World Pharmaceutical Frontiers

🟢 Iterum Therapeutics plc has received FDA approval for Orlynvah (sulopenem etzadroxil and probenecid), an oral penem antibiotic designed to treat uncomplicated urinary tract infections (uUTIs) in adult women. This approval is significant as Orlynvah targets infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in cases where few or no alternative oral treatments are available. 📊 Originally declined by the FDA in 2021 due to a need for additional data, Iterum re-submitted its application following successful late-stage trials that confirmed Orlynvah’s safety and tolerability. Key trials, SURE 1 and REASSURE, demonstrated the drug’s efficacy, with SURE 1 showing its effectiveness over ciprofloxacin for fluoroquinolone-resistant infections, and REASSURE establishing its non-inferiority and statistical superiority to Augmentin in certain patients. 💊 Orlynvah is the first oral penem antibiotic approved in the US, making it a crucial alternative for the underserved uUTI market. Iterum CEO Corey Fishman highlighted its role in combating antimicrobial resistance and announced plans for a strategic transaction to maximize the drug's value for stakeholders. Commercial launch is anticipated around mid-2025. 🔬 Orlynvah is now only the second FDA-approved oral therapy for uUTIs in over twenty years, providing new hope for patients facing limited treatment options. #FDAApproval #Orlynvah #IterumTherapeutics #UTITreatment #AntibioticResistance #PharmaNews #InfectiousDisease #WomenHealth #Biotech

🧬 Dyno Therapeutics has announced a new partnership with Roche valued at up to $1.05 billion to develop next-generation AAV gene therapy vectors targeting neurological diseases. Utilizing Dyno’s AI-powered platform, the collaboration aims to overcome key challenges in AAV gene therapy, including delivery efficiency, immunity issues, and manufacturability. The advanced AAV capsids will be tailored specifically for neurological applications, marking a step forward in effective in vivo gene delivery. 💰 The deal provides Dyno with an initial $50 million payment, and includes additional milestone payments and royalties. This marks the second partnership between the companies, following a 2020 collaboration for neurological and liver therapies. 🧪 Dyno’s Low-Shot Efficient Accelerated Performance (LEAP) technology enables billions of in vivo sequence-function measurements each month, allowing rapid optimization of AAV capsids for specific tissue targeting. Under the new agreement, Dyno will lead in designing and discovering enhanced AAV capsids, while Roche will focus on preclinical and clinical validation, as well as commercialization of neurological gene therapies using these novel vectors. 🧠 Roche’s business development lead, Boris L. Zaïtra, highlighted the importance of the partnership, noting that combining Roche’s therapeutic expertise with Dyno’s advanced capsid engineering opens up opportunities for tackling historically difficult-to-treat neurological diseases. #GeneTherapy #Neurology #DynoTherapeutics #Roche #AAVVectors #BiotechInnovation #AIinBiopharma #PrecisionMedicine #NeurologicalTherapies #BiopharmaPartnership

🚀 Roche Bets Big on the Future of Gene Therapy Delivery 🚀 Roche is making a significant move in the gene therapy space with a new partnership with Dyno Therapeutics, worth over $1 billion. The goal? To solve one of gene therapy’s biggest challenges: delivery. Gene therapies hold incredible potential by addressing the root cause of inherited diseases, but getting the treatment to the right cells remains a hurdle. Dyno's AI-driven technology is aiming to change that by designing more efficient ways to deliver therapies, especially for neurological diseases. 💡 The collaboration builds on a previous agreement and gives Roche access to breakthrough technology that could lead to treatments for difficult-to-treat conditions like Alzheimer's disease. With this partnership, Roche continues to push the boundaries of what’s possible in medicine, ensuring that gene therapies reach their full potential and improve lives. #GeneTherapy #Roche #Biotech #DynoTherapeutics #NeurologicalDiseases #HealthcareInnovation #AI

