Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

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Clinical Research Drug Development Treatment Research 111

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Starting with the right internal standard Selecting the appropriate internal standard (IS) is vital in toxicology, as inaccuracies could obscure toxic metabolites and lead to flawed safety evaluations.

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International Laboratories Drugs Pharmacokinetics 52

Drug Target Review

DECEMBER 6, 2024

In cases where control or treatment groups show large variability, this could reflect true biological responses to a treatment, and removing such data could reduce the accuracy of the analysis. It is crucial during this phase to strike a balance between removing erroneous data and preserving meaningful biological variability.

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RNA Drugs Research Science 52

Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company. Financing and recruitment of the best people has been more challenging work than I had expected.

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Pharma Companies Licensing Licensing Disease 111

PLOS: DNA Science

SEPTEMBER 5, 2024

Targeted cancer drugs developed to treat one type of cancer often expand, with further testing, to treat other types, based on molecular similarities. Diagnosis began to shift from a body-part basis to a molecular one, which I wrote about in “Mutation and location important in cancer treatment” for The Lancet in 2015.

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Treatment FDA Approval DNA Small Molecule 71

Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. million people every year.

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Vaccine Trials Therapies Clinical Trials 92

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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Clinical Trials Treatment Trials Drug Development 52

PPD

JUNE 7, 2023

As therapies for the treatment of NASH in adult patients go this year to the U.S. Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. We are poised to use our expertise to advance your treatment.

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Trials Clinical Trials Clinical Research Disease 98

Drug Target Review

NOVEMBER 6, 2023

Advances in research and development and the utilisation of combination treatment strategies are revolutionising the haematology care landscape, but more must be done to address patients’ individual needs. This article was written and developed by AstraZeneca. References Blood Cancer UK. link] Accessed October 2023.

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Small Molecule Therapies Treatment Disease 111

NIH Director's Blog: Drug Development

OCTOBER 27, 2020

Another promising strategy is drugs that target the proteins within human cells that the virus needs to infect, multiply, and spread. They found that COVID-19 patients taking indomethacin were less likely than those taking an anti-inflammatory that doesn’t target PGES-2 to require treatment at a hospital.

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Drug Development Drugs Virus Science 52

Drug Target Review

JULY 7, 2023

In pregnant individuals, maternal autoantibodies can even attack the organs and tissues of the foetus, 1-9 Many of these diseases are rare, with no safe, targeted, advanced and effective treatment options approved for patients in need. 16,17 There are currently no approved therapeutics for the treatment of HDFN.

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. Food and Drug Administration authorized and approved the new shot.

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Trials Clinical Trials International Regulations 59

Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. One such approach is standardizing imaging protocols across your trial sites — consistency is key.

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Trials Clinical Trials Compliance Treatment 81

Drug Target Review

AUGUST 9, 2024

For other compounds, it can be beneficial to target the drug more precisely to the affected area. Inhalers are useful in respiratory conditions, whereas topical treatments can be applied directly to the skin for localised treatment. Developing the correct formulation for these treatments will be key to ensure they are effective.

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Science Drugs Compliance Drug Development 59

Drug Target Review

MAY 27, 2024

Caris Discovery, the therapeutic research arm of Caris Life Sciences, was launched to address the paucity of novel oncology drug targets and is uniquely poised to discover first-in-class ADC targets. What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans?

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Clinical Trials Science Molecular Biology Bioinformatics 59

Metabolite Tales Blog

NOVEMBER 17, 2022

Due to internal hydrogen bonding, DELAQ is a linear, nonionized metabolite with a LogP of roughly 7. Figure 2: Internal hydrogen bonding of DELAQ In contrast to laquinimod, DELAQ is a very potent activator of the aryl hydrocarbon receptor (AhR). and a topological polar surface area (TPSA) of 61 Å 2.

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International Licensing Licensing Treatment 52

Conversations in Drug Development Trends

AUGUST 9, 2024

It broadens recruitment strategies, diversifies the patient population, and expands the study population, thus increasing access to potentially life-saving treatments. These trials increase the chances of success by enabling the early detection of effective treatments in defined populations and focusing efforts on the most promising options.

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Trials Clinical Trials Regulations FDA 80

The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. About LogicBio Therapeutics.

