GSK Acquires Efimosfermin for $1.2 Billion to Target Steatotic Liver Disease
• GSK has agreed to acquire efimosfermin alfa from Boston Pharmaceuticals for $1.2 billion upfront, with potential additional milestone payments of $800 million, strengthening its hepatology pipeline.
• Efimosfermin, a phase III-ready FGF21 analog, has shown promising results in reversing liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH), with a convenient once-monthly dosing regimen.
• Steatotic liver disease affects approximately 5% of the global population with limited treatment options, and interventions that reduce fibrosis could save the US healthcare system between $40-100 billion over the next two decades.
Perfluorohexyloctane Shows Unprecedented Rapid Relief for Dry Eye Disease in Phase 4 Study
• A phase 4 multicenter study demonstrated that perfluorohexyloctane (MIEBO) provides significant dry eye symptom relief within just 5 minutes of application, showing nearly 50% improvement that continued to increase at subsequent timepoints.
• Patients reported high satisfaction with the treatment, with median satisfaction scores rising from 83.0 at Day 3 to 90.0 by Day 14, potentially supporting better treatment adherence for dry eye disease management.
• The medication's unique mechanism creates a barrier at the air-tear film interface that reduces evaporation, offering both rapid onset and sustained relief across multiple symptom domains including dryness, burning, irritation, and blurred vision.
REPOSE Study Confirms Real-World Efficacy of Higher-Dose OnabotulinumtoxinA for Chronic Migraine
• The two-year REPOSE study demonstrated that 156-195 U onabotulinumtoxinA significantly reduced monthly headache days in adults with chronic migraine, with reductions ranging from 8.7 to 14.2 days.
• Treatment with higher-dose onabotulinumtoxinA (156-195 U) showed comparable safety to the standard 155 U dose, with eyelid ptosis, neck pain, and musculoskeletal stiffness being the most commonly reported adverse reactions.
• Quality of life measurements improved consistently across treatment visits for patients receiving both standard and higher doses, supporting the clinical benefit of onabotulinumtoxinA in real-world settings.
AbbVie Seeks FDA Approval for Novel Serotype E Botulinum Neurotoxin for Glabellar Lines
• AbbVie has submitted a Biologics License Application to the FDA for TrenibotE (trenibotulinumtoxinE), a first-in-class serotype E botulinum neurotoxin for treating moderate to severe glabellar lines.
• TrenibotE demonstrates a differentiated clinical profile with rapid onset of action within 8 hours and shorter duration of 2-3 weeks, potentially addressing patient concerns about "looking unnatural" with traditional neurotoxins.
• The submission is supported by data from over 2,100 patients across two pivotal Phase 3 trials and a long-term safety study, all of which met primary and secondary endpoints with a safety profile comparable to placebo.
Galapagos CEO Paul Stoffels to Step Down as Company Splits into Two Entities
• Paul Stoffels will retire as Galapagos CEO within 12 months after three years at the helm, during which he transformed the company's focus to cell therapy and oncology through strategic acquisitions.
• Galapagos is separating into two entities: the original company will retain cell therapy assets while a new spin-off company (SpinCo) will control €2.45 billion ($2.8 billion) in cash from the Gilead partnership.
• Henry Gosebruch, former Neumora CEO with extensive M&A experience, has been appointed to lead SpinCo with a mandate to build a pipeline through acquisitions of assets with proven proof-of-concept data.
Verrica Pharmaceuticals Reports Record Growth in YCANTH® Dispensed Units for Molluscum Contagiosum Treatment
• Verrica Pharmaceuticals achieved a milestone with over 10,000 YCANTH® dispensed applicator units in Q1 2025, representing a 16.7% sequential increase from the previous quarter.
• The company reports normalized distribution inventory levels, indicating that dispensed units will now more closely track actual demand and gross revenue.
• Following a commercial restructuring, Verrica is positioned for sustainable revenue growth as it works to establish YCANTH® as the standard of care for molluscum contagiosum.
FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications
• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar.
• JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others.
• The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.
SpyGlass Pharma Appoints Veteran Pharmaceutical Executive as Chief R&D Officer to Advance Intraocular Drug Delivery Platform
• SpyGlass Pharma has appointed Chetan Pujara, Ph.D., as Chief Research & Development Officer to lead the company's proprietary intraocular drug delivery platform into Phase 3 trials.
• Dr. Pujara brings over 20 years of leadership experience in pharmaceutical development and has contributed to market-leading products including Ozurdex®, Durysta™, and other ophthalmic therapies.
