Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication […]
Neurological
Pear Therapeutics touts 9-month data for reSET-O
Pear Therapeutics today touted results from an extended retrospective analysis of real-world data for its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics developed its reSET-O prescription digital therapeutic (PDT) for treating opioid use disorder (OUD). According to a news release, results from the nine-month real-world data analysis demonstrated a continued long-term reduction in costly healthcare […]
Europe approves Roche’s Enspryng subcutaneous NMOSD treatment
Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Approval comes for the treatment as a monotherapy or for use in […]
Pear Therapeutics to go public via merger with SPAC
Prescription digital therapeutics pioneer Pear Therapeutics announced today that it will go public by merging with a SPAC called Thimble Point Acquisition Corp. Boston-based Pear Therapeutics’ combination with the special purpose acquisition company (SPAC), whose management team is associated with the Pritzker Vlock Family Office, will result in a combined company named Pear Holdings Corp. […]
Ananda Scientific enrolls first patient in Liquid Structure CBD trial for treating PTSD
Ananda Scientific announced today that it enrolled the first patient in a trial evaluating its Liquid Structure delivery system for treating PTSD. In collaboration with the NYU Grossman School of Medicine, Ananda’s clinical trial will evaluate Nantheia A1002N5S, an investigational drug that uses cannabidiol (CBD) in Ananda’s proprietary Liquid Structure delivery technology to treat post-traumatic […]
Noveome Biotherapeutics inks licensing deal for SipNose drug delivery device
Noveome Biotherapeutics announced that it entered a commercial license agreement to use SipNose’s proprietary drug delivery device. Yokneam, Israel–based SipNose develops its intranasal Cribriform Targeted Device (CT6), which, under the agreement, was licensed to Noveome to deliver the Pittsburgh-based company’s ST266 biologic to the central nervous systems, according to a news release. CT6 allows aerosolized […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery. Among the […]
Bexson Biomedical wins U.S. patent for ketamine formulation
Bexson Biomedical announced that the U.S. Patent and Trademark Office (USPTO) granted a patent for its BB106 ketamine therapy. Santa Barbara, Calif.-based Bexson’s patent describes pharmaceutical formulations and treatment methods for the ketamine therapy, which the company believes allows for safety, comfort and pharmacokinetics that improve the administration of ketamine through multiple avenues, including the […]
Delpor doses first patient in once-yearly risperidone implant trial
Delpor announced today that it dosed the first patient in a Phase 1b/2a clinical trial for its DLP-114 risperidone implant. DLP-114 is a long-acting formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. The open-label study is to evaluate the safety, tolerability and pharmacokinetics of switching from oral risperidone to the once- or twice-yearly DLP-114 […]
Lyndra Therapeutics touts Phase 2 data for oral schizophrenia treatment
Lyndra Therapeutics yesterday announced positive results from a Phase 2 study of its once-weekly, oral schizophrenia treatment. Watertown, Mass.-based Lyndra’s oral, long-acting, extended-release risperidone capsule, LYN-005, is designed for the weekly treatment of schizophrenia. Data from the company’s first repeat-dose Phase 2 study demonstrate that LYN-005 offered sustained therapeutic levels of risperidone over the one-week […]
