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Astellas Plots Near-Term Moves to Execute Long-Term Vision in Gene Therapy

Astellas has become an active player in gene therapy. MedCity News caught up with company executive Richard Wilson, who explained Astellas’s strategy, the clinical holds on its two most advanced programs, and the rationale behind its recent gene therapy deals.
United Kingdom Selecta Biosciences Richard Wilson Taysha Gene Therapies Dyno Therapeutics Massachusetts Based Dyno

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BlackCat Ransomware Gang Hits NextGen Healthcare, Becomes Even More Formidable Threat

Ransomware group BlackCat has been targeting healthcare organizations in recent months, and it just went after NextGen Healthcare. Healthcare organizations would be wise to enhance their cybersecurity strategy in defense against BlackCat, as it is “one of the more adaptable ransomware operations in the world,” according to HHS.
United States Bureau Of Investigation Washington Post Department Of Health Human Services Federal Bureau Of Investigation

Top 5 FDA considerations for medtech-enabled data platforms

Medtech companies should have a team of FDA advisors at the ready to develop and implement pre- and post-market strategies, prevent and resolve pre- or post-market issues and guide lifecycle management
Risk Categorization For Software Ai Device Software Functions Draft Guidance Categorization Of Digital Health Products Clinical Decision Support Software Final Guidance Digital Health Products Regulatory Concerns

Gut Punch: Finch's Flagging Microbiome Program Folds, Leading to 95% Staff Cut

Clinical trial setbacks and financial challenges have led Finch Therapeutics to stop a Phase 3 study for its lead microbiome program, a potential treatment for recurrent C. diff infection. As Finch seeks buyers for its remaining assets, the biotech is laying off most of its staff in a corporate restructuring.
Mark Smith Massachusetts Based Finch Seres Therapeutics Weight Loss Medical Devices Healthcare Innovation

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