Clinical Trial News
Lamassu Biotech Partners with Ohio State University for Dual-Species Acute Pancreatitis Treatment Development
• Lamassu Biotech has established a collaboration with The Ohio State University to advance RABI-767, a novel therapeutic targeting acute pancreatitis in both humans and dogs.
• The partnership will conduct companion clinical trials at Ohio State's College of Veterinary Medicine to evaluate RABI-767's efficacy in treating spontaneous canine acute pancreatitis.
• Acute pancreatitis affects over 330,000 humans annually in the United States and nearly 1.8 million dogs, with no effective treatments currently available for either species.
• The collaboration follows Lamassu's launch of its new Lamassu Pets division, expanding the company's pipeline to include veterinary applications of its human therapeutics.
NICE Extends Access to Brineura for CLN2 Batten Disease While Seeking Long-term Solution
• NICE has secured continued access to cerliponase alfa (Brineura) for current patients and those starting treatment before December 2025, despite not recommending it for routine NHS use due to cost concerns.
• The enzyme replacement therapy, costing over £500,000 per patient annually, has demonstrated effectiveness in slowing CLN2 progression in the short term, but lacks sufficient long-term efficacy data.
• NICE, NHS England, and manufacturer BioMarin continue negotiations to reach a sustainable pricing agreement that could extend access to all future patients with this rare, life-limiting condition.
Novartis Receives CDSCO Approval for Phase IIIb Trial of Asciminib in Chronic Myeloid Leukemia
• Novartis Healthcare has secured approval from India's CDSCO expert committee to conduct a Phase IIIb roll-over study of asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia.
• Asciminib (ABL001) functions as a novel allosteric inhibitor targeting the BCR-ABL1 kinase's myristoyl pocket, distinguishing it from traditional ATP-competitive tyrosine kinase inhibitors used in CML treatment.
• The multi-center, open-label study will assess long-term safety in patients who have completed previous Novartis-sponsored asciminib trials and are deemed to benefit from continued treatment.
Biocon Plans ₹4,500 Crore QIP to Reduce Debt and Increase Biologics Stake
• Biocon chairperson Kiran Mazumdar-Shaw announced plans for a ₹4,500 crore qualified institutional placement to convert structured venture debt into equity, aiming to strengthen the company's balance sheet.
• The fundraising initiative comes after Biocon Biologics' $3.3 billion acquisition of Viatris's global biosimilars business in 2022, which left the company with approximately $1.2 billion in acquisition-related debt.
• Despite generating 25% EBITDA on over $1 billion in sales, Biocon's profitability has been significantly impacted by debt provisioning, with the company now considering merging Biologics with the parent company instead of pursuing an IPO.
ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer
• The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer.
• Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients.
• ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.
Highlighted Clinical Trials:
Jules Bordet Institute
Posted 1/14/2021
Eli Lilly and Company
Posted 8/1/2015
CanSino's Inhaled TB Booster Vaccine Advances with Clinical Trial Approval in Indonesia
• CanSino Biologics has received clinical trial approval in Indonesia for its innovative inhaled tuberculosis booster vaccine, marking a significant advancement in TB prevention strategies.
• The inhaled delivery system represents a novel approach to tuberculosis vaccination, potentially offering advantages over traditional injection methods in terms of administration and efficacy.
• This development comes amid global efforts to combat tuberculosis, which remains one of the world's deadliest infectious diseases despite existing prevention measures.
Align Technology's Invisalign Palatal Expander System Receives NMPA Approval in China
• Align Technology has secured NMPA approval in China for its Invisalign Palatal Expander System, a direct 3D-printed orthodontic device designed for maxillary expansion in patients of all ages.
• The innovative system offers a removable alternative to traditional metal expanders, providing customized treatment based on iTero intraoral scans and proprietary orthodontic software.
• Commercial availability is expected in the second half of 2025, complementing Align's existing early intervention solutions and strengthening its position in the growing digital orthodontics market.
Skin Cancer Awareness Month: Multimodal Approaches and Prevention Strategies Highlighted by Experts
• Approximately 90% of skin cancers are preventable, with limiting sun exposure in the first 20 years of life being crucial as most lifetime UV damage occurs by age 20.
• Advancements in skin cancer treatment include immunotherapy for metastatic melanoma, targeted agents for large basal cell cancers, and multimodality approaches where specialists collaborate on complex cases.
• Radiation therapy remains an underutilized option for elderly or frail patients with skin cancer, particularly in cases where surgery might cause functional or structural damage.
Novo Nordisk CEO Lars Fruergaard Jørgensen to Step Down After Eight-Year Tenure
• Novo Nordisk has announced that CEO Lars Fruergaard Jørgensen will step down following a mutual agreement with the board, ending his eight-year leadership during which the company established itself as a pioneer in obesity treatment.
• The leadership change comes amid market challenges including a declining share price and increased competition from Eli Lilly's tirzepatide, which recently outperformed Novo's semaglutide in a head-to-head weight loss trial.
• Former CEO Lars Rebien Sørensen, current Novo Nordisk Foundation chair, will begin attending board meetings immediately as an observer with plans for formal board nomination in 2026, signaling the foundation's push for greater influence.
Highlighted Clinical Trials:
Eli Lilly and Company
Posted 4/21/2023
Acquired Hemophilia A Pipeline Expands with 10+ Novel Therapies in Development
• Global Acquired Hemophilia A pipeline comprises over 10 companies developing innovative therapies across various clinical stages, according to DelveInsight's 2025 report.
• Recent clinical advances include promising results for rituximab as a potential first-line therapy and Pfizer's positive Phase 3 AFFINE trial results for giroctocogene fitelparvovec gene therapy.
• Key pharmaceutical players including Novo Nordisk, Sanofi, Pfizer, and Belief Biomed are advancing treatments ranging from gene therapies to monoclonal antibodies targeting this rare autoimmune bleeding disorder.
Highlighted Clinical Trials:
Pfizer
Posted 8/18/2020