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Clinical Trial News

Strategic Collaborations and Novel Therapies Advance Cancer and Brain Injury Treatment

• AstraZeneca and Moffitt Cancer Center are collaborating to accelerate cell therapy development, focusing on CAR T and TCR T therapies for solid tumors. • SWOG Cancer Research Network developed a risk prediction model to identify cancer patients at high risk for emergency room visits during clinical trials. • A national clinical trial is launched by UC San Francisco to repurpose existing drugs for treating traumatic brain injury (TBI), addressing a critical unmet need. • The Ohio State University initiates clinical trials for HOSU-53, a novel DHODH inhibitor, in partnership with Jabez Biosciences, targeting cancer metabolism.

NABP Prepares Pharmacies for Critical DSCSA Compliance Deadline in November 2024

  • The Drug Supply Chain Security Act requires prescription drugs to be serialized with 2D barcodes at the unit level, enabling tracking and authentication to prevent counterfeit medications from entering the supply chain.
  • Small dispensers have received a limited exemption until November 2024, but must still comply with core requirements including authorized trading partner verification and suspect product quarantine procedures.
  • NABP's Pulse platform is being deployed to help pharmacies maintain compliance by providing tools for trading partner verification, product investigation, and uniform regulatory response management.

Toripalimab Approved in India, Hong Kong, and Europe for Nasopharyngeal and Esophageal Cancers

  • Toripalimab gains approval in India and Hong Kong for recurrent or metastatic nasopharyngeal carcinoma (NPC) as both a first-line combination therapy and a single-agent treatment.
  • The European Commission approves toripalimab in combination with chemotherapy for first-line treatment of recurrent or metastatic NPC and esophageal squamous cell carcinoma (ESCC).
  • Approvals are based on Phase 3 JUPITER-02 and JUPITER-06 trials, demonstrating significant improvements in progression-free and overall survival compared to chemotherapy alone.
  • Toripalimab, developed by Junshi Biosciences, is now approved in over 30 countries and regions, marking a significant expansion of its global commercial strategy.

The Study to Evaluate Toripalimab (JS001) in Patients With Advanced GC, ESCC, NPC, HNSCC

NCT02915432Unknown StatusPhase 1
Shanghai Junshi Bioscience Co., Ltd.
Posted 12/1/2016

Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma

NCT03829969CompletedPhase 3
Shanghai Junshi Bioscience Co., Ltd.
Posted 1/31/2019

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

NCT03581786CompletedPhase 3
Shanghai Junshi Bioscience Co., Ltd.
Posted 10/18/2018

Pfizer Withdraws Sickle Cell Disease Drug Oxbryta Worldwide Due to Safety Concerns

  • Pfizer is voluntarily withdrawing all lots of Oxbryta (voxelotor) from global markets due to an unfavorable risk-benefit profile for sickle cell disease patients.
  • Clinical data indicated a potential imbalance in vaso-occlusive crises and fatal events, prompting further investigation and consultation with regulatory authorities.
  • Patients are advised to contact their physicians to discuss alternative treatments for sickle cell disease, as Pfizer discontinues distribution and clinical studies of Oxbryta.
  • The company does not anticipate this withdrawal will impact its full-year 2024 financial guidance.

SPRIM PRO Validates At-Home Infant Growth Monitoring for Clinical Trials

  • SPRIM PRO's study validates at-home infant growth measurements by caregivers, enhancing clinical trial accessibility and diversity.
  • The decentralized approach reduces the burden on caregivers and clinical sites, minimizing exposure risks for healthy newborns.
  • The methodology supports faster, safer infant formula development, aligning with increased FDA regulations and formula shortages.
  • Standardized training ensures caregivers accurately collect anthropometric data, comparable to healthcare professionals.

Spine BioPharma Completes Enrollment in Phase 3 Trial of SB-01 for Chronic Low Back Pain

  • Spine BioPharma completed enrollment in its Phase 3 MODEL trial, evaluating SB-01 for chronic low back pain (CLBP) due to degenerative disc disease (DDD).
  • The trial enrolled 417 subjects across 30 sites in the U.S. to assess the safety and efficacy of SB-01 in adults with CLBP and related functional impairments.
  • SB-01 is a synthetic peptide that modulates TGF-Beta activity, offering a potential non-surgical treatment option for DDD-related pain.
  • The completion of enrollment marks a significant step toward addressing the unmet needs of millions suffering from CLBP associated with DDD.

Amgen's Rocatinlimab and Uplizna Phase 3 Data Impact Stock

  • Amgen's stock experienced a 3% dip following the release of Phase 3 trial data for rocatinlimab and Uplizna, impacting investor confidence.
  • The MITIGATE Phase 3 trial assessed the efficacy and safety profiles of rocatinlimab and Uplizna, providing critical insights into their clinical applications.
  • Detailed findings from the Phase 3 trials were presented online, offering a comprehensive overview of the drugs' performance and potential benefits.

FDA Cracks Down on Counterfeit Ozempic and Mounjaro as Illegal Compounding Surges

  • FDA reports nearly 400 adverse reactions to compounded versions of semaglutide and tirzepatide between 2021-2024, with some cases requiring hospitalization.
  • Novo Nordisk has filed 34 legal actions against compounders of unauthorized semaglutide products, while Eli Lilly discovers counterfeit tirzepatide containing bacterial contamination and incorrect ingredients.
  • Australia implements complete ban on compounded diabetes and weight loss medicines following serious adverse events, highlighting global safety concerns around unauthorized GLP-1 medications.

Epineuron's PeriPulse System Receives Health Canada Approval for Nerve Regeneration

  • Epineuron has received Health Canada approval for its PeriPulse™ system, designed to enhance nerve regeneration in patients with severe nerve injuries and chronic neurological conditions.
  • The PeriPulse™ system features an advanced shapeable electrode and a patient-wearable component, facilitating quick deployment and electrical stimulation therapy in the recovery room.
  • Clinical data supporting the approval comes from a multi-center first-in-human trial, with further data expected from ongoing REGAIN™ and SELECT™ trials focused on nerve lacerations and compression injuries.
  • With this regulatory clearance, Epineuron is scaling up manufacturing, sales, and marketing efforts to support the commercialization of the PeriPulse™ system.

Enalare Therapeutics Receives FDA Clearance for Phase 1 Study of ENA-001 in the US

  • Enalare Therapeutics received FDA clearance to begin a Phase 1 clinical trial of ENA-001 in the United States, targeting respiratory depression associated with drug overdose.
  • The Phase 1 study will evaluate both intramuscular (IM) and intravenous (IV) formulations of ENA-001, building on five previous successful Phase 1 studies in Europe using the IV formulation.
  • ENA-001's novel mechanism of action as an agnostic respiratory stimulant, inhibiting Big Potassium (BK) ion channels, offers a potential treatment for various life-threatening conditions.
  • The development of ENA-001 is supported by funding from BARDA and NIDA, highlighting its potential as a medical countermeasure in mass-casualty events and for treating drug overdose.

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