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Bio-Techne Joins Forces with USP to Speed Up Development of mAbs and Gene Therapies

The Pharma Data

This alliance aims to address mounting challenges in the development and commercialization of mAb therapies and gene therapies, particularly those involving AAV vectors. To date, more than 160 monoclonal antibody therapies targeting nearly 100 disease-related proteins have received regulatory approval globally.

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How GPCR-targeting therapies are advancing the fight against inflammatory disease

Drug Target Review

All these features make GPCRs central to regulating many vital biological processes in the body, including immune responses and inflammation, and thus especially attractive for therapeutic intervention. GPCR-targeting therapies such as DT-9046 represent a compelling opportunity in that respect, with major clinical and commercial potential.

Disease 59
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Analyzing biosimilar market dynamics in different patient populations

Drug Patent Watch

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

Notably, many of the issues regarding drugs are typically considered the practice of medicine, which FDA does not regulate. Therapies for chronic diseases, even in pediatrics, are not approved based on decades-long studies, and this is not likely to change.

Drugs 59
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Pharma Contract Sales Outlook 2025–2030: Multilingual Teams Drive Global Expansion

The Pharma Data

As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

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Congressional Hearing on LDTs: Split on FDA Regulation but Support for VALID

FDA Law Blog: Biosimilars

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Recent changes in drug approval processes, intellectual property laws, and pricing regulations have introduced both opportunities and challenges for dealmakers.