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The Pharma Data

APRIL 6, 2022

Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus – Innovative Medicines US and Innovative Medicines International. Change in Global Drug Development (GDD) Leadership. Novartis has appointed Shreeram Aradhye, M.D.,

International 52

International Pharmaceuticals Drug Development Marketing 52

Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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Therapies Virus DNA Clinical Trials 124

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? It has a well-defined and strategically focused R&D pipeline of innovative treatments targeting various stages of Parkinson’s as they worsen over time. The fifth project is a potential new basic and first-line treatment that could replace levodopa.

Disease 52

Disease Drugs Treatment Drug Development 52

DrugBank

NOVEMBER 4, 2024

   Urgency of Antibiotic Resistance    The escalating threat of antibiotic resistance is an incoming global crisis projected to affect international health and the economy. While the demand for novel antibiotics is undeniable, the industry still struggles with the harsh realities of antibiotic drug development.

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Pharmaceutical Companies Pharmaceuticals Government DNA 71

The Pharma Data

JANUARY 19, 2021

or (973) 890-8355 (International), conference ID 1580376. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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FDA Approval Laboratories Disease Pharmaceuticals 52

The Pharma Data

NOVEMBER 30, 2020

or (973) 890-8355 (International), conference ID 7442859. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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FDA Approval Laboratories Disease Pharmaceuticals 52

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1].

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Drugs Disease Drug Development Clinical Trials 52

PPD

JUNE 20, 2024

To accelerate clinical research timelines, pharmaceutical developers need to tap into solutions that demonstrably streamline drug development from start to finish. Our comprehensive suite of services covers every aspect of drug development, empowering our clients to navigate the complexities of clinical research with confidence.

Clinical Research 52

Clinical Research Research Clinical Trials Pharmaceuticals 52

Drug Target Review

JULY 6, 2023

Ex vivo substitutes to animal testing Scientists are developing ex vivo assays, which involve performing experiments on living tissues in a cultured environment outside of an organism while maintaining natural conditions. A new research paper, co-authored by PETA Science Consortium International e.V., Annals of Internal Medicine.

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Animal Testing Drugs Clinical Trials Clinical Research 105

The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. International Agency for Research on Cancer. To schedule a conversation with one of our experts, click here.

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FDA Clinical Trials Therapies Trials 52

Drug Target Review

OCTOBER 14, 2024

Wilkie’s background as a biochemist and his time at Merck, a leading pharmaceutical company, shaped his early understanding of drug development and business strategy. As someone who describes himself as an “enthusiastic sceptic,” Wilkie is cautious but hopeful about the potential of AI in drug development. “I

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Science Pharmaceutical Companies Drug Development Pharmaceuticals 52

The Pharma Data

NOVEMBER 10, 2020

By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations. Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. SAN FRANCISCO and SUZHOU, China , Nov.

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Biosimilars Clinical Trials International Clinical Development 52

DrugBaron

OCTOBER 17, 2022

Not long enough treatment? Of course, Occam’s razor suggests the simplest explanation is likely to be right: the drug just doesn’t work well enough – but many millions are often burnt before the inevitable conclusion is reached. Maybe it was the wrong patient population? The wrong dose? The wrong end-point? But how to proceed?

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Pharma Companies Pharmaceuticals Drug Development Production 100

Drug Target Review

OCTOBER 31, 2023

Given there were no other drugs available to them, I cannot even describe the urgency I felt when I entered the project on the drug development side. The drug ended up getting approved, and it extended the lives of children many years where they previously would have had four months at best.

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Cell Biology Pharmaceuticals Science Disease 107

Agency IQ

OCTOBER 20, 2023

FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.

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FDA Treatment Trials Therapies 40

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

The Pharma Data

NOVEMBER 10, 2020

The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments. . . SAN FRANCISCO , U.S. and SUZHOU, China , Nov. ” About Letaplimab.

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Clinical Trials Treatment Trials Disease 52

The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. This is the third approval in China for tislelizumab, and its first in a lung cancer indication.

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Production Trials Clinical Trials Treatment 52

The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Dynacure , a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today the appointment of Jean M. and international companies. Franchi to its Board of Directors.

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