Clinical Trial News

T2 Biosystems received FDA clearance to market its T2Candida Panel for pediatric patients, enabling faster detection of sepsis-causing Candida species directly from blood in 3-5 hours.

Sanofi ships BEYFORTUS doses in the US to protect eligible babies against RSV, with a new FDA-approved filling line expanding manufacturing capacity. BEYFORTUS is the first long-acting monoclonal antibody for RSV prevention in newborns and infants up to 24 months.

Shuttle Pharmaceuticals expands Phase 2 trial for Ropidoxuridine, a radiation sensitizer for glioblastoma, adding two sites to total four out of six planned. Targeting IDH wild-type, methylation negative patients, the trial aims to improve outcomes for this aggressive brain cancer. The study will enroll 40 patients initially, with an additional 14 to achieve statistical significance, expected to complete in 18-24 months.

Cabometyx® (cabozantinib) showed significant reduction in disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, according to data from the CABINET Phase III trial. The results were presented at ESMO 2024 and published in the New England Journal of Medicine. Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency.

Cabometyx (cabozantinib) showed significant reduction in disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, according to final data from the CABINET Phase III trial. Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency. The data were presented at ESMO 2024 and published in the New England Journal of Medicine.

Cipher Pharmaceuticals' stock dropped due to Moberg Pharma's disappointing interim clinical update on MOB-015, a nail fungus treatment. Despite this, Research Capital's Andre Uddin maintains a 'Buy' rating on Cipher, citing MOB-015's previous efficacy and its approval in 13 European countries, predicting potential Health Canada approval and stock recovery.

GSK and iTeos Therapeutics' Phase II GALAXIES Lung-201 study showed Jemperli and belrestotug, an anti-TIGIT therapy, achieved a 60% objective response rate in non-small cell lung cancer patients, with a 30% improvement over Jemperli alone. The combination also led to significant reductions in circulating tumor DNA and was presented at ESMO 2024.

Final CABINET Phase III trial data showed Cabometyx significantly reduced disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, presented at ESMO 2024 and published in NEJM. Ipsen has submitted an extension of indication Marketing Authorization to the EMA, addressing limited treatment options for advanced NETs.

Australian researchers found the TSOS collaborative care intervention for PTSD and pain symptoms after major traumatic injury feasible and low-cost in Victoria, Australia, with preliminary evidence suggesting reduced symptoms.