Press Releases
NeuroGT Announces FDA Clearance of Investigational New Drug Application for NGT-104, an AAV9 Gene Replacement Product for MPS IIIB | BioPharma Dive
NeuroGT, a clinical-stage gene therapy company, announced that the U.S. FDA has cleared the IND application for NGT-104. NGT-104 is an AAV9 gene replacement product intended for the treatment of MPS IIIB (Sanfilippo syndrome type B). The approved Phase I/II human clinical trial is expected to begin patient enrollment in January 2027.
TSRL Secures Second-Year NIH Award to Advance Microneedle Patch for Overactive Bladder Treatment
TSRL, Inc., a preclinical CRO based in Ann Arbor, Michigan, announced it has received its second-year Notice of Award from the NIH (Grant Number 5R44DK143799-03) to advance its microneedle patch delivering Trospium Chloride for overactive bladder. The nearly $1.1 million in continued funding supports preclinical development including pharmacokinetics, efficacy, safety, and formulation optimization. Principal Investigator Dr. Elke Lipka emphasized the importance of continued support amid funding uncertainties and the potential of the platform to improve patient adherence and tolerability.
Toralgen Demonstrates Oral Delivery Across Multiple Diabesity Peptide Classes, Advancing the Potential of Oral Biologics | BioPharma Dive
On August 4, 2026, Toralgen announced that its proprietary polymeric ursodeoxycholic acid (pUDCA) nanoparticle platform achieved successful oral delivery of multiple diabetes/obesity peptide drugs, including mono-agonists, dual-agonists, and tri-agonists. Research conducted in collaboration with bioanalytical CRO Veloxity Labs showed that a single nanoparticle formulation can deliver multiple peptide drugs without requiring peptide-specific optimization. Preliminary studies of semaglutide demonstrated a relative bioavailability of approximately 7%, with oral exposure 5-10 times higher than the commercial SNAC formulation, and minimal food effects (<20%). These results were presented at the American Diabetes Association's 85th Scientific Sessions.
Schrödinger Announces Strategic Collaboration and Software Agreement with Bristol Myers Squibb to Deploy AI Co-Scientist Bunsen | BioPharma Dive
Schrödinger, Inc. (Nasdaq: SDGR) announced on August 5, 2026, a strategic agreement with Bristol Myers Squibb (BMS) to deploy its agentic AI co-scientist Bunsen within BMS research organizations. Building on the companies' long-standing collaboration, the agreement significantly expands the application of Schrödinger's computational platform, aiming to help BMS scientists explore more scientific possibilities, prioritize molecules with greater confidence, and accelerate discovery decisions.
European Consortium Develops Transformative Manufacturing Model for Pharmaceuticals Ingredients | BioPharma Dive
The European Union announced the completion of a pilot project validating a continuous manufacturing platform for active pharmaceutical ingredients, which integrates continuous flow chemistry, AI monitoring, and real-time analysis, and successfully produced fentanyl, offering a new pathway for future pharmaceutical production.
Greenstone Biosciences Receives NIH R61 Grant to Advance Cardiac Fibrosis Therapeutics for Duchenne Muscular Dystrophy | BioPharma Dive
On August 7, 2026, Greenstone Biosciences announced receipt of a Catalyze R61 grant from NHLBI to discover novel drug candidates for myocardial fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy (DMD). The project will combine iPSC disease models, proteomics, computational screening, and generative AI; if the R61 phase is successful, it will advance to the R33 phase for in vivo testing.
Kivo to Showcase Headless GxP at RAPS Convergence 2026 | BioPharma Dive
Kivo announced its participation at RAPS Convergence 2026, scheduled for September 15-17 in Charlotte, N.C. The company will demonstrate Kivo Headless GxP at Booth #706, highlighting how AI agents can work alongside humans in regulated environments.
Greenstone Biosciences Awarded Breakthrough T1D Grant to Advance Type 1 Diabetes (T1D)-Derived Islet Cell Platform for Research and Development | BioPharma Dive
Greenstone Biosciences has received a grant from Breakthrough T1D to construct 3D islet organoids using patient-derived iPSCs, integrate multi-omics technologies to investigate mechanisms of beta cell damage in T1D, and establish a shareable cell resource repository.
Bermoxel® (Praziquantel 600 mg) Now Available Across All 27 EU Member States Amid Restricted Biltricide® Availability | BioPharma Dive
Amid supply restrictions of Biltricide®, Medochemie's Bermoxel® (praziquantel 600 mg) is now available across all 27 EU member states. Manufactured by Medochemie, it is the only locally authorized supplier of praziquantel 600 mg tablets in Europe. The supply network covers Germany, Austria, the Netherlands, Belgium, Luxembourg, Greece, Cyprus, and 20 other member states.
Healthcare Delivery Enters a New Era as Prefilled Syringes Gain Industry Attention | BioPharma Dive
Prefilled syringes are becoming an important innovation direction in medical drug delivery due to standardized dosing, simplified administration processes, and reduced preparation steps. Based on information released in August 2026, this article analyzes their role in patient safety, clinical efficiency, pharmaceutical packaging and manufacturing, and future development trends.