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The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and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

European Pharmaceutical Review

JULY 13, 2023

1 Europe, however, is well placed to become a leader in driving the clinical translation of medications that display significant promise in laboratory-based studies. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. Expert Review of Clinical Pharmacology.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

Express Pharma

MARCH 21, 2023

In September 2022, Zydus had announced positive Phase 2 proof-of-concept (POC) study in CAPS patients, and the publication of Phase 1 study results in Clinical Pharmacology in Drug Development, supporting the advancement of ZYIL1 into pivotal clinical trials in CAPS patients.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development 52

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 PPD is an extremely common psychological condition affecting women after labour.

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

Pharmaceutical Technology

DECEMBER 16, 2022

Pharmaceutical Technology lists some of the top events in the tropical disease arena in 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 105

Drug Development Vaccines Clinical Pharmacology Compounding 105

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

Considering that, the safety data generated during clinical trials may not capture all possible delayed adverse events.” In this gene therapy guidance, FDA states that: “the recommended [long-term follow-up]. The long-term follow-up study could be a component of the pharmacovigilance plan.

Clinical Pharmacology 64

Clinical Pharmacology Communication Drug Development 64