Alzheimer’s Disease (AD) represents a major and rapidly growing burden to the healthcare ecosystem. In the USA alone, some 5 million people suffer from the disease that costs the managed healthcare system in excess of $250 billion. Currently the sixth leading cause of death, AD prevalence has increased by 89% since 2000, underscoring the need
Approval from Japanese regulators means that trials of induced pluripotent stem cells can begin later this year. Scientists in Japan now have permission to inject ‘reprogrammed’ stem cells into people with spinal-cord injuries. An upcoming trial will mark the first time that induced pluripotent stem (iPS) cells have been used to treat spinal-cord injuries, after
Researchers have developed new smart fabric coated with polymer that can provide electricity for small, wearable devices. February 25, 2019 by P.M.Fornasari Many wearable biosensors, data transmitters and similar tech advances for personalized health monitoring have now been “creatively miniaturized,” says materials chemist Trisha Andrew at the University of Massachusetts Amherst, but they require a
Februray 25, 2019 P.M. Fornasari Tanezumab, an investigational subcutaneously-administered, non-opioid treatment, may benefit patients with moderate to severe chronic low back pain (CLBP), according to top-line results from a Phase 3 study. Study A4091059, a double-blind, placebo- and active-controlled study, included patients with moderate to severe CLBP who had persistent low back pain for more
February 25, 2019 P.M. Fornasari A task force of regenerative medicine experts established by the American Society of Interventional Pain Physicians (ASIPP) has formulated new guidelines for the safe and effective use of biologics in the management of low back pain. The guidelines, published in Pain Physician, are based on a review of the literature on the
The agency clarified the process for development programs for regenerative medicine therapies. Feb 20, 2019 By Pier Maria Fornasari FDA provided further details in February 2019 on how manufacturers may use expedited development programs for regenerative medicine therapies, clarifying that the category includes gene and Chimeric antigen receptor T cells (CAR-T) therapies, as well as cellular
Significant improvement in vision in first cohort of Phase II subjects in US trial of hRPC cell therapy in retinitis pigmentosa ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to provide an update on progress with the ongoing Phase I/II clinical trial of its hRPC cell
Current pricing of Spinraza would require a substantial discount to meet traditional cost-effectiveness ranges; Zolgensma’s value-based price range is between $310,000-$900,000 using standard methodology but as high as $1.5 million using alternative measures of health gain —— As with all treatments for ultra-rare conditions, judgments of overall value require consideration of contextual issues and broader
Highlights •Microbiome-derived NO promotes widespread S-nitrosylation of the host proteome •Interspecies S-nitrosylation regulates miRNAs, gene expression and host development •Microbiota control host function by shaping the post-translational landscape Summary Bioactive molecules can pass between microbiota and host to influence host cellular functions. However, general principles of interspecies communication have not been discovered. We show here
Advanced Therapies (Advanced Therapies Medicinal Products and Biologised Medical Devices – ATMP/bio-MD) are a potential game changer in health care: They aim to transform the current focus on “treatment of disease” into one that concentrates on “regeneration of health”. The unifying goal of RESTORE is the implementation of newly developed Advanced Therapies in clinical routine
