2025, Pharmacokinetics and Therapies

Therapeutic Oligos 2025 Keynote Speakers Announced

Elrig

MARCH 25, 2025

Earlier in her career, she held several leadership roles within AstraZeneca, including Senior Director for Drug Metabolism & Pharmacokinetics and Director for Lead Optimisation & Enabling Technologies within medicinal chemistry.

RNA

RNA Bioinformatics Science Pharmacokinetics

Novo Nordisk: Phase 3 Data Shows Mim8 Well-Tolerated After Switch from Emicizumab in Hemophilia A

The Pharma Data

JUNE 22, 2025

The study marks a significant step forward in the treatment landscape for haemophilia A, demonstrating not only clinical safety and pharmacokinetic stability, but also strong patient preference for the Mim8 pen-injector delivery system. Throughout the 26-week study period, the investigational therapy was well-tolerated.

Pharmacokinetics

Pharmacokinetics Therapies Treatment Trials

A spatial approach to understanding drug dynamics using mass spectrometry imaging

Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. Drug Discovery Today 2025, 30 (1), 104275. Mass Spectrometry Imaging for Spatially Resolved Multi-Omics Molecular Mapping.

Drugs

Drugs Organic Chemistry Laboratories Pharmaceuticals

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

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. In the United States, BRUKINSA has continued to demonstrate its clinical and commercial strength. Source link

Packaging

Packaging Pharmacokinetics Therapies Marketing

Amgen Unveils Phase 2 Obesity Trial Results for Monthly Maritide at ADA’s 85th Scientific Sessions

The Pharma Data

JUNE 23, 2025

These pivotal findings were unveiled at the 85th Scientific Sessions of the American Diabetes Association (ADA) and were concurrently published in The New England Journal of Medicine , underscoring the significant promise of MariTide in the growing field of anti-obesity therapies.

Trials

Trials Treatment Pharmacokinetics Clinical Trials

FDA Approves Tablet Form of BeOne’s BRUKINSA® for All Indications

The Pharma Data

JUNE 11, 2025

Notably, BRUKINSA has emerged as the market leader in new CLL patient starts across all lines of therapy in the U.S. Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form. for the first time.

FDA Approval

FDA Approval FDA Treatment Therapies

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. 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

Drug Research Research Animal Testing Drugs

Amgen to Present Phase 2 Maritide Data at ADA 85th Scientific Sessions

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. At ADA 2025, the company aims to deepen the clinical narrative by sharing more comprehensive and peer-reviewed data. to 3:00 p.m.

Therapies

Therapies Clinical Trials Disease Trials

Crinecerfont

New Drug Approvals

APRIL 18, 2025

2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] Retrieved 25 January 2025. New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025. 1 October 2024.

FDA

FDA FDA Approval Drugs Trials

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study

Alta Sciences

APRIL 24, 2025

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study pmjackson Thu, 04/24/2025 - 21:43 For emerging therapies with pronounced pharmacological effects, thoughtful study design is critical to ensuring reliable and interpretable data. This blog was originally published in April 2025.

Small Molecule

Small Molecule Pharmacokinetics Treatment Compliance

Salt Lake City

Alta Sciences

JUNE 26, 2025

Pharmacokinetics

Pharmacokinetics Testimonials Biosimilars Drug Development

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). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. 32 (2): 828.

FDA

FDA Clinical Trials Treatment Trials

Gretchen Green

Alta Sciences

JUNE 26, 2025

Pharmacokinetics

Pharmacokinetics Testimonials Biosimilars Drug Development

Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution

Alta Sciences

JULY 3, 2025

Marketing

Marketing Pharmacokinetics Testimonials Biosimilars

Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

Laboratories

Laboratories Clinical Trials Protein Expression Pharmacokinetics

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

Drug Target Review

JULY 1, 2024

Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies? The global pain management market is projected to reach about $87 billion by 2025, driven by rising chronic diseases, an ageing population and more surgical procedures. SRP-001 offers a novel, non-opioid solution.

Treatment

Treatment Clinical Trials Therapies Molecular Biology

ATICAPRANT

New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20]

Treatment

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals

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

Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

FDA

FDA Trials Therapies Regulations

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. ?.

Clinical Trials

Clinical Trials Clinical Development Small Molecule Trials

Best Practices for Preclinical Dose Range Finding Studies

Alta Sciences

APRIL 11, 2025

Best Practices for Preclinical Dose Range Finding Studies pmjackson Fri, 04/11/2025 - 20:05 Dose range finding (DRF) studies are the foundation of preclinical drug development, providing crucial information on safety data to assist in the dose level selection before advancing into toxicology studies.

Immune Response

Immune Response Pharmacokinetics Clinical Trials Therapies

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

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA

FDA Science Biosimilars Clinical Trials

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology.

