Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Clinical Pharmacology & Therapeutics , 111(3), 531538. Freyr Solutions.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics.

FDA 62

FDA Clinical Trials Treatment Trials 62

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] It first appeared in the scientific literature in 2010 or 2011. [16]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

FDA 52

FDA Biosimilars Science Drugs 52

The Pharma Data

FEBRUARY 8, 2021

FDA on April 28, 2011 and by the European Commission on September 7, 2011. in 2011, ZYTIGA ® has been approved in combination with prednisone or prednisolone, in more than 100 countries. About the Janssen Pharmaceutical Companies of Johnson & Johnson. FDA on February 8, 2018. [vi] Learn more at www.janssen.com.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52