🤝 Charles River Laboratories and FibroBiologics (Nasdaq: FBLG) have signed a master services agreement to produce therapeutic cell banks and CYWC628, a fibroblast-based product. These products will be used in a diabetic foot ulcer (DFU) clinical trial, set to begin in 2025. 🧫 FibroBiologics is a clinical-stage biotechnology company developing treatments for chronic diseases using fibroblasts and fibroblast-derived materials. The company holds more than 160 patents issued and pending for these therapeutics. 🔬 FibroBiologics is exploring the use of fibroblasts' immunomodulatory and regenerative properties to treat conditions like wound healing, multiple sclerosis, degenerative disc disease, psoriasis, thymic involution reversal, and cancer. 💡 CEO Pete O'Heeron of FibroBiologics highlighted the importance of this partnership with Charles River, emphasizing the potential to scale and innovate with Charles River’s global expertise. This collaboration is a key step towards their wound care clinical trial with CYWC628. ⚙️ Charles River will serve as the contract development and manufacturing organization (CDMO) for the clinical trial, producing the necessary drug products under current good manufacturing practices (CGMP). 🌍 Kerstin Dolph, Charles River’s senior vice president, expressed excitement about supporting next-generation regenerative medicine through innovative therapies like CYWC628, aiming to improve care for patients with diabetic foot wounds. 📅 This partnership follows earlier feasibility studies on FibroBiologics' cell manufacturing processes, which yielded positive results, and the companies have already completed technology transfer for production. #Biotechnology #Fibroblasts #RegenerativeMedicine #ClinicalTrials #DiabeticFootUlcers #WoundCare #PharmaInnovation #CDMO #HealthcareTransformation #MedicalResearch #CellTherapy #DrugDevelopment #Biopharma

📢 Astellas Pharma has received FDA approval for its monoclonal antibody therapy Vyloy (zolbetuximab-clzb), in combination with chemotherapy, to treat certain types of gastric or gastroesophageal junction (GEJ) cancer. This treatment is specifically for HER2-negative gastric or GEJ adenocarcinoma patients whose tumors express CLDN18.2, a key transmembrane protein. 🧬 Vyloy is a cytolytic monoclonal antibody (mAb) that targets and depletes CLDN18.2-positive cancer cells. The treatment is combined with fluoropyrimidine- and platinum-based chemotherapy and is indicated for locally advanced gastric or GEJ cancer. 🤝 Astellas partnered with Roche to provide a companion diagnostic test, VENTANA CLDN18 (43-14A) RxDx Assay, which identifies patients eligible for Vyloy treatment. This collaboration helps ensure the right patients receive the therapy, enhancing treatment precision. 📊 FDA approval is based on positive results from two Phase 3 clinical trials: SPOTLIGHT and GLOW, which demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) for patients with CLDN18.2-positive tumors. 🌍 Global Reach: Vyloy is now approved in five major markets: Japan, the UK, the EU, South Korea, and the US. This approval marks a significant milestone as Vyloy is the first and only CLDN18.2-targeted therapy available in the US. 💡 Astellas continues to innovate in immuno-oncology, offering new hope for patients with limited treatment options in gastric and GEJ cancers. The company is pushing the boundaries of science to bring life-saving treatments to patients in need.

🚨 **FDA Grants Priority Review to GSK’s Gepotidacin for UTI Treatment!** 🚨 GSK has announced that the US FDA has accepted the New Drug Application (NDA) for its investigational oral antibiotic, **gepotidacin**, to treat uncomplicated urinary tract infections (uUTIs) in adult and adolescent women. In a major milestone, the FDA has granted **Priority Review**, with a decision expected by **March 26, 2025**. This NDA is backed by the promising results from the Phase 3 **EAGLE-2** and **EAGLE-3** trials, which demonstrated that gepotidacin is **non-inferior** to nitrofurantoin, the current standard of care for uUTIs. Impressively, in the EAGLE-3 trial, gepotidacin showed **statistical superiority**, achieving a 58.5% success rate compared to 43.6% for nitrofurantoin. With this new treatment option on the horizon, GSK continues to advance innovation in antibiotic therapies, addressing the growing need for alternatives in treating uUTIs. #FDAApproval #GSK #UTITreatment #PharmaNews #Gepotidacin #Antibiotics #PriorityReview #HealthcareInnovation #ClinicalTrials

🌟 Promising Phase 3 Results for Zepzelca in Lung Cancer Treatment 🌟 Exciting news from Jazz Pharmaceuticals! The combination of Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) has demonstrated significant improvements in both overall survival (OS) and progression-free survival (PFS) in a Phase 3 trial for patients with extensive-stage small cell lung cancer (ES-SCLC). This marks a significant advance for patients receiving first-line maintenance therapy. The IMforte study compared Zepzelca plus atezolizumab to atezolizumab alone, showing a statistically significant benefit in delaying disease progression and extending survival. The combination was generally well-tolerated, with no new safety concerns. With these results, Jazz plans to submit a supplemental New Drug Application (sNDA) in the first half of 2025. This progress is a crucial step forward in offering more effective treatment options for those battling this aggressive cancer. A special thank you to all the investigators, patients, and partners involved in this critical trial. Together, we are making strides towards better outcomes in lung cancer care. #LungCancer #Oncology #ClinicalTrials #PharmaceuticalInnovation #CancerResearch #JazzPharma #Roche

