A post-hoc analysis of the CHAMPION-MG trial reveals that over 80% of gMG patients experienced meaningful symptom reduction after six months of Ultomiris treatment.

Intellia Therapeutics' NTLA-2002 met all primary and secondary endpoints in Phase II trials, demonstrating potential efficacy and safety for hereditary angioedema (HAE).

KIND's AND017 Phase 2 trial results for anemia in dialysis-dependent chronic kidney disease (DD-CKD) will be presented at ASN Kidney Week 2024.

• A recent study reveals that ezetimibe monotherapy increases serum coproporphyrin I (CPI) concentrations in healthy individuals, potentially affecting OATP1B1 function. • Co-administration of ezetimibe and rifampin further elevates CPI levels, complicating the assessment of drug interactions in patients undergoing combination therapies. • The research supports CPI as a reliable biomarker for monitoring OATP1B1 activity, crucial for personalized medicine approaches and reducing adverse drug reactions. • Ezetimibe-glucuronide, a metabolite of ezetimibe, significantly reduces cellular CPI accumulation, suggesting a broader role in modulating transporter function beyond cholesterol reduction.

Eisai has completed its rolling submission to the U.S. FDA for a subcutaneous autoinjector of LEQEMBI® (lecanemab-irmb) for Alzheimer's disease maintenance therapy.

Reunion Neuroscience is actively enrolling patients in the Phase 2 RECONNECT trial of RE104 for postpartum depression, with topline data expected mid-2025.

• LimmaTech Biologics' LBT-SA7 vaccine candidate receives FDA Fast Track designation to prevent Staphylococcus aureus skin and soft-tissue infections. • The multivalent toxoid vaccine addresses the urgent need for new treatments due to increasing antibiotic resistance and the lack of available vaccines. • A Phase 1 clinical trial involving 130 participants aged 18-50 is planned, with initial results expected in the second half of 2025. • The FDA's decision highlights its commitment to addressing serious health threats and facilitating the development of innovative medical solutions.

The Sean M. Healey & AMG Center for ALS at Mass General has updated the master protocol for the HEALEY ALS Platform Trial to streamline research and improve efficiency.

A study of type 2 diabetes patients not on bolus insulin showed that continuous glucose monitoring (CGM) significantly improved glycemic control compared to standard care.

Sensome announced positive results from two studies on its Clotlid smart guidewire, which identifies blood clots in real-time during PAD procedures.

Repare Therapeutics' MYTHIC trial shows reduced Grade 3 anemia with lunresertib and camonsertib combination, with FDA agreement on RP2D.

The FDA has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody products used in the U.S. government's COVID-19 response.

The FDA has granted accelerated approval to Elevidys, the first gene therapy for Duchenne muscular dystrophy (DMD) in certain pediatric patients aged 4-5.

Treatment with lutetium-177 dotatate (177Lu-dotatate) demonstrated activity in patients with surgery- or radiation-refractory grade 2/3 meningioma.

Fitusiran, an siRNA therapeutic targeting antithrombin, shows high efficacy as a prophylactic agent for hemophilia A and B in the ATLAS-OLE trial.

Orserdu shows comparable real-world effectiveness to EMERALD trial results in HR-positive/HER2-negative advanced breast cancer with ESR1 mutations.

A clinical trial in the Philippines is evaluating virgin coconut oil (VCO) as a potential treatment for COVID-19, with results anticipated by December.

Takeda's TAK-279, an oral TYK2 inhibitor, demonstrates significant skin clearance in Phase 2b trials for moderate to severe plaque psoriasis.

The INSIGHT-003 trial, evaluating eftilagimod alpha (efti) with pembrolizumab and chemotherapy, has completed enrollment with approximately 50 patients.

Boundless Bio will not advance BBI-825 into Part 2 of the STARMAP trial due to pharmacokinetic data and the evolving treatment landscape.