FDA

Cell Surgical Network Wins Case

Judge Jesus Bernal ruled in federal court in California’s Central District against the FDA’s argument that a group of stem cell clinics called the Cell Surgical Network, led by Mark Berman and Elliot Lander, were selling unapproved drug products in the form of adipose or fat cell mixtures. See the ruling here.

Comparative genomics of mortal and immortal cnidarians unveils novel keys behind rejuvenation

While aging affects most living organisms, the hydrozoan Turritopsis dohrniiis the only species able to rejuvenate repeatedly after sexual reproduction, becoming biologically immortal. Setting the whole-genome of this metazoan is indispensable to study in depth mechanisms responsible for its immortal phenotype. Here, we report the genome assembly of T. dohrniiand its congeneric species Turritopsis rubra, …

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FDA grants fast track designation to donor-derived CAR-T for advanced kidney cancer

The FDA granted fast track designation to ALLO-316, an investigational chimeric antigen receptor T-cell therapy, for the treatment of adults with advanced or metastatic clear cell renal cell carcinoma. ALLO-316 (Allogene Therapeutics) is an allogeneic, gene-edited CAR T-cell therapy that targets the protein CD70 on the surface of cancer cells. The agent is derived from …

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FDA Issues Draft Guidances on Real-World Evidence, Prepares to Publish More in Future

Collection and analysis of real-world data (RWD) continue to gain traction in the biomedical community, accompanied by a growing understanding of RWD’s strengths and limitations. Increased collection of RWD is leading to the generation of real-world evidence (RWE) that can potentially inform regulatory decisions regarding the safety and effectiveness of medical therapies. Such regulatory decisions …

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FDA-EMA Parallel Scientific Advice (PSA) Webinar

As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The Parallel Scientific Advice (PSA) program shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provides a mechanism for experts to concurrently engage in …

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FDA Regenerative Medicine Webinar

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a public webinar on Wednesday, March 9, 2022, from 11:00 a.m. – 12:00 p.m. ET. The webinar, The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases, will bring together patients, caregivers, advocates, and …

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