Switzerland's updated clinical trials framework introduces new rules and requirements for conducting clinical trials within the country.

Eli Lilly has received approval to launch its tirzepatide injections, branded as Mounjaro, in Hong Kong.

A mutation in the Shigella sonnei bacteria has led to an extensively drug-resistant (XDR) Shigellosis outbreak in Los Angeles, with California reporting 4,365 of the 20,621 cases nationwide in 2024. The mutation makes the bacteria resistant to cephalosporins, a class of antibiotics, highlighting the urgent need for improved detection and management strategies.

Kadmon is set to file for FDA approval of belumosudil, a potential first-in-class treatment for chronic graft versus host disease (GVHD), after achieving positive results in a pivotal Phase 3 trial. The drug showed significant improvement in symptoms for nearly three-quarters of patients, with effects lasting at least six months.

Synergia Medical, a preclinical medical device company, has successfully raised €9 million in Series B funding. This financial boost will support the company's preparation for First-In-Human clinical trials of its NAO.VNS device, aimed at treating drug-resistant epilepsy, and the submission of an Investigational Device Exemption to the FDA in 2023.

Innate Pharma SA has announced a comprehensive strategy aimed at driving sustainable growth and innovation in pharmaceutical R&D. Key highlights include the presentation of lacutamab's quality-of-life improvements in CTCL patients, a significant investment for IPH6501 development in follicular lymphoma, and FDA clearance for a new ADC targeting solid tumors.

Adeno-associated virus (AAV) gene therapy is emerging as a promising treatment for hemophilia A and B, offering the potential for long-term factor expression and reduced bleeding episodes. This article reviews the clinical development of AAV gene therapy, its efficacy, safety considerations, and the challenges of pre-existing immunity to AAV vectors.

A phase II clinical trial, JANUS, evaluated the safety and efficacy of atacicept in patients with IgA nephropathy (IgAN) and persistent proteinuria. The study found atacicept to have an acceptable safety profile and demonstrated its effectiveness in reducing levels of pathogenic factor Gd-IgA1, with potential improvements in proteinuria and renal function.

Attralus, Inc. has announced the enrollment of the first subject in its Phase 1 clinical trial for AT-02, a novel therapeutic aimed at treating systemic amyloidosis by removing toxic amyloid fibrils. The trial will assess the safety, tolerability, and pharmacokinetics of AT-02 in both healthy volunteers and patients with systemic amyloidosis.

Avacta Group plc has made significant strides in its oncology pipeline, including the presentation of new preclinical data on its pre|CISION™ platform and the initiation of a strategic AI-driven collaboration with Tempus AI. Additionally, the company reported updated Phase 1 clinical data for AVA6000, showing promising results in solid tumors.

Recent studies from the TRACERx cohort reveal significant insights into non-small-cell lung cancer (NSCLC) evolution, including the role of FAT1 alterations in chromosomal instability and the impact of aging on immune response. Additionally, advancements in ctDNA detection and DNA methylation signatures offer promising directions for personalized treatment and metastasis prediction.

A phase 3 trial demonstrates that SHR-1701, when combined with CAPOX chemotherapy, effectively reduces chemotherapy-related bone marrow suppression in patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma. The combination therapy showed lower rates of treatment delays and dose reductions, with fewer instances of severe hematological toxicities compared to placebo.

A Phase 3 trial evaluating Merck and Eisai's combination of Keytruda (pembrolizumab) and Lenvima (lenvatinib) demonstrated improved progression-free survival but failed to show overall survival benefit in HER2-negative gastroesophageal adenocarcinoma. The LEAP-015 study results highlight the complex nature of treating advanced gastric cancer while maintaining the drugs' existing approved indications.

Alebund Pharmaceuticals, a leader in innovative kidney disease treatments, has successfully closed a Pre-C round of financing, raising nearly RMB 200 million. The funds will bolster the company's R&D pipeline, which includes three Class I innovative drugs in various stages of clinical development, with additional products expected to enter clinical testing by 2024.

The FDA has finalized a rule to expand access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy. This rule aims to increase awareness and knowledge of expanded access programs, detailing criteria, submission requirements, and safeguards for different types of expanded access.

A groundbreaking study demonstrates the effectiveness of combining Intense Pulsed Light (IPL) and Botulinum neurotoxin Type A (BoNT/A) in treating erythematotelangiectatic rosacea. The research, conducted on Latin American patients with Fitzpatrick skin type III, showed significant improvement in rosacea symptoms, with 12 out of 14 patients achieving mild or normal status post-treatment.

ENA Respiratory has successfully completed Phase Ib dosing of INNA-051 dry powder formulation in adults over 60, demonstrating good tolerability and activation of innate immune pathways. The new formulation offers improved stability with a two-year shelf life at room temperature, positioning it as a potential seasonal preventive treatment for viral respiratory infections.

A phase I/II clinical trial of HE072, a novel liposomal irinotecan formulation, demonstrated encouraging efficacy in heavily pretreated metastatic triple-negative breast cancer (TNBC) patients. The study established 70 mg/m2 as the recommended Phase 2 dose, with a 25.3% partial response rate and median progression-free survival of 4.8 months in TNBC patients.

A Phase 2 pilot trial investigating very low doses of rituximab in cold agglutinin disease (CAD) patients showed initial success in B-cell depletion but failed to maintain sustained suppression. The European study, involving seven CAD patients, suggests that current low-dose regimens may not be sufficient for long-term treatment of autoimmune hemolytic anemia.

Mark Sommerville, a Lanarkshire father diagnosed with motor neurone disease (MND), is supporting a £350,000 fundraising campaign to accelerate the clinical trial of Ellorarxine, a drug believed to reverse the effects of MND. The campaign aims to fast-track the drug's development and manufacturing process, offering hope to MND and Frontotemporal dementia (FTD) patients.