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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

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. New Drug Application (NDA) : Needed for marketing approval of new drugs.

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Gepirone

New Drug Approvals

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] Jump up to: a b Fabre LF, Brown CS, Smith LC, Derogatis LR (May 2011). 1] It is taken orally. [1] 1] Gepirone acts as a partial agonist of the serotonin 5-HT 1A receptor. [1] 17 March 2016. 8 (5): 1411–1419.

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PRITELIVIR MESYLATE

New Drug Approvals

As a compound derived from the chemical class of thiazolylamides, pritelivir is active against both types of herpes simplex virus causing labial and genital herpes, respectively, and retains activity against viruses which have become resistant to marketed drugs. 152 (8): 1489–500. doi : 10.1007/s00705-007-0964-7. PMID 17404685. Field, H.J.;

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Sygnature Discovery Appoints New Chief Commercial Officer to Drive Next Phase of Business Growth

Sygnature Discovery

He will also spearhead the development and implementation of a dynamic go-to-market strategy, designed to leverage the group’s strengths and enhance customer relationships through an even more responsive and scientifically driven commercial organization.

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Natural Intelligence?

Molecular Design

It's not clear (at least to me) what the authors of H2024 mean by natural selection and at times their view of natural selection appears to be closer to Lysenkoism than Darwinism. The 'enrichments' calculated from the plot in the graphical abstract are underwhelming (the highest degree of enrichment is the 2014 value of just over 1.5-fold

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Optimizing Your Drug Patent Strategy: A Comprehensive Guide for Pharmaceutical Companies

Drug Patent Watch

This comprehensive guide will walk you through the intricacies of optimizing your drug patent strategy, ensuring that your innovations are safeguarded and your market position is strengthened. The First-to-File System Since the America Invents Act of 2011, the U.S. File too late, and you risk someone else beating you to the punch.

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AZVUDINE

New Drug Approvals

SYN [link] Azvudine was approved for the treatment of adult HIV-1 infection in China in 2021, and it was approved for conditional marketing for the treatment of SARS-CoV-2 in China in 2022. 2011, 46, 4178−83. (12) April 2011). September 2011). The structural characterization is shown in Figure 8. 12) Deng, W.; Jiang, S.;

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