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Latest From CellTrans, Inc.

Getting To Global Is A Hurdle For Cell And Gene Therapies

Only three of the 10 new therapies approved by the US FDA also have been approved in the European Union, while both of the EU gene therapy approvals followed FDA clearance, a Pink Sheet analysis shows.

Regional Comparisons Gene Therapy

Vertex Expands Trial As Type 1 Diabetes Cell Therapy Hits New Milestones

VX-880 is the first iteration of a cell therapy strategy which Vertex believes can bring curative treatment for Type 1 diabetes, but competition in this field is building.

Clinical Trials Companies

US FDA Open To ‘Compromise’ In Regulating Pancreatic Islet Cell Transplantation

FDA’s Peter Marks says there may be a way to reduce the regulatory burden for pancreatic islet cell treatment for diabetes. Researchers in Canada and Europe note access to therapy is limited in the US since FDA regulates islet cells as a drug while other countries regulate them as a tissue or organ.

FDA Market Access

Lantidra Chronology: 19 Years From IND Submission To Approval For The Cellular Therapy

Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of CellTrans’ treatment for type 1 diabetes.

Drug Review Profile Regenerative Medicine
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