💊 Lundbeck to Acquire Longboard Pharma for $2.6bn 💊 Danish pharmaceutical company Lundbeck has announced its agreement to acquire Longboard Pharmaceuticals, a U.S.-based biopharmaceutical company, for a total equity value of around $2.6 billion. 💡 Deal Highlights: Lundbeck will launch a tender offer to purchase all outstanding shares of Longboard common stock at $60 per share in cash, representing a 77% premium over the 30-day volume-weighted average price (VWAP) of Longboard’s shares as of September 30, 2024. 🧠 Strategic Acquisition: This acquisition will be pivotal for Lundbeck’s neuro-rare franchise, with bexicaserin, Longboard’s lead candidate, at the core. Bexicaserin is a novel 5-HT2C agonist being developed to treat seizures associated with Developmental and Epileptic Encephalopathies (DEEs), and is currently in a Phase 3 DEEp SEA study for Dravet syndrome. 📈 Growth Potential: Lundbeck’s President and CEO, Charl van Zyl, described the deal as transformative, addressing a critical unmet need for rare epilepsies, where treatment options are limited. With this acquisition, Lundbeck aims to continue its Focused Innovator strategy and solidify its expertise in rare brain disorders. 🌍 Longboard’s Contribution: Longboard Pharma focuses on neurological diseases and has achieved groundbreaking data for treating rare epilepsies. The acquisition also allows Lundbeck to access treatments for a wide range of DEEs, including Dravet syndrome, Lennox-Gastaut syndrome, and other severe forms of epilepsy. 🔜 Closing Timeline: The deal is expected to close by the fourth quarter of 2024, pending regulatory approval and the successful tender of Longboard’s majority voting shares. #Lundbeck #LongboardPharma #Bexicaserin #NeuroRareFranchise #EpilepsyTreatment #DEEs #PharmaceuticalIndustry #Biotech #SeizureTreatment #MergersAndAcquisitions #DravetSyndrome #LennoxGastaut

🚀 EVERSANA Expands Drug Safety Offering with Oracle Argus Cloud 🚀 EVERSANA, a leading US-based commercial services provider in the life sciences industry, has announced a significant expansion of its pharmacovigilance and drug safety capabilities through a new partnership with Oracle Argus Cloud. 🧠 AI-Powered Automation: Oracle Argus Cloud brings advanced AI-driven automation, workflow optimization, and touchless processing to handle increasing pharmacovigilance caseloads and adapt to evolving regulatory requirements. This collaboration will allow EVERSANA to streamline drug safety management while ensuring patient safety. 🌐 Global Expansion: EVERSANA, a member of the Oracle Partner Network since 2023, has been promoted by Oracle for global pharmacovigilance and implementation services. Several of EVERSANA’s clients have already migrated to the Oracle platform, with future clients set to benefit from the comprehensive drug safety system. 🗣️ Leadership Perspective: CEO Jim Lang emphasized that the collaboration is driven by innovation and transformational thinking, combining EVERSANA’s experience with Oracle’s leading systems to prioritize patient safety. 🌍 Global Medical Information Hub: EVERSANA has also rapidly expanded its global medical information contact center, offering multi-language support 24/7 across regional hubs in North America, Europe, India, and Japan. These hubs ensure that patients, clinicians, and caregivers have access to the latest therapy information and can report adverse effects in their native languages. #EVERSANA #OracleArgusCloud #DrugSafety #Pharmacovigilance #LifeSciences #AIinHealthcare #PharmaceuticalInnovation #PatientSafety #GlobalExpansion #MedicalInformation #HealthcareTechnology

🚀 Exciting Collaboration Alert! 🚀 Eli Lilly and Company and insitro have partnered to tackle metabolic diseases through innovative drug development. This strategic alliance will leverage insitro's AI/ML capabilities to identify targets for new therapies, including treatments for metabolic dysfunction-associated steatotic liver disease (MASLD). Key highlights: - The collaboration combines insitro’s cutting-edge machine learning platforms with Lilly’s expertise in drug delivery and metabolic biology. - Insitro will lead the development of new drugs, utilizing Lilly’s clinical-stage GalNAc delivery technology alongside its proprietary siRNA molecules. - A third agreement focuses on jointly discovering an antibody for a novel metabolic disease target. Insitro’s, emphasizes the transformative potential of this partnership, which aims to address metabolic diseases at their core. With insitro retaining global rights and Lilly benefiting from potential milestones and royalties, this collaboration is poised to make a significant impact in the field. Stay tuned for updates as they advance their promising pipeline! #Biotech #Pharma #Collaboration #DrugDevelopment #AI #MachineLearning #MetabolicDiseases