Drug Target Review

MARCH 17, 2025

The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. Hopes for the Phase IIb trial Donello discusses the key outcomes he hopes to see in the Phase IIb VITALIZE study of zelquistinel for major depressive disorder (MDD).

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Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes.

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Agency IQ

DECEMBER 1, 2023

Furthermore, the guidance offered a list of updated clinical outcome measures and offered insight on FDA’s evolving view of decentralized clinical trials and the use of real-world data to supplement trials. Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

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Agency IQ

FEBRUARY 2, 2024

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. This enables patient selection, stratification and other adjustment in clinical trial design planning. after ischemic heart disease and stroke.

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Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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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FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot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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Agency IQ

AUGUST 11, 2023

In AgencyIQ’s thinking, the contract notice could also indicate that the FDA is working to build out its capabilities related to its new authority to conduct RRAs of facilities involved in clinical trials. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

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Alta Sciences

APRIL 17, 2024

In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings. According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. Asia, and Europe.

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Metabolite Tales Blog

APRIL 10, 2024

Several conjugates circulate in humans; the main circulating metabolites reported from one trial (oral 400mg/day dose over 14 days) include a glutathione-related metabolite (M1), a cysteine conjugate (M2) and an N -acetylcysteine conjugate (M3). Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development.

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Agency IQ

DECEMBER 11, 2023

This guidance joined others in the FDA’s catalog that focus on diversity in research, including its 2022 guidance on inclusion of older adults in cancer clinical trials and its November 2020 guidance on “ Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.”

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The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. Forward-Looking Statements.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066).

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Molecular Design

FEBRUARY 7, 2023

However, the CYP51 inhibitor posaconazole (an antifungal medication) showed poor efficacy in a clinical trials for chronic Chagas disease. Does this mean that CYP51 is a bad target? The quick answer is “maybe but maybe not” because we can’t really tell whether the lack of efficacy is due to irrelevance of the target or inadequate exposure.

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PerkinElmer

JUNE 3, 2022

2 PF-07321332, which is now being tested in clinical trials, 3 is a nitrile-containing derivative of PF-00835231. In this article, we highlighted two recently published studies focused on the discovery of inhibitors of SARS-CoV-2 M pro , including one now being tested in clinical trials.

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The Anticancer Fund

JUNE 7, 2022

Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context. This is another study that is strongly supportive of replication and further development, including clinical trial development.

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The Anticancer Fund

APRIL 1, 2022

Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context. A small phase I clinical trial (NCT04942626) is testing this hypothesis in rectal cancer patients.

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PPD

JUNE 20, 2023

Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article. We have you covered in our comprehensive overview of outsourced clinical trial models. And for sponsors, this strategy reduces overhead, in turn offering business continuity, flexibility and potential cost savings.

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The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. These issues are especially apparent in treatments that are intended for chronic use.

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Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. ” Clinical trials are underway. Read “Musk's brain implant company in search of human trials partner.” Thanks for skimming. ❤️ Subscribe to support human writers.

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Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. Once metabolized, which occurs quickly with a half-life of approximately 1.5

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The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease. About the COMET-ICE Study Design.

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Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

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Agency IQ

SEPTEMBER 22, 2023

Traditionally, FDA has interpreted the need for “well-controlled investigations” to mean at least two clinical trials for new drugs, or applications for supplemental indications. When looking at all drugs approved between 2011 and May 2020, 136 drugs were approved on the basis of a single pivotal trial, according to AgencyIQ’s research.

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The Pharma Data

MARCH 5, 2021

The CHMP scientific opinion under Article 5.3 ” To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Across all treatment arms, the trial will enroll up to 3,300 participants.

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Agency IQ

JUNE 9, 2023

However, nonclinical studies are not conducted exclusively before human trials begin; they usually continue throughout the early phases of clinical trials to further assess a product’s performance on different metabolic pathways and at different doses.

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Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

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Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. However, the “extent” of the data (comparability, CAA) will depend on the risk assessment of differences – and, in “some cases,” additional data like pharmacokinetic studies might be needed.

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Agency IQ

AUGUST 16, 2024

chemotherapies), sponsors have historically pushed the envelope to find the highest tolerable dose when conducting clinical trials for oncology products, since higher doses generally mean increased efficacy for these products. In early-stage development of traditional cytotoxic oncology drugs (i.e.,

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Agency IQ

FEBRUARY 23, 2024

That passage is referred to as pharmacokinetics (PK) and incorporates four important phases – absorption, distribution, metabolism, and excretion (ADME). Similarly, the EMA has not historically offered guidance on the inclusion of patients with obesity in clinical trials, or the targeted evaluation of drug disposition in these patients.

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Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Chemical Biology and Drug Design

JANUARY 25, 2025

Compounds 4 , 5 , 9 11 displayed a remarkable EGFR-TK invitro inhibitory activity, induced apoptosis in NCI-H522 cell line, and showed predicted ADME pharmacokinetic profile. They showed a remarkable invitro EGFR inhibitory activity that was comparable to erlotinib, and a predicted ADME pharmacokinetic profile.

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Drug Target Review

JANUARY 20, 2025

These advances are reshaping how pharmaceutical and biotechnology companies approach clinical trial design, with a focus on patient-centric dosing strategies. This article explores how innovations in precision medicine are reshaping clinical trials, followed by a discussion on Project Optimus and its impact on dose optimisation.

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New Drug Approvals

APRIL 5, 2025

14/L Trial II (NCT00822393), a randomized active-controlled trial comparing treosulfan to busulfan with fludarabine as a preparative regimen for allogeneic transplantation. This article incorporates text from this source, which is in the public domain. ^ “Novel Drug Approvals for 2025” U.S. 57 (10): 12551265.

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. However, in order to be eligible for extended coverage under a clinical trial, several requirements must be met. Clinical trial agreement. However, this may continue to be of use to identify all costs associated with the clinical trial.

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Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. That said, FDA has not done nothing in 2024 related to clinical trial diversity.

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