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RxMP Therapeutics Advances Hemostatic Agent RMP-402 with DoD Partnership and FDA Manufacturing Approval

FDA Approval
  • RxMP Therapeutics secured a Cooperative Research and Development Agreement with the Department of Defense's Institute of Surgical Research to validate RMP-402 in large animal models of polytrauma hemorrhage and shock.
  • The company reached consensus with the FDA on its GMP allogeneic manufacturing process for RMP-402, enabling large-scale production of the red cell-derived hemostatic agent.
  • RxMP appointed Shawna Khouri as Chief Operating Officer to oversee operational strategy for its injectable drug platform focused on hemostasis and bleeding management.

World's First HLA-G Targeted Exosome Therapy SOB100 Receives FDA Approval for Phase I Cancer Trials

FDA Approval
  • SOB100, developed by China Medical University Hospital and Shine-On Biomedical, represents the world's first exosome-based drug delivery platform specifically targeting HLA-G for cancer treatment.
  • The FDA approved Phase I clinical trials for SOB100 on March 8, 2025, following promising preclinical results in aggressive cancers including breast cancer and glioblastoma.
  • The platform uses nanobody technology to deliver therapeutic agents across the blood-brain barrier while minimizing systemic toxicity compared to conventional chemotherapy.
  • Shine-On Biomedical has been recognized as one of the top 10 global developers of exosome-based therapies and has established international partnerships for commercial expansion.

Humacyte's Bioengineered Vessel Shows Superior Performance in High-Risk Dialysis Patients

FDA Approval
  • Humacyte's acellular tissue engineered vessel (ATEV) demonstrated superior functional patency compared to standard arteriovenous fistulas in high-risk hemodialysis patients with end-stage kidney disease.
  • The V007 Phase 3 trial enrolled 242 patients, with 110 high-risk individuals defined as females and males with BMI ≥30 kg/m² and diabetes, showing ATEV's better usability and comparable safety profile.
  • Results were presented at the Society for Vascular Surgery meeting, highlighting ATEV's potential to address unmet medical needs in dialysis access for underserved patient populations.
  • The bioengineered vessel required fewer maturation and surgical revision procedures compared to traditional arteriovenous fistulas, despite higher rates of treatable thrombosis and stenosis events.

Mandatory Human Abuse Liability Assessment Reshapes Drug Development Strategy and Regulatory Compliance

FDA Approval
  • The Mandatory Human Abuse Liability Assessment (MAHA) significantly impacts pharmaceutical development timelines and costs by requiring extensive clinical studies to evaluate drug abuse potential.
  • MAHA evaluations involve human clinical trials that measure psychoactive effects and appeal to individuals with substance abuse history, directly influencing FDA scheduling decisions under the Controlled Substances Act.
  • The assessment results critically shape product labeling requirements and marketing strategies, particularly affecting development of abuse-deterrent medications and regulatory compliance approaches.
  • Industry experts emphasize that understanding MAHA nuances is essential for navigating regulatory approval pathways effectively in the current pharmaceutical landscape.

Oncovita Receives FDA Orphan Drug Designation for Oncolytic Measles Virus Therapy in Pleural Mesothelioma

FDA Approval
  • Oncovita's MVdeltaC, a genetically modified measles virus immunotherapy, has received FDA Orphan Drug Designation for treating pleural mesothelioma, a rare and aggressive cancer affecting approximately 3,000 Americans annually.
  • The novel oncolytic virus combines direct tumor cell destruction with immune system activation, representing a promising approach for patients with limited therapeutic options.
  • The designation provides significant regulatory benefits including tax credits, fee waivers, and up to seven years of market exclusivity, positioning Oncovita to enter clinical development by 2026.

Wildtype Becomes First Company to Launch Cultivated Seafood in US Market Following FDA Clearance

FDA Approval
  • Wildtype received FDA "no questions" letter on May 28, 2025, clearing its cell-cultivated salmon as the first cultivated seafood product approved for US consumers.
  • The San Francisco-based company's sushi-grade salmon is now being served at Kann restaurant in Portland, Oregon, marking a watershed moment for the cultivated protein industry.
  • Wildtype's production process grows coho salmon cells in bioreactors without common fish contaminants like mercury, microplastics, and antibiotics found in wild or farmed fish.
  • The approval supports President Trump's April 2025 executive order to boost domestic seafood production and reduce import dependence through innovative technologies.

Redwire Secures Contract with Aspera Biomedicines for Space-Based Cancer Research Using ADAR1 Inhibitor Rebecsinib

FDA Approval
  • Redwire Corporation has secured a contract from Aspera Biomedicines to conduct space-based research on rebecsinib, a small-molecule ADAR1 inhibitor that recently received FDA approval for first-in-human trials.
  • The research will utilize Redwire's PIL-BOX technology to examine the crystal structure of ADAR1p150 protein in microgravity conditions, potentially advancing drug formulation development.
  • Previous spaceflight experiments indicated rebecsinib could serve as a "kill switch" for cancer by stopping cancer stem cell spread in triple-negative breast cancer models.
  • The mission is scheduled for launch in 2025, with rebecsinib representing the first FDA IND-approved small molecule ADAR1 inhibitor with potential applications across 20 different cancer types.

Allergan Botox Patent Infringement Trial Against Revance Set for July in Delaware

FDA Approval
  • A Delaware federal judge has ruled that Allergan's patent infringement lawsuit against Revance Therapeutics will proceed to trial in July 2024, following the denial of summary judgment motions from both parties.
  • The case centers on allegations that Revance's botulinum toxin product Daxxify infringes six Allergan patents related to Botox formulations and stabilization methods.
  • The court dismissed two Allergan entities from the litigation, leaving Allergan Inc. as the sole plaintiff after ruling that Allergan Ireland lacked standing due to insufficient proof of exclusive licensing rights.
  • Revance's Daxxify product received FDA approval for frown lines treatment in 2022 and cervical dystonia in 2023, despite delays caused by COVID-19 pandemic and inspection deficiencies.

ImmunAbs Receives FDA Clearance for Phase 2 Trial of IM-101 Complement Inhibitor in Myasthenia Gravis

Monoclonal AntibodyFDA ApprovalRare Disease
  • ImmunAbs Inc. announced FDA clearance of its IND application to initiate a Phase 2 clinical trial evaluating IM-101, a novel complement C5 inhibitor, for treating Myasthenia Gravis.
  • The multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to assess monthly IM-101 dosing effectiveness and safety.
  • IM-101 demonstrated excellent safety profile in Phase 1 trials with no dose-limiting toxicity and superior efficacy in complement inhibition compared to existing treatments.
  • The company believes comprehensive inhibition of both classical and alternative complement pathways is essential for achieving deeper therapeutic responses in MG patients.

Facet Life Sciences Partners with Nucleus to Advance Radiopharmaceutical Development Through Regulatory Expertise

FDA Approval
  • Facet Life Sciences has announced a strategic partnership with Nucleus, a leader in diagnostic and therapeutic radiopharmaceuticals, to serve as their official regulatory partner for U.S. FDA affairs.
  • Facet's regulatory team brings extensive experience with over 40 FDA applications submitted including INDs, NDAs, BLAs, and ANDAs, plus leadership of more than 75 FDA meetings across multiple divisions.
  • The partnership aims to accelerate radiopharmaceutical product development by providing critical regulatory guidance and ensuring effective navigation of the FDA approval process.
  • Both the FDA and Society of Nuclear Medicine and Molecular Imaging recognize Facet as experts in diagnostic and therapeutic radiopharmaceuticals, positioning them to drive innovation in this specialized field.

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