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Adalimumab Biosimilar Shows Similar Patient-Reported Outcomes to Humira in Rheumatoid Arthritis Trial

  • The VOLTAIRE-RA trial demonstrated similar efficacy and safety between the adalimumab biosimilar Cyltezo and the reference product Humira in patients with moderate to severe rheumatoid arthritis.
  • Patient-reported outcomes (PROs) showed comparable improvements in symptom reduction and side effects for participants receiving the biosimilar versus those receiving Humira.
  • Both treatment groups experienced clinically meaningful improvements in physical and mental health components, with no significant differences observed at 12 and 24 weeks.
  • A high proportion of participants reported greater improvements compared to a reference US population, indicating the attainment of a significant treatment goal.

FDA Approves Bristol Myers Squibb's Cobenfy for Schizophrenia Treatment

  • The FDA has approved Cobenfy, a new drug developed by Bristol Myers Squibb, for the treatment of schizophrenia, representing a significant advancement in the field..
  • Cobenfy distinguishes itself from other schizophrenia treatments by not carrying the typical mortality warning for elderly patients, potentially offering a safer option for this demographic.
  • The approval comes at a crucial time, addressing a long-standing need for innovative therapies in schizophrenia management after decades of limited progress.

Talquetamab Treatment Shows Low Incidence of Neurological Adverse Events in Multiple Myeloma Patients

  • Talquetamab, a bispecific antibody, has shown potential neurological effects, but instances are infrequent, according to a nurse practitioner at UCSF.
  • The MonumenTAL-1 study reported neurotoxicity in 10% and 5% of patients receiving 405 mcg and 800 mcg doses of talquetamab, respectively, with most cases being low grade and resolving.
  • Immune effector cell-associated neurotoxicity syndrome occurred in 10.7% and 11% of patients receiving talquetamab at 0.4 mg/kg and 0.8 mg/kg, respectively, in the phase 2 portion of the trial.
  • Standard monitoring, including Immune Effector Cell Encephalopathy (ICE) scores every 12 hours, helps in closely observing and managing potential neurological effects in patients.

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

Low-Dose LSD Shows Promise in Treating Canine Anxiety Without Side Effects

  • A recent study explored the use of low-dose 1cp-LSD to treat anxiety in dogs, particularly separation anxiety, offering a potential alternative to traditional medications.
  • The study focused on a 13-year-old dog named Lola, who exhibited significant calming effects and reduced anxiety symptoms after 1cp-LSD administration.
  • Notably, the treatment showed no apparent side effects or alterations in the dog's mental state, suggesting a safer profile compared to existing treatments.
  • This research highlights the potential for psychedelic drugs, specifically low-dose LSD, in veterinary medicine for managing anxiety in dogs, addressing a significant unmet need.

TH17 Cells Identified as Potential Biomarker for Immune-Related Adverse Events in Metastatic Melanoma

  • TH17 cells may serve as a predictive biomarker for immune-related adverse events (irAEs) in metastatic melanoma patients treated with nivolumab, ipilimumab, and tocilizumab.
  • High levels of IL-6 and osteopontin in classical monocytes correlate with shorter overall survival in metastatic melanoma patients undergoing immunotherapy.
  • Blocking IL-6 with tocilizumab preserved progression-free survival and overall survival while reducing irAEs in combination with ipilimumab and nivolumab.
  • A phase 2 trial's success has spurred a follow-up study (S22-00325) evaluating sarilumab, another IL-6 receptor blocker, in combination with immuno-oncology triplet therapy.

A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

NCT02714218CompletedPhase 3
Bristol-Myers Squibb
Posted 4/4/2016

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

NCT01844505CompletedPhase 3
Bristol-Myers Squibb
Posted 6/11/2013

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

NCT05428007RecruitingPhase 2
NYU Langone Health
Posted 12/16/2022

A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

NCT03999749Active, Not RecruitingPhase 2
NYU Langone Health
Posted 6/11/2019

Sedentary Behavior Reduction Fails to Lower Blood Pressure in Desk Workers

• A 3-month intervention reduced sedentary time by one hour daily among desk workers but did not significantly lower blood pressure. • The RESET-BP study included 271 participants with elevated blood pressure who were not on antihypertensive medications. • Reducing sedentary behavior was associated with decreased diastolic BP, while increased standing during work was linked to increased arterial stiffness. • Researchers suggest further studies are needed to explore different populations and strategies for reducing sedentary behavior.

Low-Frequency Ventilation During Cardiac Surgery Protects Lung Function

  • A clinical trial led by the University of Bristol found that low-frequency ventilation (LFV) during heart valve surgery may protect lung function.
  • The study demonstrated the feasibility and safety of LFV during heart-lung machine use in patients undergoing heart valve surgery.
  • Patients receiving LFV showed preserved lung function and improved walking distance compared to those with standard collapsed-lung practice.
  • LFV also triggered a change in the sRAGE biomarker, potentially paving the way for future lung protection drug development.

Estrogen's Role in Tumor Growth and Immune Suppression Unveiled, Offering New Therapeutic Avenues

  • Estrogen has been found to promote tumor growth in estrogen receptor-negative breast cancers and other cancers like melanoma and colon cancer by suppressing the immune system.
  • Anti-estrogen drugs can reverse the negative effects of estrogen, restoring the immune system's ability to fight tumors and enhancing the effectiveness of immunotherapies.
  • A clinical trial is planned to evaluate the anti-estrogen drug lasofoxifene in patients with triple-negative breast cancer to improve immunotherapy outcomes.
  • This research highlights the potential of combining estrogen receptor modulators with immune checkpoint blockades to treat various cancers where tumor-associated tissue eosinophilia is beneficial.

Zydus Lifesciences Gains USFDA Approval for Enzalutamide Formulations

  • Zydus Lifesciences has received USFDA approval for Enzalutamide capsules (40 mg) for metastatic castration-resistant prostate cancer.
  • The company also received tentative approval for Enzalutamide tablets (40 mg and 80 mg) for castration-resistant and metastatic castration-sensitive prostate cancer.
  • These approvals mark Zydus's 400th approval, with over 465 ANDAs filed since FY 2003-04, strengthening its oncology portfolio.
  • The approved drugs will be manufactured at Zydus's facilities in Moraiya and SEZ, Ahmedabad, with significant market potential in the US.

Naveris Showcases NavDx Test Advances for HPV-Associated Oropharyngeal Cancer Surveillance at ASTRO 2024

  • Naveris will present new data at the ASTRO Annual Meeting demonstrating the NavDx test's role in managing HPV-driven oropharyngeal cancers.
  • A study analyzing over 1,000 blood samples showed NavDx can identify patients at risk of treatment failure earlier than imaging.
  • Research indicates NavDx can predict outcomes based on HPV DNA clearance during treatment, potentially guiding radiation therapy intensity.
  • Data suggests NavDx outperforms imaging in post-radiotherapy surveillance for oropharyngeal cancer, exhibiting fewer false positives.

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