Ionis Pharma’s Drug for Rare Disease With No Approved Therapies Meets Goals of Pivotal Study

Ionis Pharmaceuticals plans a 2026 FDA submission for zilganersen as a treatment for Alexander disease, an ultra-rare inherited neurological disorder. The antisense oligonucleotide developer has been moving toward commercializing drugs on its own rather than seeking partners. The post Ionis Pharma’s Drug for Rare Disease With No Approved Therapies Meets Goals of Pivotal Study appeared…

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Florida Medical Device Maker Exactech Declares Bankruptcy

Exactech, a Florida device manufacturer that faces more than 2,000 state and federal lawsuits from patients who allege the company sold defective hip and knee implants, filed for bankruptcy protection Tuesday. The Gainesville-based company said in a statement it was restructuring and would be sold to an investor group of private equity and “alternative asset”…

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Sen. Ron Wyden Seeks Answers on RFK Jr.’s Purge of FOIA Staff

The Department of Health and Human Services’ mass dismissals of workers who release government records “raise grave transparency, accountability, and privacy concerns,” Oregon Sen. Ron Wyden said Thursday. In a May 8 letter to HHS Secretary Robert F. Kennedy Jr. provided exclusively to KFF Health News, Wyden, the top Democrat on the powerful Senate Finance…

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Attention Healthcare and Life Science Startups: Deadline for INVEST Pitch Perfect Contest Submissions is Feb 21

We’re looking for biopharma startups focused on infectious diseases, medtech/diagnostics startups supporting chronic disease management, and health tech startups seeking to improve care navigation and coordination and developing AI tech. The post Attention Healthcare and Life Science Startups: Deadline for INVEST Pitch Perfect Contest Submissions is Feb 21 appeared first on MedCity News.

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Augmenting Brain Power: Real-World Data, Advanced Analytics, and the Future of Clinical Trials

The application of AI technology is part of a carefully orchestrated effort dependent on human intelligence, and the collaboration of physicians, disease-specific specialists, nurses, data scientists, and technologists. Done right, these efforts can lead to profound benefits, and offer a promising future for clinical research and patient care. The post Augmenting Brain Power: Real-World Data, Advanced…

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