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Clinical Trial News

Curiteva Receives FDA 510(k) Clearance for First 3D-Printed PEEK Standalone Spinal Implant

  • Curiteva secured FDA 510(k) clearance for the Inspire Trabecular PEEK Standalone ALIF system, marking the first-ever 3D printed PEEK standalone implant with HAFUSE technology.
  • The implant features fully integrated porosity, exceptional radiographic visibility, and optimal biomechanical properties engineered to promote osseointegration across the entire construct.
  • Dr. Stephen Tolhurst from Texas Back Institute reported striking results over two years of use, with visual confirmation of bone growth both on and through the implant.
  • The rapid regulatory approval was facilitated by Curiteva's proprietary FDA Master File for Inspire technology, building on previous success with the Inspire Lumbar Interbody clearance.

Breckenridge Pharmaceutical Receives FDA Approval for Generic Dehydrated Alcohol Injection for Hypertrophic Obstructive Cardiomyopathy

Drug ApprovalRare Disease
  • Breckenridge Pharmaceutical received FDA approval for its generic version of Ablysinol, a dehydrated alcohol injection used to treat symptomatic hypertrophic obstructive cardiomyopathy in patients unsuitable for surgical myectomy.
  • The sterile, preservative-free solution contains ≥99% ethyl alcohol and is indicated for inducing controlled cardiac septal infarction to improve exercise capacity in adult HOCM patients.
  • This approval positions Breckenridge as one of the first companies to offer a generic alternative to Ablysinol in the U.S. market, supporting the company's strategy to expand its institutional healthcare presence.
  • The product will be available primarily in hospitals, clinics, and home health care facilities, reflecting Breckenridge's commitment to providing affordable treatment options for rare disease patients.

Duvelisib-Romidepsin Combination Shows 61% Response Rate in Relapsed T-Cell Lymphomas

Real World Evidence
  • A real-world study by Mass General Brigham's PETAL Consortium demonstrated that the combination of duvelisib and romidepsin achieved a 61% overall response rate in 38 patients with relapsed/refractory T-cell lymphomas.
  • The treatment enabled 11 patients to proceed to stem cell transplantation, with 47% achieving complete response and no detectable cancer.
  • Patients with nodal T-follicular helper cell subtype showed particularly strong results with an 82% response rate to the combination therapy.
  • Despite manageable side effects and the need for dose modifications, the study provides evidence for this novel therapeutic strategy in aggressive blood cancers that resist standard treatment.

ForSight Robotics Raises $125M Series B to Advance ORYOM Robotic Eye Surgery Platform

AI
  • ForSight Robotics completed a $125M Series B funding round led by Eclipse to accelerate development of the ORYOM Platform, the world's first robotic surgery system for cataract and other eye diseases.
  • The company plans to launch first-in-human clinical trials this year, addressing a global crisis where over 600 million patients suffer from cataracts but only 30 million receive surgical treatment annually.
  • The ORYOM Platform utilizes AI-based algorithms, advanced computer vision, and micromechanics to provide unprecedented precision for ophthalmic procedures, with capability to access both anterior and posterior eye segments.
  • The funding brings ForSight Robotics' total funding to $195M as the company doubles in size to over 110 employees and prepares to tackle the projected 12% decline in ophthalmologists by 2035.

Abridge Secures $300M Series E Funding, Reaches $5.3B Valuation for AI Clinical Documentation Platform

AI
  • Abridge raised $300 million in Series E funding led by Andreessen Horowitz, bringing its valuation to $5.3 billion for its ambient listening technology that automates clinical documentation.
  • The AI-powered platform serves over 150 health systems including Kaiser Permanente, UPMC, and Sutter Health, generating clinical notes from medical conversations across 55 specialties and 28 languages.
  • The company reports significant clinical impact with 60-70% reduction in burnout and over 90% clinician retention rate, while projecting support for more than 50 million medical conversations in 2025.
  • This funding round follows a $250 million raise in February, representing one of the most substantial health tech deals of 2024 as AI scribes gain rapid adoption to address clinician burnout.

