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Industrial-Academic Group to Develop AI Models for Drug Toxicity Prediction

Industrial-Academic Group to Develop AI Models for Drug Toxicity Prediction

Inductive Bio, in collaboration with Amgen, Cincinnati Children’s Hospital, Baylor College of Medicine, and Torch Bio, has received up to $21 million to develop AI models for predicting drug toxicity. This project, under the DATAMAP initiative, aims to create human biology-based models to improve drug safety and reduce reliance on animal testing. The initiative is funded by the Advanced Research Projects Agency for Health (ARPA-H) and focuses on drug-induced liver injury and cardiotoxicity. The project will use advanced organoids and human tissue systems to generate data, which will be used to build AI models for toxicity prediction.
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FDA opens safety review of injectable RSV drugs approved for babies and toddlers

FDA opens safety review of injectable RSV drugs approved for babies and toddlers

Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV virus
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FDA's Accelerated Approval Program Faces Calls for Consistency Amid Rare Disease Drug Developments

FDA's Accelerated Approval Program Faces Calls for Consistency Amid Rare Disease Drug Developments

The FDA's Accelerated Approval program, designed to expedite drug development for serious conditions, is under scrutiny as rare disease leaders call for a more consistent approval process. The program, initially implemented in 1992 during the HIV/AIDS crisis, aims to address unmet medical needs. However, recent developments have highlighted inconsistencies, with some drugs receiving approval while others are rejected. Notably, UniQure's gene therapy for Huntington's disease is in limbo, raising concerns about the program's reliability. Experts argue for a standardized approach to ensure fair treatment across various rare diseases.
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Tessel Biosciences Secures $4.2M ARPA-H Grant to Enhance Drug Safety and ADMET Prediction

Tessel Biosciences Secures $4.2M ARPA-H Grant to Enhance Drug Safety and ADMET Prediction

Tessel Biosciences Secures $4.2M ARPA-H Grant to Enhance Drug Safety and ADMET Prediction
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EpiVax and FDA Study Highlights Immunogenicity Risks in Generic Teriparatide

EpiVax and FDA Study Highlights Immunogenicity Risks in Generic Teriparatide

EpiVax, in collaboration with the FDA and CUBRC, has published a study assessing the immunogenicity risks of peptide-related impurities in generic teriparatide products. The study utilized computational and experimental methods to evaluate the potential for these impurities to trigger unwanted immune responses. Findings indicated that certain impurities had higher predicted immunogenic potential than the reference teriparatide sequence, which could impact the safety and efficacy of generic peptide drugs. The study provides a framework for assessing and mitigating immunogenicity risks in generic peptide development.
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Biogen and Stoke Therapeutics Report Promising Results for Epilepsy Drug Zorevunersen

Biogen and Stoke Therapeutics Report Promising Results for Epilepsy Drug Zorevunersen

Biogen and Stoke Therapeutics have announced promising results from their investigational drug zorevunersen, which is being developed for the treatment of Dravet syndrome, a rare form of epilepsy. The companies presented data at the American Epilepsy Society meeting, showing that patients treated with zorevunersen experienced a significant reduction in major motor seizures. Specifically, a study revealed an 82% drop in seizures among patients receiving the drug, compared to a 20% reduction in a control group. The treatment also showed improvements in cognitive and behavioral measures. These findings suggest that zorevunersen could become a blockbuster drug, with potential regulatory activity expected next year.
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PureTech Advances Deupirfenidone for Idiopathic Pulmonary Fibrosis with FDA Support

PureTech Advances Deupirfenidone for Idiopathic Pulmonary Fibrosis with FDA Support

PureTech Health has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its drug candidate deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF). The FDA's feedback supports the advancement of deupirfenidone into a pivotal Phase 3 trial, which is set to begin in the first half of 2026. Deupirfenidone is being developed by Celea Therapeutics, a PureTech Founded Entity, and aims to become a new standard of care for IPF, a progressive and fatal lung disease. The Phase 3 SURPASS-IPF trial will compare deupirfenidone to pirfenidone, an existing FDA-approved therapy, to assess its efficacy and safety.
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Cosmo Pharmaceuticals' Baldness Treatment Shows Promising Phase III Results

Cosmo Pharmaceuticals' Baldness Treatment Shows Promising Phase III Results

Cosmo Pharmaceuticals' Baldness Treatment Shows Promising Phase III Results
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FDA Qualifies PathAI's AIM-MASH Tool, Revolutionizing MASH Clinical Trials

FDA Qualifies PathAI's AIM-MASH Tool, Revolutionizing MASH Clinical Trials

PathAI has achieved a significant milestone with the FDA qualification of its AIM-MASH AI Assist tool, marking it as the first AI-powered pathology biomarker to receive such status under the FDA's Drug Development Tool program. This follows a similar qualification from the European Medicines Agency, establishing AIM-MASH as the first tool with dual U.S. and EU regulatory recognition. The tool addresses variability in MASH clinical trials by standardizing liver biopsy scoring, thus reducing human variability and enabling more accurate enrollment and endpoint assessment.
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Recursion Pharmaceuticals Reports Positive Trial Data for AI-Discovered Drug in Rare Cancer Condition

Recursion Pharmaceuticals Reports Positive Trial Data for AI-Discovered Drug in Rare Cancer Condition

Recursion Pharmaceuticals Reports Positive Trial Data for AI-Discovered Drug in Rare Cancer Condition
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Transpire Bio's Florida Facility Passes FDA Pre-Approval Inspection

Transpire Bio's Florida Facility Passes FDA Pre-Approval Inspection

Transpire Bio's Florida Facility Passes FDA Pre-Approval Inspection
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Regeneron Advances Lynozyfic for Untreated Multiple Myeloma with Promising Study Results

Regeneron Advances Lynozyfic for Untreated Multiple Myeloma with Promising Study Results

Regeneron Advances Lynozyfic for Untreated Multiple Myeloma with Promising Study Results