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First patient dosed with antibody drug conjugate for HER2+ solid tumours

Drug Discovery World

The second, dose-expansion, phase of the study (Phase Ib) is to further evaluate the safety, pharmacokinetics / pharmacodynamics, and efficacy of IKS014 at the recommended Phase II dose. The Phase Ib trial is expected to read out in the second half of 2025.

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Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. Prescription Drug User Fee Rates for Fiscal Year 2025.

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Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type. There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025.

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Mission awarded $5.2m for disease-modifying Parkinson’s treatment

Drug Discovery World

The funding will help advance Mission’s potential disease-modifying treatment for Parkinson’s disease (PD), MTX325. Patient dosing is expected to start early in 2025. for disease-modifying Parkinson’s treatment appeared first on Drug Discovery World (DDW). Mission Therapeutics has been awarded $5.2 million from The Michael J.

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Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

This assessment is due to be published for public comment by June 30, 2025 , will a public meeting to be held by September 30, 2025 “to discuss the report, its findings, and the Agency’s specific plans to address the report recommendations.” FDA has previously worked with ACMT. Read the full AgencyIQ analysis here.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

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Major depressive disorder drug progresses to Phase II trials

Drug Discovery World

Alto Neuroscience has initiated a Phase II study to determine the pharmacodynamic effects of ALTO-203 in major depressive disorder (MDD) patients, as well as assess its safety, tolerability, and pharmacokinetics. To date, ALTO-203 has demonstrated positive emotional and cognitive effects in healthy participants after a single dose.

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