Vaccine

Vaccine Therapies Trials Clinical Trials

Rezafungin

New Drug Approvals

MAY 14, 2025

7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] Albanell-Fernndez M (January 2025). Grasselli Kmet N, Luzzati R, Monticelli J, Babich S, Conti J, Bella SD (March 2025). New Drug Therapy Approvals 2023 (PDF). 23 March 2023.

Pharmacokinetics

Pharmacokinetics FDA FDA Approval Treatment

Revumenib

New Drug Approvals

APRIL 21, 2025

3] The US Food and Drug Administration (FDA) granted the application for revumenib priority review , breakthrough therapy , and orphan drug designations. [3] New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025. 7] It is sold under the brand name Revuforj. [1] 1 October 2024.

FDA Approval

FDA Approval FDA Clinical Trials Pharmaceuticals

Omaveloxolone

New Drug Approvals

MAY 11, 2025

Retrieved 17 April 2025. Jump up to: a b New Drug Therapy Approvals 2023 (PDF). 2] [5] It is taken by mouth. [2] 5] Omaveloxolone was approved for medical use in the United States in February 2023, [2] [5] [6] [7] [8] and in the European Union in February 2024. [3] 9] SYNTHESIS PATENT Sheikh, AY et al. 2] [5] It is taken by mouth. [2]

FDA

FDA FDA Approval Disease Production

ETRIPAMIL

New Drug Approvals

MAY 27, 2025

Cardiovascular and Pharmacokinetic Profiles of Intravenous Etripamil in Conscious Telemetered Cynomolgus Monkeys. 2025 Apr 1:10915818251327963. ETRIPAMIL CAS 1593673-23-4 AS ACETATE 512.64 ETRIPAMIL CAS 1593673-23-4 AS ACETATE 512.64 Ascah A, et al. Int J Toxicol. Content Brief] [4]. Pion J, et al.

Pharmaceuticals

Pharmaceuticals Small Molecule Pharmacokinetics Treatment

LB-102: Redefining schizophrenia treatment in drug discovery

Drug Target Review

APRIL 21, 2025

LB Pharmaceuticals is making significant strides in the field of drug discovery, particularly in the development of therapies for neuropsychiatric diseases such as schizophrenia. 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 Clinical Trials Trials

Building better drugs: how 3D models are shaping pre-clinical development

Drug Target Review

APRIL 25, 2025

17 Highly human target-specific biologics pose several other safety challenges including antibody drug conjugates (ADCs), adeno-associated virus (AAV) gene therapy and ASO-induced thrombocytopenia, CAR-T-induced cytokine release syndrome, ADC-induced peripheral neuropathies and AAV-induced immune-mediated DILI. 2024 [cited 2025 Apr 16].

Clinical Development

Clinical Development Small Molecule Drugs FDA Approval

Iomeprol

New Drug Approvals

APRIL 18, 2025

New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. . ^ Jump up to: a b “Novel Drug Approvals for 2024” U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024. ^ Food and Drug Administration (FDA) (Report).

FDA

FDA Production FDA Approval Clinical Pharmacology

Acoramidis

New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2] Acoramidis was authorized for medical use in the European Union in February 2025. [2] 11 February 2025. Retrieved 16 February 2025. New Drug Therapy Approvals 2024 (PDF).

FDA Approval

FDA Approval FDA Production Treatment

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

After decades of research into therapies and preventive measures, though, global AIDS deaths have now fallen to about 600,000 annually. In January 2025, the incoming Trump administration issued a 90-day freeze on PEPFAR while it conducts a “programmatic efficiencies” review. ” Asimov Press (2025).

Clinical Trials

Clinical Trials Virus Vaccine DNA

Drug Discovery Digest

Therapeutic Oligos 2025 Keynote Speakers Announced

Novo Nordisk: Phase 3 Data Shows Mim8 Well-Tolerated After Switch from Emicizumab in Hemophilia A

Trending Sources

A spatial approach to understanding drug dynamics using mass spectrometry imaging

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

BeOne Medicines Gains CHMP Backing for BRUKINSA Tablet Formulation

Amgen Unveils Phase 2 Obesity Trial Results for Monthly Maritide at ADA’s 85th Scientific Sessions

FDA Approves Tablet Form of BeOne’s BRUKINSA® for All Indications

Time for change: non-human primates in drug research

Amgen to Present Phase 2 Maritide Data at ADA 85th Scientific Sessions

Crinecerfont

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study

Salt Lake City

Landiolol

Gretchen Green

Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution

Informed Design of Bioanalytical PCR Assay Testing Parameters

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

ATICAPRANT

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

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

Best Practices for Preclinical Dose Range Finding Studies

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

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Rezafungin

Revumenib

Omaveloxolone

ETRIPAMIL

LB-102: Redefining schizophrenia treatment in drug discovery

Building better drugs: how 3D models are shaping pre-clinical development

Iomeprol

Acoramidis

Making a “Miracle” HIV Medicine

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