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How do patent thickets vary across different countries

Drug Patent Watch

” These dense webs of overlapping patent rights can significantly impact innovation, market entry, and competition across various industries and countries. In this comprehensive article, we’ll explore how patent thickets vary across different countries and their implications for businesses, inventors, and policymakers worldwide.

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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Drug Patent Watch

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve….

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Market access of gene therapies across Europe, USA, and Canada: challenges, trends, and solutions

Drug Patent Watch

This article was first published by Elinevan Overbeeke, Sissel Michelsen, Mondher Toumi, Hilde Stevens, Mark Trusheim, Isabelle Huys, and StevenSimoens in Drug Discovery Today under a Creative Commons License. Highlights….

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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] 5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. The scientific article published in J. 1] It is taken orally. [1]

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Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

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Article EMA Thank You Swissmedic reorg adds new focus on medical device market surveillance

Agency IQ

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. KAROLINE MATHYS is the head of the new sector.

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Pirtobrutinib

New Drug Approvals

This article incorporates text from this source, which is in the public domain. This article incorporates text from this source, which is in the public domain. ^ “U.S. 4] Participants had a median of three prior lines of therapy, with 93% having two or more prior lines. [4] 27 January 2023. . 27 January 2023. 12 (5): 80.