Drug Target Review

DECEMBER 11, 2024

This approach not only boosts our clients’ ability to achieve high accuracy and meet regulatory requirements but also supports the seamless transition of innovative therapies from the lab to the clinic with confidence. Once the IS has been selected, a quantitation range can be set using reference solutions.

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Drug Target Review

JUNE 19, 2025

Bazan sees it as part of a broader shift towards combination therapies – an approach that will likely define the next generation of pain management. South Rampart Pharma has completed its Phase 1 clinical trial, demonstrating strong safety, tolerability and pharmacokinetics. From bench to bedside: what is next?

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Clinical Trials Molecular Biology Treatment Trials 52

New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [4] It is taken by mouth. [1] 14 : 17588359221113694.

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The Pharma Data

JULY 2, 2025

Detailed data from the trial will be shared at an upcoming medical conference. The primary objective of the trial was to evaluate the safety and tolerability of ARGX-119. Importantly, nearly all participants in the Phase 1b trial had previously enrolled in an observational natural history study initiated by argenx in 2024.

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Alta Sciences

FEBRUARY 19, 2025

The guidance ensures that these targeted evaluations help identify and mitigate safety concerns early in the development process, supporting the safe progression of oligonucleotide therapies into clinical trials.

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Drug Development Clinical Pharmacology Immune Response Drugs 52

Broad Institute

OCTOBER 29, 2024

Importantly, unlike other MCL1 inhibitors that have raised concerns about cardiovascular side effects in early-stage clinical trials, BRD-810 acts quickly within cancer cells and is eliminated from the body in animal models within a few hours. This rapid clearance minimizes the drug’s potential impact on healthy cells.

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The Pharma Data

JUNE 25, 2025

These studies demonstrated that the BRUKINSA tablet formulation is bioequivalent to the existing capsule form, confirming that patients switching between formulations can expect comparable pharmacokinetics and clinical outcomes. In the United States, BRUKINSA has continued to demonstrate its clinical and commercial strength. Source link

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Packaging Pharmacokinetics Therapies Marketing 52

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. While some therapeutic areas still rely heavily on NHPs – like biologics and gene therapies – many others are exploring models that offer better scalability and ethical acceptability.

Drug Research 52

Drug Research Research Animal Testing Drugs 52

Alta Sciences

DECEMBER 31, 2024

The issue also features a drug-drug interaction case study, in which the effects of two doses of a sponsors investigational product on the pharmacokinetics of multiple oral doses of clopidogrel, and a single dose of warfarin in healthy adult subjects were evaluated. The Altascientist, Issue 7, pg.

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DrugBank

JUNE 18, 2025

Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Drug development is a complex and highly regulated process.

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The Pharma Data

JUNE 18, 2025

The therapy is administered via subcutaneous injection and is being studied for its ability to produce and sustain significant weight loss over extended periods. The findings are expected to inform healthcare systems and providers about adherence gaps and optimization strategies in statin and non-statin therapy use. to 3:00 p.m.

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Drug Target Review

MARCH 17, 2025

However, a deeper understanding of brain function particularly the role of synaptic plasticity is now opening the door to innovative therapies. The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked.

Treatment 52

Treatment Licensing Licensing Science 52

DrugBank

JULY 14, 2025

Drug-drug interactions (DDI) are a significant concern in clinical trials, where the safe and effective administration of drugs to patients is crucial. The pharmacokinetic and pharmacodynamic properties of each drug and the patient’s individual variability contribute to the potential for interactions.

Clinical Development 52

Clinical Development Pharmacokinetics Drugs Clinical Trials 52

New Drug Approvals

JUNE 25, 2025

While this therapy can decrease blood glucose level, it has limited efficacy and tolerability, causes weight gain and often induces hypoglycemia. (B) clinical candidate currently in Phase 2 development. glipizide, glimepiride, glyburide) and meglitinides (e.g., B) Biguanides (e.g., Aggarwal, N.; Denney, W.S.; Calle, R.A.

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Small Molecule Treatment Regulations Drugs 62

New Drug Approvals

APRIL 18, 2025

2] History Crinecerfont’s approval is based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic congenital adrenal hyperplasia. [2] 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] 1 December 2024.

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FDA FDA Approval Drugs Trials 62

New Drug Approvals

APRIL 19, 2025

elimination half-life (min) cardio-selectivity (1/2) metabilization Landiolol 4 250 pseudocholinesterases Esmolol 9 30 ery-esterases Metoprolol 420 3 cytochrom P2D6 (Leber) History The beneficial effects of landiolol have been demonstrated in over sixty clinical trials (pubmed search -August 2018). New Drug Therapy Approvals 2024 (PDF).

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PPD

APRIL 14, 2025

This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. The SELECT trial set out to understand whether the drug has similar effect on patients without diabetes.

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Clinical Trials Trials Clinical Development Disease 52

The Pharma Data

JUNE 18, 2025

Biogen Launches Global Phase 3 Pediatric Trial of Omaveloxolone for Friedreich Ataxia Biogen has officially launched its BRAVE study a pivotal, global Phase 3 clinical trial aimed at evaluating omaveloxolone in pediatric patients with Friedreich ataxia (FA). Head of the Neuromuscular Development Unit at Biogen.

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Trials Clinical Trials Treatment Disease 40

New Drug Approvals

JULY 18, 2025

9] Azvudine is under investigation in clinical trial NCT04668235 (Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (Sars-cov-2 Infected)). 14] Curiously, no full results of the trial have been made available for this study in any journal detailing the experiment design as of December 2022. [23]

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RNA Clinical Trials Virus Trials 62

DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. cell and gene therapies), with other therapeutic areas then pushing it further. Barriers to Enrollment Recent findings indicate significant barriers to enrolling patients remain in clinical trials.

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DrugBank

MARCH 7, 2024

Moreover, Novo Nordisk and Eli Lilly are expected to unveil new clinical trial data that could highlight additional health benefits of their drugs beyond weight loss and diabetes management, potentially paving the way for broader insurance coverage. While challenges persist, the weight loss drug boom shows no signs of waning.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.

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Clinical Trials Trials Pharmacokinetics FDA 83

The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. Multiple ascending dose and food effect study results.

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Drug Target Review

SEPTEMBER 25, 2024

Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades. The reactivation of oncogenic signalling upstream or downstream of the driving oncogene is a well-studied source of resistance to targeted cancer therapies.

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Small Molecule Therapies Regulations Treatment 105

Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., Human and mouse genetics can inform not only efficacy but also safety. in liver, in CNS)?

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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. Tags Clinical Trials Weight 1

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Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

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Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. Read it now. The Altascientist : Issue No. The Altascientist : Issue No. Read or listen now. Watch the video. Read the fact sheet. Read or listen now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

The Pharma Data

DECEMBER 27, 2020

Phase I Trial. phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. This trial also investigates the food effect on ASC42 exposure.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. James Miessler. Source link.

Disease 52

Disease Small Molecule Pharmacokinetics Licensing 52

Drug Target Review

OCTOBER 24, 2023

We identified these species as being important for treatment of UC by generating and analysing metagenomics data from a Faecal Microbiota Transplant (FMT) trial that was undertaken at the University of Adelaide. In addition to analysing metagenomics data, we also isolated bacteria from the healthy donor stool banked as part of that trial.

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Treatment Pharmaceuticals Pharmacokinetics Trials 122

The Pharma Data

AUGUST 30, 2021

A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. Yancopoulos, M.D., President and Chief Scientific Officer at Regeneron. “ In 2016, the U.S.

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Trials Disease Treatment Clinical Trials 52

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We

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