PharmaShots

APRIL 6, 2023

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

Biosimilars

pharmaphorum

NOVEMBER 1, 2022

Date: 8 – 9 February 2023. In 2023 we will see the return of SAE’s RNA Therapeutics conference to a live in-person event, showcasing an update on mRNA therapeutic applications, coupled with an industry outlook of the field. Director, Clinical Pharmacology. Clinical Science Director. 14th Annual RNA Therapeutics.

Clinical Pharmacology

FDA Law Blog: Biosimilars

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

Clinical Pharmacology

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling

RX Note

JANUARY 21, 2023

Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)

Compounding

European Pharmaceutical Review

JULY 18, 2024

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. Exploration of the antibody–drug conjugate clinical landscape. 2023; 3 Tsuchikama et al. 2023;15(1) Shastry et al. Rise of Antibody-Drug Conjugates: The Present and Future.

Chemotherapy

European Pharmaceutical Review

MAY 2, 2023

He received an MD from the Georg August University of Göttingen and completed a postdoctoral Master’s in Medical Sciences Clinical Pharmacology at the University of Glasgow. Dr Mieke Borgs has been Head of Clinical Operations Europe at BeiGene since May 2020. cited 2023 Apr 4]. 2019 [cited 2023 Apr 4].

Clinical Pharmacology

European Pharmaceutical Review

MARCH 11, 2024

In fact, a study published in 2023 in The Lancet HIV revealed that women and men with HIV at age 40 had an average of 39 and 37 years of life left, respectively – only a few years less than that of the general population – if they started antiretroviral therapy (ART) after 2015. Internet] 2023. References 1. World Health Organization.

Immunity

Putting Patients First Blog

SEPTEMBER 26, 2024

Clinical Pharmacology & Therapeutics , 97(3) , 263–273. Participation of women in clinical trials supporting FDA approval of cardiovascular drugs. Barriers and facilitators to the recruitment of disabled people to clinical trials: A scoping review. Pacanowski, M., and Zhang, L. 8 Scott, P., Jenkins, M., Southworth, M.,

Communication

Pharmaceutical Technology

DECEMBER 16, 2022

This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology.

Drug Development

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). This guidance finalizes a draft guidance issued in February 2023.

Clinical Pharmacology