CTEXLI Approved for Cerebrotendinous Xanthomatosis; SIGX1094 Wins Fast Track for Diffuse Gastric Cancer; Bavarian Nordic’s Chikungunya Vaccine Cleared for Ages 12+; UX111 Gene Therapy Gains Priority Review for Sanfilippo Syndrome; SUBLOCADE Label Update Approved
FDA Approves CTEXLI, the First-Ever Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disorder Mirum…
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FDA Grants 510(k) Clearance to Neonav® ECG Tip Location System; ClearPoint Neuro Secures EU MDR Certification for SmartFlow Cannula; Volta Medical’s AI-Driven Ablation Procedure Improves Outcomes in Persistent Atrial Fibrillation Trial; WhiteSwell Presents New Clinical Data on eLym System for Acute Heart Failure Treatment; J&J MedTech Introduces CEREGLIDE™ 92 Catheter System; Thermo Fisher Launches New Spatial Imaging System for Tissue Proteomics
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EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis; GSK’s Penmenvy Wins FDA Nod; Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT; Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings; FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment
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Newsletter/Whitepaper
The therapy for aHUS is primarily supportive, focusing on managing acute kidney injury and systemic complications, with renal replacement therapy required for patients with uremia, fluid overload, or electrolyte abnormalities. Specific treatments include plasma exchange and complement inhibitors like eculizumab and ravulizumab, the only two approved drugs for aHUS treatment. In 2023, the total market size for aHUS in the United States was ~USD 900 million and is projected to surpass USD 1.5 billion by 2034, growing at a CAGR of 4.5% from 2020 to 2034. Among emerging therapies, PIASKY (crovalimab) and FABHALTA (iptacopan) are expected to significantly impact the market.
A mid pharma client based in Germany, involved in late-stage development of a therapy for PID, with effective marketing and commercialisation presence in Europe, wanted to assess the launch readiness of competitors involved in the same arena for strategic positioning of their product. They wished to identify and evaluate the launch timelines, geographies of launch, First Launch company, commercial readiness, and salesforce of competitors.
A large pharma client was working to develop their cyclophosphamide API and FD and was interested to assess competitive products in the same domain and area to provide benchmarking of their asset in comparison to their competitors The client requested periodic reports (Quarterly) on the developmental milestones of competitor companies, thorough assessment of the competitor products through Secondary and Primary CI inputs.
A mid-sized pharma client was working to develop their asset portfolio and was interested in assessing best possible asset for atrial fibrillation for future development and licensing needs. The client requested evidence-based priorities in assets and products for Phase II development in atrial fibrillation, through potential licensing collaborations. Also, the client wanted to prioritise research efforts to determine the best possible asset to leverage their research portfolio.
A small pharmaceutical client based at Sweden, Europe with capabilities around a neonatal mesenchymal cells involved DelveInsight to identify a licensing partner for their stem cells product, from across the globe. They wished to identify a potential list of companies, to become a fit for their neonatal high quality MSCs and can prove to be a good business partner as a licensee for their proprietary “API” of the stem cell therapy domain.
A large client based in the USA, involved in drug delivery devices, with effective marketing and commercialisation presence across the globe, wanted to in-license potential dMTS based drug delivery asset from companies involved in microneedle technology research for delivering therapeutic products. They wished to identify and assess the technological competencies, clinical capabilities and commercial readiness of potential companies with a novel and non-invasive way of delivering drugs, which can include a variety of drugs/vaccines in their patch and successfully develop the product for commercial purposes, were of client’s interest.
A medium pharmaceutical client based in the United States with biosimilar commercial capabilities involved DelveInsight to identify commercial processes and strategies to launch their biosimilar in Europe through Competitive Assessment of their EU based competitors in the same area of interest. They wished to identify manufacturing sites, logistic operations, distribution network, salesforce assessment and their sales targets.