Clinical Trial News
FDA Issues Warning About Severe Itching After Discontinuing Common Allergy Medications
• The FDA has announced it will add warnings about rare but severe pruritus risk following discontinuation of long-term cetirizine or levocetirizine use to prescription and OTC labels.
• The agency identified 209 global cases of severe itching after stopping these antihistamines, with symptoms typically occurring within days of discontinuation after months or years of daily use.
• Healthcare professionals are advised to discuss this risk with patients before prescribing these medications, noting that restarting the medication may improve symptoms.
FDA Advisory Committee Rejects Genentech's Columvi Expansion for Transplant-Ineligible DLBCL Patients
• The FDA's Oncologic Drugs Advisory Committee voted 8-1 against expanding Genentech's bispecific antibody Columvi for transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
• Committee members expressed concerns about the applicability of the Phase III STARGLO study data to the U.S. population, as half of the participants were Asian patients with only 25 enrolled from North America.
• Columvi, which targets CD20 and CD3 proteins, was initially approved in June 2023 for DLBCL patients who had undergone at least two prior lines of systemic therapy.
Spider Venom-Derived Peptide Shows Promise in Post-Prostatectomy Erectile Dysfunction Phase II Trial
• Another Day Pharma's BZ371A, a synthetic peptide derived from spider venom, demonstrated significant efficacy in treating erectile dysfunction following prostate cancer surgery in a Phase II trial of 74 men.
• The topical gel treatment showed superior results compared to standard tadalafil therapy, with combination therapy achieving a 38% success rate versus 4% for tadalafil alone (p<0.05).
• BZ371A works through a novel mechanism that stimulates nitric oxide production, making it particularly valuable for men with compromised neural pathways after prostatectomy.
Highlighted Clinical Trials:
Biozeus Biopharmaceutical S.A.
Posted 11/22/2023
BRAIN Biotech Expands European Footprint with Full Acquisition of Breatec and New Production Facility
• BRAIN Biotech AG has completed the acquisition of remaining minority shares in Dutch subsidiary Breatec B.V., consolidating full ownership of all businesses in its BRAINBiocatalysts division.
• The company has signed a lease for a new enlarged production site near Den Bosch, Netherlands, which will serve as an integrated continental European production and warehousing hub with expanded enzyme-based baking applications capabilities.
• As part of operational restructuring, BRAIN Biotech will close its Büttelborn, Germany facility and transfer production operations to the new Dutch site, with beverage enzyme operations moving to the company's R&D campus in Zwingenberg.
Spain Dramatically Reduces Timeframe Between EU Drug Approval and Reimbursement Decisions
• Spain has significantly shortened the waiting period between European drug authorization and national financing decisions, improving patient access to new medications.
• Spanish health authorities emphasize that pharmaceutical companies can further accelerate the reimbursement process by submitting more comprehensive and well-prepared applications.
• The streamlined approval pathway represents Spain's commitment to modernizing its healthcare system while balancing innovation access with fiscal sustainability.
Glofitamab-GemOx Shows Survival Benefit in Phase 3 STARGLO Trial for R/R DLBCL, But FDA Advisory Committee Questions US Applicability
• The phase 3 STARGLO trial demonstrated that glofitamab combined with gemcitabine and oxaliplatin nearly doubled median overall survival to 25.5 months compared with 12.9 months for rituximab-GemOx in transplant-ineligible R/R DLBCL patients.
• Despite showing a 41% reduction in death risk and 63% reduction in disease progression, the FDA's Oncologic Drugs Advisory Committee voted 8-to-1 against the applicability of the trial data to US patients, citing regional outcome differences.
• Glofitamab, a CD20xCD3 bispecific antibody, is currently approved in over 30 countries and has accelerated approval in the US, with an FDA decision on full approval expected by July 20, 2025.
Highlighted Clinical Trials:
Hoffmann-La Roche
Posted 2/23/2021
Hoffmann-La Roche
Posted 2/21/2017
FDA Approves Hyalex Orthopaedics' IDE Supplement for Pivotal Trial of Freestyle Knee Implant
• The FDA has approved Hyalex Orthopaedics' supplemental IDE application, allowing expansion of their Early Feasibility Study into a pivotal clinical trial for the Freestyle Knee Implant.
• The novel implant technology targets patients with cartilage damage and early osteoarthritis of the femoral condyle, addressing an estimated $2 billion market in the US with limited current treatment options.
• Early clinical evaluations have shown promising results in mimicking natural joint mechanics and helping patients return to active lifestyles, according to principal investigator Dr. Sabrina Strickland.
Highlighted Clinical Trials:
Hyalex Orthopaedics, Inc.
Posted 4/4/2024
Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment
• Tempus AI and Verastem Oncology have announced a collaboration to develop a companion diagnostic test for the recently FDA-approved combination therapy of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer.
• The partnership builds on Tempus' confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, with their FDA-approved xT CDx assay now being used as an investigational assay in the global Phase 3 RAMP-301 trial.
• Low-grade serous ovarian cancer (LGSOC) is a rare form affecting younger women, accounting for 6-10% of serous ovarian cancers, with historically poor response to chemotherapy and limited treatment options.
CellProthera Partners with CELLforCURE by SEQENS for Phase 3 Manufacturing of Heart Attack Cell Therapy
• CellProthera has selected CELLforCURE by SEQENS as its CDMO partner for Phase 3 manufacturing of ProtheraCytes, an autologous expanded CD34+ stem cell therapy for severe heart attack patients.
• The partnership will begin with technology transfer in 2025, with clinical batch production expected to start in 2026 following favorable FDA feedback on the Phase 3 trial design.
• ProtheraCytes aims to improve heart failure event-free survival following severe heart attacks and has shown promising results in Phase 1/2b studies as it advances toward market authorization.
Aging Impairs CAR-T Cell Therapy Effectiveness Through Metabolic Decline, Swiss Study Reveals
• New research from Swiss institutions demonstrates that age-related immune decline significantly reduces the effectiveness of CAR-T cell cancer therapy by impairing mitochondrial function and metabolism.
• Scientists identified decreased levels of nicotinamide adenine dinucleotide (NAD) as the key factor behind reduced antitumor activity in CAR-T cells from older individuals.
• Researchers successfully rejuvenated aged CAR-T cells by restoring NAD levels in preclinical models, suggesting potential strategies to improve immunotherapy outcomes in older cancer patients.