iPS Cells & Regenerative Medicine– category –
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Cartesian Therapeutics and WestGene Biopharma Announce Strategic Licensing Agreement to Accelerate In Vivo CAR T Platform Development for Autoimmune Diseases
BioSpace (Cartesian Therapeutics) USA Overview Cartesian Therapeutics announced a strategic licensing agreement with WestGene Biopharma to accelerate the development of novel in vivo Chimeric Antigen Receptor T-cell (CAR-T) therapies for... -
ENCell Secures US Clinical Manufacturing Contract for Ingenium Therapeutics’ NK Cell Therapy Gengleucel, Expanding Global CDMO Operations
Bio South Korea Overview ENCell, a South Korean CDMO specializing in cell and gene therapy, has signed an additional CMO contract with Ingenium Therapeutics for the manufacturing of clinical trial materials for its NK cell therapy candid... -
Alcami Expands CDMO Packaging Capabilities with Tjoapack Acquisition, Strengthening Cell and Gene Therapy Supply Chain
North Carolina Biotechnology Center USA Overview Alcami Corporation, a Contract Development and Manufacturing Organization (CDMO), has significantly expanded its packaging capabilities through the acquisition of global contract packaging... -
Made Scientific and Pluristyx Form Strategic Partnership to Integrate iPSC Technology and Expand Cell Therapy Manufacturing CDMO Services
BioPharm International USA Overview Made Scientific announced a strategic partnership with Pluristyx, an iPSC technology platform provider, to integrate iPSC technology into its cell therapy CDMO services. This collaboration will provide... -
FUJIFILM Cellular Dynamics Opens New iPSC Manufacturing Facility and Reorganizes Life Sciences Leadership to Accelerate Cell Therapy and iPSC Business Expansion
FUJIFILM Cellular Dynamics / Indian Pharma Post Japan Overview FUJIFILM Cellular Dynamics announced the opening of its new headquarters and iPSC development and manufacturing facility in Madison, tripling its iPSC-based research product ... -
Exosome Treatments in Aesthetics Remain FDA Unapproved with Safety Warnings: Emphasizing Evidence-Based Approaches
Aesthetic Med Guide USA Overview The U.S. FDA has reiterated that no exosome products are approved for aesthetic purposes and has issued a public safety alert against the use of unapproved products. This article details the scientific ba... -
FDA Expedited Pathway Guide: Strategic Selection of Fast Track, Breakthrough Therapy, and RMAT
Boyd Consultants USA Overview The FDA offers several expedited programs to accelerate innovative drug development, including Fast Track, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT). This article outlines the d... -
FDA Issues Draft Guidance to Streamline Regulatory Submissions for Cell and Gene Therapy Products by Leveraging Prior Knowledge
Pharmuni USA Overview The U.S. FDA has released new draft guidance aimed at accelerating the development of cell and gene therapy products for rare diseases. This guidance permits developers to leverage existing scientific, manufacturing... -
Stem Cell Therapies for Parkinson’s Disease Advance to Clinical Stages: BlueRock’s Phase 3 and Japanese iPSC Program Lead the Way
NeurologyLive USA Overview Stem cell therapies for Parkinson's Disease, particularly dopamine cell replacement trials, are making significant strides into advanced clinical stages. BlueRock Therapeutics' embryonic stem cell (ESC)-derived... -
BioCardia’s CardiAMP Autologous Cell Therapy Accelerates Towards Global Approval for Heart Failure
MerlinTrader (BioCardia分析) USA Overview BioCardia's CardiAMP autologous bone marrow cell therapy for cardiovascular disease has achieved significant regulatory milestones. The U.S. FDA confirmed that the ongoing Phase 3 CardiAMP Heart ...
