2024, Disease, Pharmacokinetics and Regulations

Considering the use of animal models in drug development

Drug Discovery World

AUGUST 13, 2024

They are assumed to closely mimic human disease progression and act as a good testing ground for toxicology studies and pharmacokinetics 1. A lack of translatability The most obvious argument against the continued blanket requirement for AMs is that they are not very translational for many disease areas. Possibly not.

Drug Development

Drug Development Animal Testing Regulations Drugs

Study offers possible treatment for frontotemporal dementia

Drug Discovery World

SEPTEMBER 9, 2024

Vesper Bio has completed a Phase I study for its lead candidate, VES001, a potentially disease-modifying treatment for frontotemporal dementia patients with mutations in the progranulin gene (FTD(GRN)). Frontotemporal dementia is the most common cause of dementia in people under the age of 60.

Treatment

Treatment Pharmacokinetics Small Molecule Trials

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

DECEMBER 1, 2023

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. Now, the FDA has issued its first post-PHE version of this guidance Although the previous version of the guidance was revised to remain in effect until March 7, 2024, it has now been replaced.

FDA

FDA Clinical Trials Vaccine Trials

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science

Science FDA Clinical Trials Pharmacy

First-in-human Phase I study of KMO inhibitor launches in UK

Drug Discovery World

MAY 19, 2023

The study aims to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of KNS366 in healthy adult participants. Full results from the study are expected in early 2024. The study is being conducted at a single site in the UK.

Pharmacokinetics

Pharmacokinetics Clinical Development Clinical Trials Trials

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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

Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

FDA

FDA Science Biosimilars Production

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. The agency issued a new draft guidance on DAPs in June 2024, several months after the Congressional deadline had passed.

Science

Science FDA Production Trials

SRP-001: redefining pain treatment with a safer, non-opioid analgesic

Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. Scientific Reports 14, 11103 (2024). We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment

Treatment Clinical Trials Molecular Biology Therapies

How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. substance abuse, sexual activity), can influence the risk and likelihood of developing a disease or other long-term health issues—as well as the way an individual responds to treatment. Tags Clinical Trials Weight 15

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

FDA Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

FDA

FDA Clinical Trials Disease Trials

Analysis Life Sciences Thank You FDA solidifies its advice on dose optimization for oncology products

Agency IQ

AUGUST 16, 2024

By Rachel Coe, MSC | Aug 12, 2024 6:15 PM CDT Background For decades, sponsors have turned to maximum tolerated dose (MTD) as the primary method for dose selection in oncology. Today, though, patients, clinicians, and regulators expect more. In early-stage development of traditional cytotoxic oncology drugs (i.e., What’s new?

Production

Production FDA Science Clinical Trials

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

BY KIRSTEN MESSMER, PHD, RAC, KARI OAKES | JAN 31, 2024 9:01 PM CST Regulatory Background Cancer is the second leading cause of death in the E.U. after ischemic heart disease and stroke. In 2019 more than one in four (28%) of deaths in the E.U. were from cancer. Even under the shadow of the Covid-19 pandemic, 1.2

Clinical Trials

Clinical Trials Trials Treatment Production

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES | FEB 21, 2024 7:48 PM CST Background: Dose-finding in oncology Traditionally, early development of oncology products has focused on identifying the maximum tolerated dose (MTD) of an investigational product.

Science

Science FDA Trials Clinical Pharmacology

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

Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. As more data have been collected on products previously approved, regulators have started to look back at them with a more critical gaze.

FDA

FDA Science Clinical Trials Trials

Article EMA Thank You Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD | FEB 22, 2024 11:57 AM CST Background: The prevalence of obesity, and its complications, in Europe Obesity is generally defined using a crude metric referred to as body mass index (BMI). Key Documents and Dates Reflection paper on investigation of pharmacokinetics in the obese population

Drugs

Drugs Clinical Trials Pharmacokinetics Drug Development

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. § Basis at 18; NPRM at 44,605.

Regulations

Regulations FDA Licensing Licensing

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

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. at a Friends of Cancer Research event in February 2024. ANNA ESHOO (D-Calif.)

FDA

FDA Science Clinical Trials Production

Drug Discovery Digest

Considering the use of animal models in drug development

Study offers possible treatment for frontotemporal dementia

Trending Sources

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

First-in-human Phase I study of KMO inhibitor launches in UK

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

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

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

SRP-001: redefining pain treatment with a safer, non-opioid analgesic

How Improving Diversity Can Benefit Clinical Trials

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

Analysis Life Sciences Thank You FDA solidifies its advice on dose optimization for oncology products

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

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

Article EMA Thank You Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

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