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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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

DrugBank

OCTOBER 17, 2024

Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drug development lifecycle. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.

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Drug Development Metabolic Stability Clinical Trials Drugs 98

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

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International Laboratories Drugs Pharmacokinetics 52

DrugBank

MARCH 7, 2024

The Quest for Ozempic-Like Alternatives Ozempic, a GLP-1 receptor agonist developed by Novo Nordisk, has demonstrated remarkable efficacy in promoting weight loss and improving metabolic health. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 98

Drug Target Review

SEPTEMBER 19, 2023

In addition, these models at the current state are better for short term tests, over a week or two and cannot be used for acquiring data from long term drug exposures. Miniature organs as test beds for new drugs Organoids are miniature human organs with clusters of cells derived from stem cells and mimic specific tissues.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

DrugBank

FEBRUARY 12, 2025

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. This necessitates exploring alternative strategies to expedite drug discovery and optimize resource allocation.

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Cell Based Assays Drugs Pharmacokinetics Disease 52

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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