Regulatory intelligence: Update on regenerative medicine advanced therapies designations

This article discusses the scope and purpose of the special designation for Regenerative Medicine Advanced Therapies (RMAT) created by the passage of the 21st Century Cures Act. The authors explain the benefits expected to be realized with RMAT, such as keeping the US globally competitive in the field. They provide a tally of products receiving the special

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Using CAR T-cell Therapy in Older Patients With Aggressive Lymphoma

Article Highlights CAR T-cell therapy is gaining traction in relapsed/refractory lymphoma in older patients with aggressive disease. As a result of prospective trials investigating CAR T-cell therapy, there is potential that older patients with lymphoma can be spared multiple lines of chemotherapy and its resultant toxicities while still having long-term clinical benefit. Toxicities are still

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ASCO 2019: Adding ribociclib to first-line endocrine therapy significantly improves survival for pre-menopausal women with advanced breast cancer

The international, randomised phase III MONALEESA-7 trial found that adding ribociclib to standard-of-care endocrine therapy significantly improved overall survival for premenopausal women with advanced HR-positive/HER2-negative breast cancer compared with endocrine therapy alone. After 42 months of follow-up, the survival rate was 70% for women who took the combination therapy compared with 46% for women who

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Back-and-forth exchanges boost children’s brain response to language

Study finds engaging young children in conversation is more important for brain development than “dumping words” on them. A landmark 1995 study found that children from higher-income families hear about 30 million more words during their first three years of life than children from lower-income families. This “30-million-word gap” correlates with significant differences in tests

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Advanced Therapies News

Source ARM Organovo Collaborates With MCRI and Leiden University Medical Center to Develop Stem Cell-Based Bioprinted Tissue Treatments for Kidney DiseaseMay 30, 2019 – (Organovo) – This multi-organizational effort integrates Organovo’s leading bioprinting platform with MCRI’s advanced stem cell differentiation technology and LUMC’s cell lines and clinical expertise.  The collaboration has been made possible through generous

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Orchard Therapeutics, Fondazione Telethon and Ospedale San Raffaele Announce Exclusive Worldwide License Agreement for the Treatment of MPS-I

Encouraging Clinical Data Generated from Ongoing Proof-of-Concept Study Conducted by the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget); Enrollment Expected to Complete in the First Half of 2020 Leverages Orchard’s Expertise in Treating Neurometabolic Diseases Using its Investigational Autologous Hematopoietic Stem Cell Gene Therapy Builds Upon Orchard / SR-Tiget Partnership to Develop Novel Gene Therapy Candidates Orchard Therapeutics, Fondazione

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Organovo Collaborates With MCRI and Leiden University Medical Center to Develop Stem Cell-Based Bioprinted Tissue Treatments for Kidney Disease

Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious diseases, today announced a collaboration with Professor Melissa Little at the Murdoch Children’s Research Institute (“MCRI”), The Royal Children’s Hospital, Melbourne, Australia and Ton Rabelink at Universiteit Leiden (“LUMC”), Leiden, Netherlands. The project will expand the use of 3D bioprinted stem

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