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CereVasc Completes Patient Enrolment in ETCHES 1 Study of eShunt System for Communicating Hydrocephalus
Shots: CereVasc completed enrollment in the ETCHES-1 Study evaluating its eShunt System in adults with communicating hydrocephalus resulting from elevated intracranial pressure following post-aneurysmal subarachnoid hemorrhage Study will assess changes in intracranial pressure, device performance & safety, with pts monitored for safety outcomes for up to 24mos. following the procedure eShunt System is designed to…
Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India 
    Shots:  Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India  Tishtha will be available in 100 mg and 40 mg strengths  Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   Ref: Zydus  | Image: Zydus |  Press Release  Related News: Shanghai Henlius Receives the US FDA…
Trisol Medical Reports US Early Feasibility Study Results on Transcatheter Tricuspid Valve Replacement (TTVR) System
Shots: The US Early Feasibility Study assessed TTVR system in 22 pts with severe to torrential tricuspid regurgitation; enrollment in the trans-jugular cohort is complete, with the study continuing via Trisol’s newly developed trans-femoral access route Safety outcomes showed <5% permanent pacemaker need at 30 days, with considerable reduction in tricuspid regurgitation following implantation At 30 days…
Ionis and Otsuka
The EC Approves Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)
Shots: The EC has approved Dawnzera (SC autoinjector; Q4W/Q8W) for the routine prevention of HAE attacks in pts (≥12yrs.) Approval was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate, with 94% overall mean monthly reduction at 1yr. in the OASISplus OLE study Approval…
Insilico Medicine and Hygtia Therapeutics Partner to Advance ISM8969 for CNS Disorders
Shots: Insilico Medicine & Hygtia Therapeutics have entered into a co-development global collaboration agreement for Insilico's ISM8969 program for CNS disorders As per the deal, Hygtia will receive 50% worldwide rights to research, develop, register, manufacture, & commercialize ISM8969 in exchange for ~$66M, incl. milestone payments & $10M initial upfront payment Under the agreement, Insilico…
SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System
Shots: The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…
GSK and Shionogi Restructure ViiV Healthcare Ownership as Pfizer Exits
Shots: GSK & Shionogi, together with Pfizer, have agreed to replace Pfizer’s 11.7% economic interest in ViiV Healthcare with an investment by Shionogi, reshaping the ownership structure of ViiV Healthcare As per the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125B, cancel Pfizer’s stake, pay Pfizer $1.875B, & distribute a $0.25B special…