Clinical Trial News

FDA approves Pfizer's BRAFTOVI (encorafenib) with cetuximab and mFOLFOX6 for metastatic colorectal cancer (mCRC) with BRAF V600E mutation. Based on BREAKWATER trial, the combination showed significant improvement in response rate and durability. This is the first BRAF-targeted therapy regimen for first-line treatment of BRAF V600E-mutant mCRC.

Humacyte's SYMVESS, a bioengineered vascular conduit, received FDA full approval for extremity arterial injury repair, offering high patency and low amputation/infection rates, with a trained sales team ready for commercial launch.

Pfizer's BRAFTOVI® (encorafenib) in combo with cetuximab and mFOLFOX6 approved by FDA for first-line treatment of metastatic colorectal cancer with BRAF V600E mutation, based on 61% overall response rate in Phase 3 BREAKWATER trial.

The FDA expanded Eli Lilly's Zepbound approval to treat moderate to severe obstructive sleep apnea in obese individuals, the first medication for the condition. Zepbound, aiding weight loss, reduced breathing interruptions and improved sleep apnea symptoms in a study. Insurance providers, including Medicare, may cover it for this dual condition.

Eli Lilly's Zepbound, a weight-loss drug, was approved by the FDA to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. Clinical trials showed Zepbound reduced breathing disruptions five times more than a placebo and led to significant weight loss. This approval may allow Zepbound to be covered by Medicare, similar to Novo Nordisk's Wegovy.

GBS incidence slightly higher than expected in older adults after RSV vaccination, but remains rare. Arexvy (GSK) reported more serious adverse events than Abrysvo (Pfizer), though GBS rates were similar. More adverse events in 60-74 age group and women, but GBS rates consistent. Benefits of RSV vaccination outweigh risks for older adults.

FDA issued a complete response letter to Zealand Pharma, stating the glepaglutide NDA for short bowel syndrome is not ready for approval and recommends an additional clinical trial. Zealand Pharma remains confident in glepaglutide's efficacy and safety, aiming to reduce parenteral support needs in SBS patients.

Avacta Group (AIM: AVCT) pioneers cancer treatment via its pre|CISION™ platform, developing peptide drug conjugates (PDCs) to deliver chemotherapy directly to tumors, minimizing side effects. Its lead therapeutic, AVA6000, shows promise in Phase 1 trials for aggressive cancers. The pre|CISION™ platform reduces systemic toxicity, positioning Avacta as a leader in precision oncology. With over £32 million in cash reserves, Avacta faces clinical trial risks but is well-positioned for growth in 2025.

IACS and Castor partnered to use Focused Ultrasound Neuromodulation (FUS) for deepening meditative states, leveraging Castor's platform to streamline clinical trials, expediting setup 2.67 times. Preliminary results showed FUS significantly impacted meditative depth during caudate stimulation, improving mood and physiological responses.

Odronextamab combinations may help elicit responses in DLBCL patients after CAR T-cell therapy failure. Duration of prior CAR T-cell therapy benefit predicts bispecific antibody response. Developing combination approaches with odronextamab aims to mitigate disease progression and elicit responses.