cell therapy
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Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy
NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
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Startup Syntax Bio Leverages CRISPR to Transform Cell Therapy Manufacturing
Syntax Bio’s technology platform uses CRISPR to direct stem cells to become a desired cell type in a process that’s more scalable and less expensive than current methods. The startup is raising a Series A round of financing to further demonstrate the potential of its technology.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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While Auto vs. Allo Cell Therapy Debate Continues, VCs Look for ‘Next Shiny Thing’
Allogeneic cell therapy hasn’t caught up to autologous cell therapy yet, and the disappointing data so far has soured the entire allogeneic field for at least one venture capitalist. The cell therapy debate was one of the topics covered during a panel discussion at the Biopharm America conference.
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Bayer Pushes Ahead With Parkinson’s Cell Therapy on Heels of Positive Phase 1 Data
A Bayer cell therapy for Parkinson’s disease has met primary and secondary goals of its first test in humans, and the pharmaceutical giant is now planning for a larger Phase 2 clinical trial expected to begin enrollment in the first half of next year.
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Precision Bio Offloads Lead Cell Therapy Program in Pivot to In Vivo Gene Editing
Imugene gains global rights to Precision BioSciences’ most advanced program, an allogeneic cell therapy for advanced cases of blood cancer. Precision will now focus on in vivo gene editing therapies, some of which is partnered with Novartis and Eli Lilly.
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Startup Tenpoint Lands $70M to Bring Vision-Restoring Cell Therapy to the Eye
Tenpoint Therapeutics’ name refers to the time it takes for an image to hit the retina and be processed by the brain. The regenerative medicine startup is developing cell therapies it hopes restore that vision capability for patients with degenerative eye disorders.
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A Startup Wins the First FDA Approval of a Cell Therapy for Type 1 Diabetes
CellTrans’s Lantidra is now the first FDA-approved cell therapy for type 1 diabetes. The therapy is made from islet cells sourced from deceased donors.
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Eli Lilly to Buy Sigilon, Betting the Biotech Can Overcome a Cell Therapy Limitation
Eli Lilly is expanding its diabetes prospects by acquiring cell therapy developer Sigilon Therapeutics. The two companies are already partners in the development of a type 1 diabetes cell therapy currently in preclinical development.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
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Patient Death Leads to Pause in Test of 2seventy Bio Cell Therapy for Leukemia
2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.
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ASCO Recap: Multiple Myeloma Moves, ADC Advances & Brain Cancer Progress
During the annual meeting of the American Society of Clinical Oncology, a cell therapy posted clinical data that could broaden its use in multiple myeloma. In other developments, the class of drugs called ADCs continue to make progress and a novel brain cancer drug has Phase 3 data that support its use as a new treatment option.
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AstraZeneca Teams Up With Startup Quell in Type 1 Diabetes, IBD Cell Therapy Pact
AstraZeneca is paying $85 million to kick off an alliance with Quell Therapeutics focused on developing new cell therapies for autoimmune diseases. Type 1 diabetes and inflammatory bowel disease are the focus of the research collaboration.
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Where Cell Therapies Are Going Next, and How Insurers Are Getting Ready
Multiple efforts are underway to improve cell therapies for cancer. During the MedCity News INVEST conference in Chicago, a panel discussed the future of cell therapies and what the industry doing to manage the financial risks of these new treatments.
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BioPharma, Sponsored Post, Startups
The Biopharma Startups Presenting at MedCity INVEST
Companies presenting their technology at the conference seek to support a diverse patient population spanning conditions such as inflammatory bowel disease, food allergies, and cancer. Cell, gene therapy and immunotherapies also form some of their treatment approaches in development.