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Celltrion's Ustekinumab Biosimilar SteQeyma Approved in Europe; Zymfentra Access Expands

  • The European Commission approved Celltrion's SteQeyma, an ustekinumab biosimilar referencing Stelara, for treating chronic inflammatory diseases across gastroenterology, dermatology, and rheumatology.
  • Celltrion USA partnered with Cigna Healthcare and Express Scripts to broaden patient access to Zymfentra (infliximab-dyyb) for ulcerative colitis and Crohn's disease.
  • MedImpact Healthcare Systems is expanding access to biosimilars referencing Humira (adalimumab), including Simlandi, for patients with Crohn's disease and rheumatoid arthritis.
  • The Association for Accessible Medicines held a policy briefing addressing patent-related barriers hindering patient access to biosimilars and generic medicines.

Eyenovia Launches Clobetasol Propionate Ophthalmic Suspension for Post-Ocular Surgery Inflammation and Pain

  • Eyenovia has commercially launched clobetasol propionate ophthalmic suspension 0.05% in the U.S. for treating post-operative inflammation and pain after eye surgery.
  • Clobetasol, a potent steroid, offers a convenient twice-daily dosing regimen, distinguishing it from many other post-surgical eye drops.
  • Phase 3 study results presented at AAO 2024 demonstrated rapid inflammation and pain relief with clobetasol compared to placebo, along with improved visual acuity.
  • Market research indicates strong interest from ophthalmic surgeons in prescribing clobetasol due to its efficacy, safety profile, and simplified distribution model.

PolarCool Submits FDA De Novo Application for PolarCap System to Treat Concussions

  • PolarCool has submitted a De Novo application to the FDA for its PolarCap System, aiming for market approval in the U.S.
  • The U.S. market for concussion treatment is valued at approximately SEK 3.4 billion annually, presenting a significant opportunity for PolarCool.
  • Clinical results from a 5-year study support the De Novo application, positioning PolarCap as a novel treatment for concussions.
  • PolarCool anticipates a full-scale investment in the U.S. market in 2025-2026, with an employee already stationed in the U.S. to prepare for the launch.

GAO Report Highlights Incomplete Reporting in DOD and VA Biomedical Research

  • A recent GAO report reveals that the Departments of Defense (DOD) and Veterans Affairs (VA) dedicated approximately $20 billion and $10 billion, respectively, to biomedical R&D from 2019 to 2023.
  • The study found inconsistencies in disclosing DOD support in biomedical patents, with 559 out of 3,078 patents lacking correct DOD award numbers.
  • The GAO report indicates that the majority of DOD- and VA-funded clinical trials registered between 2014 and 2023 had late or missing results, hindering transparency and access to crucial scientific information.

New HER2 Test Could Expand Trastuzumab Deruxtecan Eligibility for Lung Cancer Patients

  • A novel, more sensitive test for HER2 protein in lung cancer tissues has been developed, potentially expanding the number of patients eligible for trastuzumab deruxtecan (T-DXd).
  • The new assay detected elevated HER2 levels in 63% of lung cancer samples, a significant increase compared to the 2% identified by current standard tests.
  • This advancement could lead to more personalized treatment approaches, matching patients with targeted therapies based on their unique biomarker profiles.
  • Researchers are working on similar tests for other cancer types, paving the way for broader application of biomarker-driven cancer treatments.

Intrathecal Pain Pump Significantly Improves Quality of Life for Pancreatic Cancer Patients

  • An intrathecal pain pump delivers medication directly to the spinal cord, offering potent pain relief with lower doses compared to oral medications for pancreatic cancer patients.
  • A patient at MD Anderson Cancer Center experienced significant improvements in quality of life, including increased activity levels and reduced pain, after receiving an intrathecal pain pump.
  • The pain pump delivers non-opioid medication, addressing both tumor pain and neuropathy, allowing the patient to engage in daily activities and enjoy a fuller life.
  • This treatment option is particularly beneficial for patients with constant cancer pain who seek an improved quality of life, warranting a discussion with their healthcare provider.

Self-Swab HPV Tests Offer Less Invasive Cervical Cancer Screening Alternative

  • FDA has approved self-collection HPV tests, offering a less invasive alternative to traditional Pap smears for cervical cancer screening.
  • Self-swabbing involves patients collecting vaginal samples in healthcare settings, shown to be as effective as doctor-collected cervical samples.
  • The new option aims to increase screening rates by addressing discomfort and accessibility issues associated with speculum-based exams.
  • Regular cervical cancer screening, including HPV tests, is crucial for early detection and reduced mortality, with guidelines recommending primary HPV testing every five years for adults aged 25-65.

Axonics R20 Sacral Neuromodulation System Gains Australian Regulatory Approval

  • Axonics has secured regulatory approval in Australia for its R20 rechargeable sacral neuromodulation (SNM) system, designed for treating overactive bladder and fecal incontinence.
  • The R20 system, similar in size to its predecessor, boasts a 20-year functional life and requires charging only every 6-10 months for one hour.
  • Following FDA approval in January 2023 and CE mark in March 2024, Axonics plans to launch R20 sales in Australia by November.
  • This approval expands Axonics' presence in Australia, where it already markets its F15 recharge-free SNM system and Bulkamid hydrogel.

Moderna Faces Scrutiny Over Incentives in Pediatric COVID-19 Vaccine Trial

  • Moderna is under scrutiny after a UK NHS pediatrician offered children £1,500 to participate in the Phase III NextCOVE COVID-19 vaccine trial.
  • The Prescription Medicines Code of Practice Authority (PMCPA) found Moderna in breach of conduct for failing to maintain high standards.
  • The incentive contravened clinical trial regulations prohibiting financial inducements to children, potentially undermining informed consent.
  • Moderna stated that the amount was from a draft document and that participants only received compensation for travel expenses.

A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19

NCT05815498CompletedPhase 3
ModernaTX, Inc.
Posted 3/28/2023

NIH's RECOVER Initiative Shifts Focus to Clinical Trials for Long COVID Treatments

  • The NIH's RECOVER initiative is transitioning to RECOVER-TLC, prioritizing clinical trials for long COVID treatments, addressing the lack of approved therapies.
  • RECOVER-TLC will invite drugmakers and researchers to submit potential treatments, with a focus on timely evaluation and response to accelerate the development process.
  • A key challenge for RECOVER-TLC will be defining trial endpoints due to the diverse presentation of long COVID, impacting multiple systems and overlapping with other conditions.
  • The success of RECOVER-TLC is critical for long COVID patients, emphasizing the urgent need to translate research into actionable treatments.

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