• The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver three years of sustained medication release for glaucoma patients, with potential applications in additional ophthalmic conditions.
Five-Year Study Shows Aflibercept Treat-and-Extend Regimen Maintains Vision in Neovascular AMD Patients
• A multicenter Japanese study demonstrates that aflibercept using a treat-and-extend regimen maintained baseline visual acuity and significantly reduced central macular thickness in neovascular AMD patients over five years.
• Researchers identified smaller greatest linear dimension (GLD) as the only independent risk factor associated with better vision outcomes after five years of treatment (p=0.0024).
• The study revealed patients required fewer injections after the first year, though 33% of discontinued cases experienced recurrence, with higher recurrence rates in those who had received more total injections.
Bipolar Depression Market Set to Grow Through 2034 with New Therapies in Pipeline
• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions.
• Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector.
• Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.
Topical Drug Delivery Market Set to Reach $454.93 Billion by 2031 as Targeted Delivery Technologies Advance
• The global topical drug delivery market is projected to grow from $226.31 billion in 2023 to $454.93 billion by 2031, representing a CAGR of 9.1%, driven by increasing demand for non-invasive treatment options.
• Targeted drug delivery devices market is expected to grow at a faster CAGR of 19.7% through 2035, with intratumoral delivery dominating the segment and immunotherapy applications leading current market share.
• Technological advancements in drug delivery systems are enabling more precise administration to specific organs, with devices targeting the brain showing promising growth potential despite breast-targeted devices currently driving overall market volume.
FDA Greenlights Amgen and Allergan's Herceptin Biosimilar Kanjinti Amid Patent Expiry
The FDA has approved Kanjinti (trastuzumab-anns), a biosimilar version of Roche's blockbuster breast cancer drug Herceptin, developed by Amgen and Allergan. The approval comes as Herceptin's main US patent expires, potentially opening the market to competition in a space where the reference drug generated $2.9 billion in US sales last year.
Study Reveals Critical Gaps in UK's Pharma-Doctor Payment Disclosure System
• New research from University of Bath and Lund University exposes significant transparency issues in the UK's voluntary pharmaceutical payment disclosure system, with £3.3 billion in research payments lacking recipient details.
• Study finds major pharmaceutical companies, including AstraZeneca and Bristol Myers Squibb, classify over 90% of healthcare professional payments as research-related, potentially obscuring financial relationships.
• Researchers advocate for legislation similar to the US Sunshine Act to replace the current self-regulated Disclosure UK system, emphasizing the need for stronger transparency measures.
Xenon Pharmaceuticals Advances Azetukalner Program for Epilepsy and MDD
• Xenon Pharmaceuticals is progressing its Phase 3 epilepsy program with azetukalner, anticipating topline data from the X-TOLE2 study in the second half of 2025.
• The company plans to initiate the X-NOVA2 Phase 3 trial for azetukalner in major depressive disorder (MDD) by the end of the year, expanding its therapeutic focus.
• Xenon is expanding its ion channel portfolio, with multiple candidates advancing towards IND filings in 2025, targeting Kv7, Nav1.7, and Nav1.1.
• Long-term data from the X-TOLE open-label extension study of azetukalner in focal onset seizures will be presented at the American Epilepsy Society (AES) annual meeting.
Ipsen Advances Neurotoxin Research for Spasticity Treatment, Aims to Develop Longer-Acting Therapies
• Ipsen is developing modified botulinum toxin-based treatments with extended duration of action, potentially reducing injection frequency and improving patient quality of life.
• Despite their proven efficacy in treating spasticity and other neurological conditions, botulinum neurotoxin treatments were deprioritized during COVID-19, highlighting the need for better recognition of their therapeutic value.
• Over 100 conditions have been identified as potential targets for neurotoxin therapy, with current applications including adult and pediatric spasticity, cervical dystonia, and severe hyperhidrosis.
Clinical Trial Data Sharing Initiatives Drive Innovation and Efficiency in Drug Development
• TransCelerate's Placebo & Standard of Care Data Sharing Initiative has established a repository containing data from 67,000 patients across 90 clinical trials, reducing study time by 30% in preliminary results.
• Industry-wide momentum for clinical trial data sharing is growing, with major stakeholders including FDA, EMA, and medical journals implementing new policies to promote transparency and collaboration.
• The Comparator Network Initiative has facilitated over $120 million in transactions, achieving 10-12% cost savings while enhancing drug supply chain safety and reducing investigational product waste.
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