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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.

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What you should know about the FDA’s Biological License Application Process

Reprocell

The biological license application (BLA) is one of the many requests for marketing approval received by the FDA. Unlike the New Drug Application (NDA) which is usually the go-to submission for chemically synthesized, low molecular weight drugs BLAs grant sponsors the ability to introduce Biologics into interstate commerce.

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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. Easier market entry: Less dense thickets may make it easier for new players to enter markets.

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Avacta Announces License Agreement With POINT Biopharma Inc.

The Pharma Data

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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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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UK’S MHRA GRANTS MARKETING AUTHORISATION FOR PFIZER’S CIBINQO® (ABROCITINIB) FOR.

The Pharma Data

This is the first marketing authorization globally for abrocitinib-. This is the first marketing authorization globally for abrocitinib-. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. This is the first marketing authorization worldwide for this treatment. “We

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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….