Clinical Pharmacology, International and Therapies

The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. There are several types of biomarkers to consider.

Clinical Development

Clinical Development Clinical Trials Clinical Pharmacology Trials

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

1] Society and culture Names Eplontersen is the international nonproprietary name. [9] “Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. 12 (1): 267–287. doi : 10.1007/s40120-022-00414-z.

Clinical Trials

Clinical Trials FDA Clinical Pharmacology FDA Approval

XPhyto Secures Exclusive Psychedelic Drug Development Agreement

The Pharma Data

NOVEMBER 9, 2020

He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse. Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S.

Drug Development

Drug Development Drugs Clinical Pharmacology Pharmaceuticals

Landiolol

New Drug Approvals

APRIL 19, 2025

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. New Drug Therapy Approvals 2024 (PDF). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al.

FDA

FDA Clinical Trials Treatment Trials

ATICAPRANT

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

Treatment

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

Science

Science Biosimilars FDA Production

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

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. AgencyIQ has identified several major themes in the FDA’s oncology work.

FDA

FDA Science Clinical Trials Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

AgencyIQ has analyzed the agency’s guidance agendas, user fee commitment letters, statutory obligations and international efforts to determine which guidance documents the agency is actively working on this year (and in some cases, in the years ahead as well).

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA

FDA Science Regulations Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes Request for Information February 29 (Extended) Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments Draft Guidance March 11 Advanced Manufacturing Technologies Designation Program Draft Guidance March (..)

FDA

FDA Science Clinical Trials Regulations

FDA’s Project Optimus: A new era in oncology drug dosing

Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. Molecular factors Molecular markers, such as protein expression and signalling pathway activation, also guide therapy choices.

Clinical Trials

Clinical Trials Trials Drugs Drug Development

Acoramidis

New Drug Approvals

APRIL 21, 2025

The DMSO solution of the alkyl bromide were slowly transferred in order to maintaining an internal temperature of 55.05 Methanol is then removed by vacuum distillation at an internal temperature of NMT 35 C. 20] Acoramidis is the international nonproprietary name. [21] New Drug Therapy Approvals 2024 (PDF). January 2025.

FDA Approval

FDA Approval FDA Production Treatment

Drug Discovery Digest

The rising impact of biomarkers in early clinical development

Eplontersen

Trending Sources

XPhyto Secures Exclusive Psychedelic Drug Development Agreement

Landiolol

ATICAPRANT

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

FDA’s Project Optimus: A new era in oncology drug dosing

Acoramidis

Stay Connected