Clinical Trial News

FDA approves ALYFTREK, a once-daily CFTR modulator for cystic fibrosis in patients 6+ with responsive mutations, including 31 not responsive to other therapies. ALYFTREK showed non-inferiority to TRIKAFTA in ppFEV1 and decreased sweat chloride.

Zepbound, approved for treating obstructive sleep apnea (OSA) in obese patients, is the first medication to significantly improve moderate-to-severe OSA and aid long-term weight loss. OSA, underdiagnosed and linked to obesity and Type 2 diabetes, involves airway blockage during sleep causing apneic episodes. Clinical trials showed Zepbound eliminated OSA symptoms in 43% and 51% of patients.

FDA approves Eli Lilly's Zepbound for moderate-to-severe sleep apnea and obesity, marking the first medication for obstructive sleep apnea. Zepbound, a GLP-1 drug, should be used with a reduced-calorie diet and increased physical activity. Studies show it reduces breathing pauses and promotes weight loss, though side effects include nausea and stomach discomfort. Concerns over GLP-1 medication prices persist.

The FDA approved Eli Lilly’s weight-loss treatment, Zepbound, for obstructive sleep apnea, the first drug to directly treat the disorder. The approval is for moderate to severe obstructive sleep apnea in adults with obesity, potentially expanding the market and strengthening Lilly’s case with insurers. Zepbound, a GLP-1 agonist, also reduces food cravings and slows stomach emptying, with trial data showing it eased breathing difficulties and lowered sleep apnea biomarkers.

Joseph Zackular discussed declining hospital-onset C difficile infections due to better infection control and an mRNA-based vaccine in pre-clinical trials. Antimicrobial resistance (AMR) is fueled by public misunderstanding and misuse of antibiotics. Peer-assisted telemedicine improved HCV diagnosis and treatment in rural areas. The CACTUS Study found similar outcomes for ceftolozane-tazobactam and ceftazidime-avibactam in treating multidrug-resistant Pseudomonas aeruginosa infections. Gilead's lenacapavir demonstrated high efficacy in preventing HIV infection in Phase 3 trials.

Bentley, diagnosed with B-ALL in 2019, was enrolled in a clinical trial using blinatumomab with chemotherapy, achieving remission and remaining disease-free. The trial, halted early due to clear benefits, showed 96% of standard-risk B-ALL patients remained relapse-free at three years with the combination therapy. Blinatumomab, a targeted therapy with fewer side effects, is now standard practice for standard-risk B-ALL.

Adding Darzalex to VRd improved minimal-residual disease (MRD) responses and progression-free survival (PFS) in transplant-ineligible or -deferred newly diagnosed multiple myeloma patients, according to the phase 3 CEPHEUS trial. The overall MRD-negativity rate was 60.9% with Darzalex plus VRd versus 39.4% with VRd alone at 10^-5 sensitivity, and 46.2% versus 27.3% at 10^-6 sensitivity. The 54-month PFS rates were 68.1% and 49.5%, respectively, reducing the risk for disease progression or death by 43%. Darzalex also almost doubled the MRD-negative complete response rates sustained for more than 12, 24, and 36 months.

U.S. FDA approved Eli Lilly's Zepbound, a weight-loss drug, for treating moderate to severe obstructive sleep apnoea (OSA) in obese adults. Zepbound works by reducing appetite and food intake, improving OSA through weight loss. It is administered weekly with exercise and a reduced-calorie diet.

Zepbound, a weight loss drug by Eli Lilly & Co., is the first prescription medication approved by the FDA to treat obstructive sleep apnea (OSA) in adults with obesity. The drug, used with a reduced-calorie diet and exercise, aids weight loss and reduces OSA symptoms. Studies showed significant reductions in shallow breathing or pauses in breathing among Zepbound users compared to placebo.

Researchers from Leiden University Medical Center and Radboud University engineered mosquitoes to deliver vaccines, potentially enhancing immunity against malaria. The vaccine uses a weakened Plasmodium falciparum parasite, which does not cause disease symptoms. Trials showed 13% and 89% immunity in GA1 and GA2 groups, respectively. Further research is needed for larger-scale testing and protection against different malaria strains.