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How AI will reshape pharma by 2025

Drug Target Review

Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. Looking ahead, 2025 could represent a major turning point for the pharmaceutical sector.

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The future of CNS drug development: signs of real progress

Drug Target Review

Developers and sponsors working on biologically derived therapies in the US can utilise the Regenerative Medicine Advanced Therapy (RMAT) designation, which regulators grant to promising regenerative therapies. The blood–brain barrier: Structure, regulation and drug delivery. Adv Drug Deliv Rev. 2020;165-166:1-14. doi: 10.1016/j.addr.2019.11.009.

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2025: Perspectives and Predictions From Advarra Thought Leaders

Advarra

Over the years, these agencies have made significant strides in aligning their rules and guidance, as seen with the harmonized definition of an institutional review board (IRB), informed consent, and the recent implementation of the single IRB (sIRB) model. Global site networks offer a similar benefit.

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BioMarin Completes Acquisition of Inozyme Pharma

The Pharma Data

BioMarin Finalizes Acquisition of Inozyme Pharma, Strengthening Rare Disease Portfolio with INZ-701 BioMarin Pharmaceutical Inc. INZ-701 is designed to replace deficient ENPP1 enzyme activity, with the aim of restoring normal regulation of mineralization processes in the body. per share.

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Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health

FDA Law Blog: Biosimilars

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. CDRH’s long-standing definition of “valid scientific evidence” does not include opinions or beliefs.

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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CMS Definition of “New Formulation” Upheld in Federal Court

FDA Law Blog: Biosimilars

Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). Vanda Pharmaceuticals, Inc. See our memo summarizing CMS’s regulation here. All of these products are line extensions under CMS’s definition.

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