Formulation Development
VACCINE DEVELOPMENT - Enhancing Pandemic Preparedness With Mosaic-8b Nanoparticles
Leonardo Magneschi, PhD, says although the mosaic-8b vaccine is still in early development, it has the potential to enable a broad and cross-reactive immunization strategy that could provide comprehensive protection against known and unknown sarbecoviruses.
OUTSOURCING PHARMA DEVELOPMENT - Harnessing CDMOs for Innovation & Efficiency
Rohtash Kumar, PhD, says a strategic partnership with a trusted CDMO can provide many benefits ranging from experts’ insights to state-of-the-art equipment. However, there are several considerations that developers should evaluate prior to engaging with a CDMO to maximize their partnership.
NEW PRODUCT INTRODUCTION - Addressing the Pitfalls of Progressing From Pilot to Product Through Effective New Product Introduction
Uwe Hanenberg, PhD, Wolfram Bühler, and Radoslaw Kaczanowski, PhD, explore the risks and challenges pharmaceutical companies face when undertaking NPI to ensure new products successfully reach the market and patients and examine the strategies CDMOs are adopting to ensure the smooth delivery of these projects from discovery to commercialization.
CELL SEPARATION TECHNOLOGY - Breaking Down Barriers to Unlock a New Era of Cell Therapy
Dr. Liping Yu believes revolutionary cell separation technologies are crucial for enabling these rapid advancements, and will continue to play a growing role in establishing the decentralized, rapid, and cost-effective large-scale manufacture of potentially life-saving cell-based drugs well into the future.
FOCUSED ULTRASOUND - Overcoming Drug Delivery Challenges
Neal F. Kassell, MD, says one promising approach, focused ultrasound (FUS), is emerging as a revolutionary tool, enabling non-invasive, targeted BBB disruption. This method holds transformative potential in delivering therapies for neurodegenerative diseases and other challenging conditions, setting the stage for novel treatments in the years ahead.
Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer & Plans for FDA Alignment on Next-Stage Development
Ocean Biomedical recently announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI),…
Safi Biotherapeutics & ARMI BioFabUSA Initiate Collaboration to Support Large-Scale Development of mRBCs
Safi Biotherapeutics recently announced a collaboration focused on the manufacturing of Safi’s mRBCs to support regulatory requirements and initial clinical studies. “We are very excited…
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Biodexa Pharmaceuticals PLC recently announced the US FDA has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the…
Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale & Clinical Supply
Recipharm recently announced a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its…
Alumis & ACELYRIN to Merge Creating a Late-Stage Clinical Biopharma Company
Alumis Inc. and ACELYRIN, INC. recently announced a definitive merger agreement under which Alumis and ACELYRIN will merge in an all-stock transaction. Martin Babler, President,…
Conduit Pharmaceuticals Transitions to Phase 2 of Sarborg Collaboration to Support AI-Driven Drug Development
Conduit Pharmaceuticals Inc. recently announced the successful completion of all milestones in Phase 1 of its strategic collaboration with Sarborg Limited. This transition to Phase…
Maze Therapeutics Doses First Patient in Phase 2 Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease
Maze Therapeutics, Inc. recently announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients…
Thermo Fisher Scientific Launches International CorEvitas Clinical Registry in Adolescent Alopecia Areata
Thermo Fisher Scientific Inc. recently announced the launch of the international CorEvitas Adolescent Alopecia Areata (AA) Registry, addressing a critical unmet need for real-world, adolescent-specific…
Gradalis Secures FDA Regenerative Medicine Advanced Therapy Designation for Investigational Personalized Immunotherapy for Advanced Ovarian Cancer
Gradalis, Inc. recently announced the US FDA has granted Gradalis’ personalized investigational cellular immunotherapy, Vigil (Gemogenovatucel-T) Regenerative Medicine Advanced Therapy (RMAT) designation based on favorable clinical…
Indaptus Therapeutics Receives Approval From Health Canada to Expand Clinical Trial of Decoy20
Indaptus Therapeutics, Inc. recently announced it has received Clinical Trial Authorization from Health Canada to initiate its clinical trial for its lead asset, Decoy20. This…
Annovis Announces First Patients Entered Into Pivotal Phase 3 Study of Buntanetap for Early Alzheimer’s Disease
Annovis Bio Inc. recently announced the first two patients have been entered into the pivotal Phase 3 study evaluating buntanetap in early AD. "The launch…
Quantum Biopharma Announces the Success of unbuzzd Clinical Trial
Quantum BioPharma Ltd. recently announced it has completed a double-blind, randomized, placebo-controlled crossover design clinical trial (NCT06505239) of its dietary supplement product unbuzzd, investigating its…
Gelteq Launches SportsGel Brand & Signs Distribution Agreement With E-Commerce Solutions Company
Gelteq Limited recently announced the launch of its SportsGel brand. “SportsGel has been established to eliminate the common trade-off between performance versus taste, mouthfeel and…
Ardena Completes Acquisition of Advanced Drug Product Manufacturing Facility From Catalent & Expands Bioanalytical Services in North America
Ardena recently announced it has successfully completed the acquisition of Catalent’s state-of-the-art drug product manufacturing facility in Somerset, NJ. This acquisition marks a significant milestone…
Northstrive Biosciences Reports Positive Updates for Obesity Drug Candidates
Northstrive Biosciences Inc. recently announced an update for its innovative obesity treatment candidates, EL-22 and EL-32, both aimed at optimizing fat loss while preserving muscle…
