biological exploration and drug development. Also analyzed were eight less-familiar small molecules.

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Small Molecule Science Drug Development Organic Chemistry 52

The Pharma Data

FEBRUARY 24, 2022

Researchers at the University of North Carolina at Chapel Hill and the UNC Lineberger Comprehensive Cancer Center have uncovered a new role of a chromatin-modulatory enzyme, termed EZH2, during cancer development. They then developed a new therapeutic approach with a potent small-molecule inhibitor of this enzyme.

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Small Molecule Cell Biology Research Drug Development 52

Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

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Drugs FDA Approval Organic Chemistry Small Molecule 69

Drug Target Review

NOVEMBER 1, 2023

Could you provide an overview of your research on target directed cancer drug discovery, particularly your focus on protein lagging interactions. I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre. 2013) 56, 2059-2073.

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The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. Degradants are impurities arising from the degradation of the drug substance or a reaction with an excipient and/or the immediate container.)

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Small Molecule DNA Drugs Clinical Development 52

Alta Sciences

NOVEMBER 5, 2024

Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution. Drugs can be encapsulated in the form of beads, micro tablets, and pellets, in combination with the liquid formulation.

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Drug Target Review

NOVEMBER 6, 2023

To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required. 6 In all these examples, an effective backbone drug was first developed, before adding one or more drugs to establish the new regimens.

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Drug Target Review

SEPTEMBER 26, 2024

Cresset delivers software solutions and contract research expertise enabling companies around the world to accelerate their small molecule discovery processes efficiently and effectively. What are the potential benefits associated with using AI to generate new drug candidates? Then comes resource optimisation.

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Drugs Production Research Small Molecule 64

PLOS: DNA Science

SEPTEMBER 5, 2024

Today for many patients, it is the beginning of taking a series of drugs that specifically target the errant cells by blocking the signals that fuel their runaway cell division, while sparing healthy cells. If deployed early, AI might identify drugs unlikely to work more effectively than can genetic and genomic testing.

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