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AbbVie Presents Phase III CANOVA Study Results; Novartis’ Iptacopan Shows Promise in Phase III Study; Fast Track Designation to AVB-001 for R/R Platinum-Resistant Ovarian Cancer; FDA Issues Complete Response Letter for Lebrikizumab; Nedosiran Approveed for Primary Hyperoxaluria Type 1; Orphan Drug Designation to BDC-1001 for Gastric Cancers
AbbVie Presents Results from Phase III CANOVA Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma AbbVie has released findings from its Phase III CANOVA trial, which assessed the safety and effectiveness of venetoclax (marketed as VENCLEXTA®/VENCLYXTO®) in combination with dexamethasone (known as VenDex) for patients with relapsed or refractory (R/R) multiple myeloma featuring the t(11;14) genetic abnormality. The study did not demonstrate a significant improvement in progression-free survival (PFS), the primary endpoint of the trial. Patients treated with VenDex experienced a median PFS of 9.9 months, compared…
Orthofix Launched the Galaxy Fixation Gemini System; Oxford Biodynamics Launched the EpiSwitch Prostate Screening Blood Test; CE Mark for the Medtronic’s New Simplera CGM; FDA 510(k) Clearance to MicroVention’s SOFIA™ EX 5F 115cm; SHL Telemedicine’s SmartHeart® Technology; Cardiosense’s Nationwide Heart Failure Study
Orthofix Launched the Galaxy Fixation Gemini System and Expanded Sterile Kit Offerings for Orthopedic Trauma Procedures On September 20, 2023, Orthofix Medical Inc., a leading global spine and orthopedics company, launched the Galaxy Fixation Gemini™ system. It is a stable external fixation system that is provided with several sterile procedure kit configurations; as a quick off-the-shelf solution for treating fractures that result from trauma in the lower and upper limbs. The Galaxy Fixation Gemini ankle kit is a pin-to-bar system with specific clamps available in a sterile kit configuration giving…
Challenges in the Pursuit of Alzheimer’s Disease Treatment Breakthroughs: Drug Clinical Trial Failures
Alzheimer’s, the most common type of dementia, particularly with an increasing geriatric population, presents a major global crisis. The disease mostly occurs in sexagenarians, but it may manifest in quadragenarians. It is one of the most prevalent neurodegenerative disorders with a multifactorial pathogenesis. It is characterized by a gradual decline in cognitive and functional abilities, with individuals eventually losing their capability to undertake everyday tasks and function independently. Alzheimer’s disease is one of the top ten leading causes of death in the US and the fifth leading cause of death…