FDA Law Blog: Biosimilars

JULY 17, 2024

clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g., In fact, at this Scientific Workshop, Frank called for the creation of an alternative effectiveness standard for ultra rare diseases that relies on all available scientifically valid evidence (e.g.,

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

Express Pharma

JANUARY 19, 2025

1162 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 18. DOI: 10.1002/cpdd.1162 DOI: 10.1002/cpdd.1318.

Clinical Pharmacology 111

Clinical Pharmacology Labelling Medical Schools Drug Development 111

European Pharmaceutical Review

SEPTEMBER 29, 2022

Brii Biosciences , a multi-national drug development company, has published top-line results from a Phase I study evaluating its long-acting, single-dose, intramuscularly injected drug BRII-296 in postpartum depression (PPD). “We

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

European Pharmaceutical Review

MARCH 11, 2024

As a physician scientist with knowledge and experience in translational medicine and late-stage drug development, Sherene has a proven record in drug development including successful regulatory interactions with US and international agencies.

Immunization 98

Immunization Immunity Clinical Pharmacology Drug Development 98

Putting Patients First Blog

SEPTEMBER 26, 2024

Further discussion on the unique aspects of rare disease drug development, the associated challenges, and when waivers may be warranted would greatly benefit all stakeholders, including sponsors, patient organizations, clinical researchers, and regulators. Clinical Pharmacology & Therapeutics , 97(3) , 263–273.

Communication 52

Communication Clinical Pharmacology Documentation Drug Development 52

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. The post 2022 in review: Drug development milestones for tropical diseases appeared first on Pharmaceutical Technology.

Drug Development 105

Drug Development Vaccines Clinical Pharmacology Compounding 105

pharmaphorum

NOVEMBER 4, 2020

The M&S approach should be integrative, from the molecular level to the clinical and population outcomes. It should be conceived both as a proof of concept tool and a MIDD (Model Informed Drug Development, to use the FDA jargon) tool for potential treatments, including vaccines, and combinations of drugs.

Vaccines 105

Vaccines Clinical Pharmacology Immunization Immunity 105

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

The Guidance notes that extrapolation of data across species is challenging; however, in accord with Agency pronouncements elsewhere on this topic, the Guidance describes FDA’s limited experience with alternative assays to characterize neurodevelopmental toxicity while expressing a theoretical openness to such methods when feasible.

Clinical Pharmacology 64

Clinical Pharmacology Communication Drug Development 64

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59