2025, Pharmacokinetics and Regulations

Therapeutic Oligos 2025 Keynote Speakers Announced

Elrig

MARCH 25, 2025

After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona). Back to Resources Find out more The post Therapeutic Oligos 2025 Keynote Speakers Announced appeared first on ELRIG.

RNA

RNA Bioinformatics Science Pharmacokinetics

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

Drug Development

Drug Development Clinical Pharmacology Immune Response Drugs

Time for change: non-human primates in drug research

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. 3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming. Are we nearing a post-NHP future?

Drug Research

Drug Research Research Animal Testing Drugs

BeOne Medicines Gains CHMP Backing for BRUKINSA Tablet Formulation

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.

Packaging

Packaging Pharmacokinetics Marketing Therapies

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. Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies?

Treatment

Treatment Clinical Trials Therapies Molecular Biology

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

FDA

FDA Trials Therapies Regulations

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

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. What about combination products?

Science

Science FDA Production Drugs

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” Industry wants its products reviewed quickly, efficiently and predictably. Without sufficient resources, the FDA is unable to do so. Read the full AgencyIQ analysis here.

FDA

FDA Pharmacokinetics Clinical Pharmacology Government

How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Discover how drug developers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Drug Development

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. This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition.

FDA

FDA Clinical Trials Disease Trials

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

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA

FDA Science Biosimilars Clinical Trials

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

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. ANNA ESHOO (D-Calif.)

FDA

FDA Science Clinical Trials Production

Omaveloxolone

New Drug Approvals

MAY 11, 2025

10] Nrf2 transcriptionally regulates multiple genes that play both direct and indirect roles in producing antioxidative potential and the production of cellular energy ( i.e. , adenosine triphosphate or ATP ) within the mitochondria. Retrieved 17 April 2025. 2] [5] It is taken by mouth. [2] 9] SYNTHESIS PATENT Sheikh, AY et al.

FDA

FDA FDA Approval Disease Production

LB-102: Redefining schizophrenia treatment in drug discovery

Drug Target Review

APRIL 21, 2025

These medications primarily work by blocking dopamine receptors in the brain, specifically the D2 receptors, which are involved in regulating mood and behaviour. The road ahead The next step for LB-102 is the initiation of pivotal Phase III trials, expected to launch in late 2025.

Treatment

Treatment Drugs Trials Clinical Trials

Drug Discovery Digest

Therapeutic Oligos 2025 Keynote Speakers Announced

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Trending Sources

Time for change: non-human primates in drug research

BeOne Medicines Gains CHMP Backing for BRUKINSA Tablet Formulation

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

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

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

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

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 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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

Omaveloxolone

LB-102: Redefining schizophrenia treatment in drug discovery

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