Clinical Trial News

Sanofi initiates phase 3 for PCV21, a 21-valent pneumococcal conjugate vaccine, and expands collaboration with SK bioscience to develop next-gen PCVs for pediatric and adult populations, aiming to combat pneumococcal disease.

AstraZeneca's Tagrisso (osimertinib) approved in EU for treating locally advanced, unresectable NSCLC with EGFR exon 19 deletions or exon 21 mutations, not progressed post platinum-based CRT. Tagrisso reduced disease progression/death risk by 84% vs placebo in LAURA Phase III trial. Median PFS was 39.1 months vs 5.6 months for placebo. OS results remain immature.

JCR Pharmaceuticals announced the first patient dosed in Phase III trial of JR-142, a long-acting growth hormone therapy for pediatric growth hormone deficiency in Japan. The trial involves 54 pediatric patients and aims to compare JR-142's efficacy to JCR's existing product, Growject®, over a 52-week period.

Zealand Pharma announced the FDA issued a complete response letter for its NDA for glepaglutide, a GLP-2 analog for short bowel syndrome with intestinal failure. The FDA recommended an additional trial for efficacy and safety confirmation. Zealand Pharma remains committed to regulatory approval and plans a European MAA submission in 2025.

Sequana Medical announces US FDA approval of alfapump® for treating recurrent or refractory ascites due to liver cirrhosis, marking it the first active implantable medical device in the US for this purpose. The device automatically removes ascites into the bladder, with over 1,000 systems implanted. The US market opportunity is estimated at over $2 billion in 2025, with a planned commercial launch in H2 2025.

Ellipses Pharma launches first large-scale Phase 1/2 oncology trial in UAE for EP0031/A400, a next-gen RET inhibitor targeting RET-altered tumors, with trials underway in the US, Europe, and China.

The FDA approved Eli Lilly's tirzepatide (Zepbound) for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, to be used with a reduced-calorie diet and exercise. Zepbound, a once-weekly injectable, reduces body weight, which improves OSA, and is the first drug therapy for this condition. It showed significant reduction in breathing disruptions per hour and weight loss in clinical trials, posing a competitive challenge to CPAP device makers.

Sanofi and SK bioscience expand collaboration to develop next-gen pneumococcal conjugate vaccines (PCVs), initiating phase 3 for PCV21, the first 21-valent PCV candidate in infants & toddlers. The partnership aims to address unmet needs in invasive pneumococcal disease, leveraging both companies' expertise and capabilities.

FDA approves Alhemo®, a subcutaneous injection for hemophilia A or B with inhibitors, reducing bleeds by 86% in prophylaxis users.

HKBU's aptamer for treating X-linked hypophosphatemia (XLH) received Orphan Drug and Rare Pediatric Disease Designations from the U.S. FDA. The aptamer, Apc001, targets sclerostin's loop3 domain to promote bone formation without cardiovascular risks, and is set for clinical trials in China and the U.S.