Clinical Trial News
International R&D Partnerships Drive Innovation and Accessibility in Generic Drug Development
• International research and development collaborations are becoming increasingly vital for generic drug manufacturers to overcome complex challenges in bringing affordable medications to market.
• These cross-border partnerships facilitate knowledge sharing, resource pooling, and technology access, resulting in accelerated development timelines and improved product quality.
• By addressing key obstacles such as intellectual property protection, regulatory compliance, and supply chain logistics, these collaborations are expanding global access to essential medicines.
FDA Clears Avenzo Therapeutics' IND for AVZO-023, a Novel CDK4 Selective Inhibitor for Advanced Breast Cancer
• Avenzo Therapeutics has received FDA clearance for its investigational new drug application for AVZO-023, a highly selective CDK4 inhibitor with potential best-in-class properties for treating HR+/HER2- breast cancer.
• The company plans to initiate a Phase 1/2 clinical trial in Q3 2025, evaluating AVZO-023 as monotherapy and in combination with endocrine therapy and their CDK2 inhibitor AVZO-021.
• Preclinical data presented at AACR 2025 demonstrated AVZO-023's sub-nanomolar potency against CDK4 with high selectivity over CDK6, potentially reducing hematologic toxicity common with current CDK inhibitors.
Sanofi to Acquire Vigil Neuroscience for Up to $600 Million, Expanding Alzheimer's Disease Pipeline
• Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for $8.00 per share in cash upfront, with an additional $2.00 per share contingent value right tied to VG-3927's first commercial sale.
• The acquisition strengthens Sanofi's neurology pipeline with VG-3927, a Phase 2-ready oral small molecule TREM2 agonist being developed for Alzheimer's disease, targeting microglial dysfunction in neurodegenerative disorders.
• The transaction, valued at approximately $600 million including the potential CVR payment, is expected to close in the third quarter of 2025, with Vigil's monoclonal antibody program iluzanebart not included in the acquisition.
ONWARD Medical Advances Brain-Computer Interface Technology with Fifth Successful Implant for Spinal Cord Injury Patients
• ONWARD Medical has successfully implanted its ARC-BCI® Therapy in two additional patients, bringing the total to five individuals with spinal cord injuries who can now potentially control movement through thought.
• The innovative DigitalBridge™ system creates a wireless connection between brain and spinal cord, using AI to decode neural signals and translate intention into movement, bypassing damaged neural pathways.
• With FDA Breakthrough Device Designation and growing clinical evidence, ONWARD's less invasive BCI approach is positioning the company as a leader in neurotechnology for restoring function after paralysis.
ReproNovo Secures $65 Million Series A Funding to Advance Novel Reproductive Medicine Therapies
• ReproNovo has raised $65 million in Series A financing led by Jeito Capital to advance two Phase 2-ready compounds targeting male infertility, adenomyosis, and embryo implantation success.
• The company's lead candidates include RPN-001 (leflutrozole) for male infertility due to low testosterone levels and RPN-002 (nolasiban) for adenomyosis treatment and improving assisted reproductive technology outcomes.
• This investment addresses critical gaps in reproductive medicine amid declining global fertility rates, with male sperm counts having fallen by 50-60% over the past four decades.
California's AB 824 Pharmaceutical Patent Settlement Law Faces Permanent Injunction Limiting Enforcement
• A federal court has issued a permanent injunction limiting California's AB 824 law, which presumes pharmaceutical "reverse payment" patent settlements are anticompetitive, to agreements negotiated or entered within California's borders.
• AB 824 differs significantly from federal standards by creating a presumption of illegality for settlements where generic manufacturers receive "anything of value" while delaying market entry, with potential penalties of $20 million or more.
• Pharmaceutical companies must carefully consider where settlement discussions occur and document procompetitive rationales, as questions remain about enforcement when parties have California connections or when agreements affect in-state sales.
Rainbow Children's Hospital Completes Eighth Zolgensma Gene Therapy for Spinal Muscular Atrophy in India
• Rainbow Children's Hospital in Secunderabad, India has successfully administered its eighth Zolgensma gene therapy treatment for Spinal Muscular Atrophy, a rare genetic neuromuscular condition affecting approximately 1,000 children in India.
• The one-time gene therapy, which costs approximately Rs 14 crore (USD 1.7 million) per dose, works by replacing the defective SMN1 gene using adeno-associated viral vector technology to enable production of essential SMN protein.
• Following treatment, patients require continuous monitoring by a multidisciplinary team and weekly laboratory investigations to identify potential adverse events and enable early intervention.
South Rampart Pharma Secures New Investment for Novel Non-Opioid Pain Treatment
• South Rampart Pharma has secured investment from Gulf South Angels to advance SRP-001, a non-opioid pain medication that targets the central nervous system, into FDA fast-tracked Phase Two clinical trials.
• The New Orleans-based company, spun out of LSU Health School of Medicine in 2016, has raised $9 million to date and is seeking an additional $8.5 million in Series A funding for crucial efficacy testing.
• SRP-001 differentiates itself from recently approved non-opioid alternatives by targeting the central nervous system rather than peripheral neurons, potentially addressing the critical need for non-addictive pain management solutions.
FTC Issues New Warnings to Teva and Novartis Over Improper Orange Book Patent Listings
• The Federal Trade Commission has renewed challenges against Novartis, Teva, and other pharmaceutical companies for allegedly improper patent listings in the FDA's Orange Book.
• The disputed listings involve more than 200 patents across 17 brand-name products, primarily for asthma, diabetes, epinephrine autoinjectors, and COPD medications.
• According to the FTC, these improper device patent listings may delay generic competition, artificially inflate drug prices, and restrict patient access to affordable medications.
Montara Therapeutics Receives $3.3M Grant from Michael J. Fox Foundation to Develop Brain-Selective LRRK2 Inhibitor for Parkinson's
• Montara Therapeutics has been awarded a $3.3 million grant from The Michael J. Fox Foundation to develop a novel brain-selective LRRK2 inhibitor for Parkinson's disease using their BrainOnly™ platform.
• The BrainOnly™ platform combines a brain-penetrant drug with a peripheral blocker to create brain-specific pharmacology, potentially avoiding the lung and kidney toxicity that has hindered previous LRRK2 inhibitor development.
• As part of the collaboration, Montara will join the LRRK2 Investigative Therapeutics Exchange (LITE) program, which fosters international collaboration across academic centers and companies to advance LRRK2-targeted therapeutics.