Clinical Trial News

SI-BONE, Inc. received FDA 510(k) clearance for its iFuse TORQ TNT implant system, designed for pelvic fragility fractures. TNT offers improved treatment over current standards, featuring anatomy-specific design for early fixation and reduced screw backout. The global sacroiliac joint fusion market, valued at $721.2 million in 2023, is expected to grow, supported by technological advancements and increasing prevalence of related conditions.

The European Commission approved Celltrion's SteQeyma, a biosimilar to Stelara, for chronic inflammatory conditions. SteQeyma, effective against IL-12 and IL-23, offers subcutaneous and intravenous formulations. It matches Stelara in efficacy and safety, marking Celltrion's seventh EU-approved biosimilar, enhancing access to affordable biologics.

Rhythm Pharmaceuticals seeks FDA approval to expand IMCIVREE® (setmelanotide) use for treating obesity in children as young as 2 with Bardet-Biedl syndrome or POMC/LEPR deficiency, with a PDUFA goal date of December 26, 2024. The sNDA is based on Phase 3 trial data showing efficacy in reducing BMI in young children.

Izotropic Corporation is advancing its regulatory strategy to launch IzoView, a breast CT imaging system, in the U.S. and EU. The device is aimed at diagnosing breast cancer in patients with dense breast tissue, utilizing a clinical study to prove its efficacy alongside digital breast tomosynthesis.

Wegovy (semaglutide) reduces major adverse cardiac events by 28% in heart failure patients, regardless of ejection fraction type, and also lowers heart disease-related and all-cause mortality.

A study involving 39,000 women, including 7,300 with migraines, found no increased risk of Parkinson's disease among those with migraines. Published in the journal *Neurology*, the research suggests no association between migraines and Parkinson's, regardless of migraine frequency or aura presence.

Lixte Biotechnology Holdings, Inc. (NASDAQ:LIXT) received a Nasdaq non-compliance notice for falling below the $2.5M stockholders' equity requirement. It has 45 days to submit a compliance plan, with a possible 180-day extension. The company is exploring options to regain compliance, while its shares continue trading. Recent changes include a shift to equity-based director compensation and a clinical trial agreement with the Netherlands Cancer Institute for cancer drug LB-100.

The global mRNA cancer vaccines clinical trials and market future outlook for 2024 highlights over 60 vaccines in clinical trials, with the highest phase being Phase III. The US and China dominate the trials, with skin cancer vaccines leading. mRNA vaccines offer a personalized, targeted approach to cancer treatment, leveraging the body's immune system to combat cancer cells. They are being explored as combination therapies and for preventing cancer recurrence, with early results showing promise.

Elinzanetant, a dual NK-1 and 3 receptor antagonist, showed efficacy and safety in Phase III OASIS 1 and 2 studies for treating moderate to severe VMS in menopause, reducing VMS frequency and severity, and improving sleep disturbances and quality of life.

Moderna's updated COVID-19 vaccine targeting KP.2 variant of SARS-CoV-2 has been approved by the U.S. FDA for individuals 12 years and above, with EUA granted for those 6 months through 11 years. The vaccine aims to prevent COVID-19 and is expected to be available soon.