Inventprise's Novel COVID-19 Conjugate Vaccine Shows Broad Protection Against Multiple Variants in Preclinical Study

  • Inventprise published preclinical data in Vaccine Journal demonstrating its bivalent SARS-CoV-2 conjugate vaccine elicited broad neutralizing antibody responses across up to five COVID-19 variants.
  • The 18-month study showed the vaccine stimulated both B-cell and T-cell immunity, including memory T-cell formation, potentially offering longer-lasting protection than current mRNA vaccines.
  • The conjugate platform uses a detoxified diphtheria-derived carrier protein conjugated to SARS-CoV-2 Beta and Delta strain surface proteins expressed in CHO cells.
  • The technology could address cold-chain requirements and booster logistics challenges, particularly benefiting global health equity in resource-limited settings.

Xenon Pharmaceuticals Appoints Darren Cline as Chief Commercial Officer Ahead of Azetukalner Phase 3 Data

  • Xenon Pharmaceuticals has appointed Darren Cline as Chief Commercial Officer to lead commercial strategy for azetukalner, the company's lead Phase 3 candidate targeting epilepsy, major depressive disorder, and bipolar depression.
  • Cline brings over 30 years of biopharmaceutical commercial experience, including successful launches of Epidiolex at GW Pharmaceuticals and Adcetris at Seagen.
  • The appointment comes as Xenon prepares for Phase 3 azetukalner data expected in early 2026, positioning the company for its first potential commercial launch in epilepsy.
  • Azetukalner is a novel Kv7 potassium channel opener currently in Phase 3 trials for epilepsy and major depressive disorder, with a Phase 3 trial in bipolar depression planned for 2025.

Biocon Biologics Partners with Malaysia's National Cancer Society to Launch Biosimilar Access Program

OncologyMonoclonal Antibody
  • Biocon Biologics has partnered with the National Cancer Society of Malaysia to launch a Patient Assistance Programme providing affordable oncology biosimilars to underserved cancer patients.
  • The program will initially focus on providing trastuzumab to patients facing treatment delays due to financial constraints, with plans to expand to pegfilgrastim and bevacizumab.
  • This collaboration builds on Biocon's previous success in Malaysia's diabetes care, where the company has served over 345,000 patients through affordable treatment programs.
  • The partnership combines Biocon's biosimilar expertise with NCSM's community outreach capabilities to enhance cancer care accessibility in Malaysia.

Starton Therapeutics Partners with Bend Bioscience to Develop Oral Sustained-Release Lenalidomide for Multiple Myeloma

  • Starton Therapeutics has entered a collaboration agreement with Bend Bioscience to develop STAR-LLD, an oral sustained-release formulation of lenalidomide designed to improve tolerability and efficacy in multiple myeloma treatment.
  • Preclinical studies demonstrated that STAR-LLD achieved 100% overall response rate with continuous delivery compared to 0% with standard daily dosing, while also showing 80% tumor shrinkage over 28 days.
  • A Phase 1b clinical study in six relapsed/refractory multiple myeloma patients showed all participants achieved objective responses with no grade >2 drug-related hematologic toxicity through 12 treatment cycles.
  • The partnership leverages Bend's controlled release formulation expertise to optimize STAR-LLD's performance and scalability for potential commercial manufacturing.

NCT/UCC Dresden Launches Phase 2 Trial of Personalized mRNA Vaccine for Pancreatic Cancer

  • NCT/UCC Dresden becomes the only site in Saxony to offer patients access to BioNTech and Genentech's personalized mRNA vaccine Autogene Cevumeran for pancreatic cancer treatment.
  • The Phase 2 IMCODE003 study combines the mRNA vaccine with checkpoint inhibitor Atezolizumab and chemotherapy to reduce recurrence risk in post-surgical pancreatic cancer patients.
  • Previous Phase 1 results showed that half of patients treated with Autogene Cevumeran developed strong T-cell immune responses and experienced significantly reduced relapse risk.
  • The trial addresses the urgent need for new treatments in pancreatic cancer, where only one in three to four patients survives five years despite surgery and chemotherapy.

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

NCT05968326RecruitingPhase 2
Genentech, Inc.
Posted 10/18/2023

Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery

NCT04161755Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 12/13/2019

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