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Clinical Trial News

Assessing the Clinical Impact of Drug-Drug Interactions: A Focus on Colchicine and COVID-19

  • A recent study in JAMA Network Open evaluated drug-drug interactions (DDIs) involving colchicine in COVID-19 patients, utilizing data from the COLCORONA trial.
  • The analysis found no significant increase in adverse events or hospitalization/death risk due to potential DDIs with colchicine in COVID-19 patients.
  • The study highlights the challenge of translating theoretical DDIs into real-world clinical harms, emphasizing the need for robust screening and testing methods.
  • Conservative prescribing practices and vigilance regarding potential adverse effects remain crucial in managing DDIs, considering over-the-counter medicines and supplements.

AcuraStem Awarded $4 Million CIRM Grant to Advance UNC13A-Targeted Therapy for ALS and FTD

  • AcuraStem receives a $4 million grant from CIRM to support its UNC13A-targeted therapeutic program for ALS and FTD.
  • The funding will advance the development of antisense oligonucleotides (ASOs) designed to restore UNC13A function disrupted by TDP-43 pathology.
  • AcuraStem's iNeuroRx platform facilitates the identification and testing of ASOs to address genetic expression dysfunction in ALS and FTD.
  • The company's previous ASO for the PIKFYVE enzyme was licensed to Takeda Pharmaceuticals and is currently in clinical trials.

FDA Grants Priority Review and Breakthrough Therapy Designation to Imfinzi for SCLC and Approves Neoadjuvant/Adjuvant Use in NSCLC

  • The FDA has granted priority review to Imfinzi for limited-stage small cell lung cancer (SCLC), potentially expediting its availability to patients.
  • Imfinzi also received Breakthrough Therapy designation from the FDA for SCLC, highlighting its potential to significantly improve outcomes.
  • The FDA approved Imfinzi for neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer (NSCLC), expanding its clinical application.
  • These regulatory actions underscore Imfinzi's growing role in treating both SCLC and NSCLC, addressing critical needs in lung cancer therapy.

Pediatric Oncology Nurse Drives Immunotherapy Trials Forward for Relapsed Brain Tumors

  • Robin Dobbins, an oncology research nurse, supports pediatric immunotherapy trials led by Dr. Ted Johnson at Augusta University, focusing on relapsed brain tumors.
  • Dobbins ensures trial protocol adherence, manages tests, dispenses medication, monitors side effects, and reports findings, while providing compassionate support to families.
  • The immunotherapy program leverages ALSF's Travel For Care program to assist families traveling to Augusta, Georgia, for treatment, overcoming accessibility challenges.
  • Dr. Johnson's immunotherapy drug, Indoximod, is currently in Phase 2 trials, with Dobbins hopeful for advancement to Phase 3, bringing it closer to broader availability.

UAB Study Investigates Exercise and Glucose Effects on Heart Hormones in Healthy Adults

  • A cardiometabolic research study at UAB is exploring the impact of exercise and glucose on heart hormones in healthy adults aged 18 and older.
  • The study involves controlled meals, treadmill exercise, glucose tests, and collection of blood, urine, and genetic samples from participants.
  • Participants meeting eligibility criteria, including a BMI under 45 kg/m2 and no history of diabetes, heart, or kidney problems, are being recruited.
  • Qualified participants will receive $300 compensation for completing all study visits, with meals provided at no cost.

Lundbeck Initiates Phase I Trial of Lu AG09222 for Migraine Prevention

  • Lundbeck has commenced a Phase I clinical trial to evaluate Lu AG09222, a second-generation migraine drug, as a potential combination therapy for migraine prevention.
  • The trial aims to assess the safety, tolerability, and pharmacokinetic profile of Lu AG09222 when administered in combination with other migraine treatments.
  • Lu AG09222 represents Lundbeck's "most promising" candidate for migraine, reflecting the company's commitment to addressing this debilitating neurological condition.

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

NCT06578585RecruitingPhase 1
H. Lundbeck A/S
Posted 9/13/2024

Precision Medicine and Clinical Trials Improve Breast Cancer Survivorship

  • Breast cancer treatment has evolved, with precision medicine tailoring therapies to specific cancer types, improving survival rates.
  • Clinical trials, like the one at KU Cancer Center, play a crucial role in advancing treatment options for aggressive cancers such as HER2-positive breast cancer.
  • Early detection and innovative drugs have significantly contributed to increased survivorship and reduced disease stage at diagnosis.
  • Research now focuses on prevention strategies to stop precancerous cells from developing into cancer, further improving patient outcomes.

FDA Advisors Question Novel Oral Antibiotic Sulopenem for UTI Treatment

  • FDA advisory committee members voiced concerns regarding the potential for antimicrobial resistance and misuse of sulopenem, a novel oral antibiotic for uncomplicated urinary tract infections (uUTIs).
  • Advisors emphasized the need for restricted use in patients with resistant organisms or those who have failed first-line therapies to mitigate the risk of off-label use and resistance amplification.
  • Clinical trial data showed sulopenem was non-inferior to amoxicillin/clavulanate in patients susceptible to the latter, but the sample size was insufficient to draw conclusions for resistant infections.
  • The FDA will consider the committee's discussion to decide on sulopenem's approval by October 25, with potential modifications to labeling to ensure appropriate use.

Autolus' Obe-cel Nears Potential FDA Approval for Adult B-cell ALL

  • Autolus Therapeutics anticipates a November 16, 2024 PDUFA date for obe-cel, a CAR-T cell therapy targeting relapsed/refractory adult B-cell acute lymphoblastic leukemia (B-ALL).
  • Phase 1b/2 FELIX study data showed a 78% overall response rate (CR/CRi) in patients treated with obe-cel, with a median overall survival of 23.8 months.
  • Obe-cel may offer advantages over existing therapies like Tecartus, potentially demonstrating a more favorable safety profile with lower rates of cytokine release syndrome and ICANS.
  • Autolus has a strong cash position and partnerships with BioNTech, Moderna, and Bristol Myers Squibb, supporting the potential commercial launch and further development of obe-cel.

Elutia Celebrates First Anniversary Marked by EluPro FDA Approval and Commercial Launch

  • Elutia Inc. celebrates its first anniversary following a strategic shift towards drug-eluting biologics, marked by rebranding and a new mission.
  • The company secured FDA approval for EluPro, the first Antibiotic-Eluting BioEnvelope, and successfully completed an FDA inspection of its manufacturing facility.
  • Elutia achieved significant milestones, including the first implantation of EluPro and a 20% growth in proprietary product sales.
  • Elutia's stock value increased by over 170% in its first year, reflecting strong performance and increased shareholder value.

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