Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

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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.

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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.

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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.

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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

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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. NHC comments on FDA diversity in clinical trials guidance.

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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.

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