AMSBIO has announced the launch of GMP grade STEM-CELLBANKER® manufactured in strict compliance with Japanese, EU, US, and PICS good manufacturing practice guidelines. [Read more…]
Gamida Cell Receives Additional EMA Orphan Drug Designation for NiCord® in HSCT
Phase 3 study of NiCord commenced last month in blood cancer patients
Jerusalem, Israel, March 23, 2017 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) regarding NiCord® as a treatment for haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation (BMT).
“We are very encouraged that the EMA has widened NiCord’s orphan drug designation to include BMT, and believe it is an important recognition of the unmet needs in these indications,” said Gamida Cell president and CEO Dr. Yael Margolin. “This broadened regulatory designation adds a key layer of market exclusivity for NiCord as we move forward with our Phase 3 study and prepare for commercialization.” [Read more…]
Scalable Protocol to Differentiate Skeletal Muscle Cells from Stem Cells
AMSBIO announces the availability of the world’s first kit to differentiate human pluripotent stem cells into functional myotubes. The new kit utilizes a highly efficient media based protocol to produce skeletal muscle cells from stem cells in a simple, scalable manner. [Read more…]
Pluristem’s PLX-PAD Cells May Save $1B in Post-Op Costs for Hip Fracture
The lifetime prevalence of hip fracture in the U.S. is 10% for men and 20% for women. Incidence is expected to continue to rise, driven by an increasing elderly population. Even with today’s surgical repair techniques and post-operative care, at 6 months postinjury, only half of patients can perform their pre-fracture daily living activities.
At 1 year after hip fracture, older adults are five times more likely to be institutionalized than age-matched controls without hip fracture, and mmortality rates resulting from hip fracture range from 12% to 37% within the first year. In parallel, the cost to the U.S. healthcare system is also staggering, and amounts to between $10 and $15 billion annually. [Read more…]
Revolutionizing Asset Evaluation for Drug Development and Commercialization
Mirador Analytics has launched an online version of its prevalence-based Asset Evaluation Tool.
If you are engaged in New Product Planning, Drug Development, Launch Planning, Portfolio Prioritization, Life Cycle Management or working towards a specific transaction (e.g. license and/or investment), Mirador is positioned to advise you on how the Asset Evaluation Tool could support you through these processes. [Read more…]
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