Category REGENERATIVE MEDICINE

Chronic Low Back Pain Study Results Indicate Benefit With Tanezumab

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

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FDA Encourages Development of Regenerative Medicines

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

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Institute for Clinical and Economic Review’s Assessment Finds Spinraza and Zolgensma Provide Substantial Health Benefits for People with Spinal Muscular Atrophy

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

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‘Off-the-shelf’ CAR-Ts have an important role to play – but are they ready for prime time?

Allogeneic CAR-Ts could serve an important niche – particularly for patients who can’t receive autologous CAR-Ts – but the earliness of the data makes conclusions tough to draw. Since their transition from small, academic clinical trials to commercial production, CAR-T cell therapies have won recognition as a novel and highly effective therapeutic modality, particularly in

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