Drug Target Review

SEPTEMBER 25, 2024

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. This orally available small molecule binds to the bromodomain of CBP/p300 in a highly specific manner.

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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. billion USD in 2023 to $166.53 billion USD by 2028.

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Drug Target Review

APRIL 7, 2025

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions. References Sun D, et al. doi:10.1016/j.apsb.2022.02.002.

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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. link] Accessed October 2023. Accessed October 2023.

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Conversations in Drug Development Trends

APRIL 4, 2024

Since reaching full implementation on January 21, 2023, numerous regulatory bodies have adopted the ICH M10 standards. Stability Tests: For small molecule, only -20°C stability testing is required, while large molecule need both -20°C and -70°C tests if samples are intended for storage at these temperatures.

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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. Asia, and Europe.

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Drug Development Treatment Drugs FDA Approval 52

The Premier Consulting Blog

NOVEMBER 20, 2024

For drugs with FDA Orphan Drug Designation (ODD), Breakthrough Therapy Designation (BTD), and EMA PRIority MEdicines designation (PRIME), all clinical, non-clinical, and CMC requirements are still required for regulatory approval, despite being on pathways for an expedited approval process.

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PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

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Laboratories Assay Development Small Molecule Drug Development 52

Alta Sciences

JUNE 2, 2023

Expert Support for Your IND/CTA Requirements rmaloney Fri, 06/02/2023 - 17:33 HTML Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible.

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The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. It can simply start with a strategic assessment of your drug product. [i] FDA-2023-N-2850.

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PPD

JUNE 27, 2024

In recent years, AA has followed in the footsteps of other dermatology indications — including psoriasis and atopic dermatitis — with growing research and clinical studies focusing on small molecules with broad cellular effects (JAK and PDE4 inhibitors) and cytokine-specific molecules antagonists (IL-23, Th2 and IL17) to treat the condition.

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New Drug Approvals

APRIL 2, 2025

1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management. August 2023).

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Sygnature Discovery

OCTOBER 10, 2023

On 10th October 2023, Sygnature Discovery, a world-leading integrated drug discovery provider and non-clinical solutions provider, has announced a scientific collaboration with human induced pluripotent stem cell (iPSC) experts, Axol Bioscience.

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Drug Target Review

JULY 12, 2023

If there is robust gene expression data for the aspect of a disease that we are aiming to reduce or eliminate, the DCT mechanism will find results that can lead us to promising new drug candidates. We are pleased that to date our lead product candidate has aligned DCI profiles as expected.

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Elrig

APRIL 29, 2024

Fascinated by the potential of AI in medical research, I transitioned to BenevolentAI in early 2023 as a Biology Project Leader. There, I supported AI-enabled DD efforts in their small molecule portfolio.

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Bioinformatics Drugs Molecular Biology Cell Based Assays 59

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Drug Discovery. nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

APRIL 19, 2024

As the FDA’s Center for Drug Evaluation and Research (CDER) characterized it in a 2023 call for comments : “Evolving understanding of disease biology and molecular pharmacology, advancements in drug discovery, and growth in novel therapeutic platforms (i.e., many overlap with the goals of this latest initiative.

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Clinical Trials Trials Science FDA 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. Improved Return on Investment (ROI) Industry-academic partnerships can enhance the financial return on drug development investments.

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Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs.

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The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024.

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Small Molecule Clinical Development Disease Science 52

Agency IQ

APRIL 19, 2024

The most recent accelerated approvals occurred in August 2023: Elrexfio (elranatamab-bcmm; Pfizer) and Talvey (talquetamab-tgvs; Janssen). These drugs were both approved for relapsed or refractory (RR) MM patients who had already received at least four prior lines of therapy.

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Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Initial approval in 2023: FDA, U.S. Then 1 packet to be used twice daily thereafter.

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Treatment Clinical Trials Small Molecule Therapies 81

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Dive Brief: Shares of San Diego biotechnology company Cidara Therapeutics doubled Monday after the company revealed positive mid-stage study results for an experimental preventive therapy it’s developing for seasonal influenza. Influenza A virus" [Micrograph]. Retrieved from Flickr.

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Vial

DECEMBER 11, 2023

Hepatitis C Virus (HCV) Drug Development There is an urgent need to develop novel, efficient, reliable, and cost-effective diagnostic technologies and therapeutic and immune prophylactic interventions to manage HCV. The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs.

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Drug Target Review

JANUARY 16, 2025

What are macrocycles and why are they interesting for drug discovery? Traditionally, drug discovery has focused on small-molecule therapeutics, typically with a molecular weight of less than 500 Daltons. 2 Typically, small-molecule drugs target active sites buried inside proteins.

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Drug Development Small Molecule Drugs FDA Approval 52

Drug Target Review

APRIL 11, 2025

Drug development is hampered by high costs, long timelines and a low probability of success and complex therapies exacerbate these challenges. Even excluding repositioned drugs, which could benefit from pre-existing toxicology and clinical data, a significant increase in PoS is still observed. This is an AI-generated image.

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Clinical Development Drugs Pharmaceuticals Clinical Trials 97

Drug Target Review

APRIL 25, 2025

2 Liver CIVMs offer several benefits over conventional in vitro systems including prolonged functional activity, enhanced expression of various drug-metabolising enzymes and transporters, and improved cell-cell and cell-ECM (extracellular matrix) interactions. Trends Biotechnol 41 (2023) 278280. Organs-on-chips: a decade of innovation.

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Clinical Development Small Molecule Drugs FDA Approval 52

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

Drug Target Review

DECEMBER 11, 2024

Frontiers in Medicine 2023 May 12;10. 2023 Apr 13;20(6):35971. Nature Reviews Drug Discovery. 2023 Oct 27;22(12):9961017. 2023 Feb 15;9(7). 2023 Jul 24;186(16):3333-3349.e27. 2023 41:10991106 Etcembly Long Term Survivor study. Johnson DB, Nebhan CA, Moslehi JJ, Balko JM. 2022 Jan 26;19(4):25467.

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Drug Target Review

FEBRUARY 15, 2024

11 Health agencies globally must collaborate with academic research centres and industry to address this important gap in drug treatments for pandemic-prone pathogens. Research teams must be able to rapidly identify small molecules that target biochemical pathways that are conserved across multiple viruses within a family.

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Codon

MAY 29, 2025

While small-molecule drugs continue to play a critical role in modern medicine, we are witnessing a shift toward the increasing development of amino acid-based therapeutics. Peptide-Based Drugs Sessile organisms, whether a sponge, coral, plant, or mushroom, are often quite literally between a rock and a hard place.

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