Formulation Development
Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics recently announced it has received authorization from the European Medicines Agency (EMA) to initiate the Company’s Phase 2 RENEW clinical trial of its…
Gelteq Announces New Product Development Agreement With Melbourne Health for Novel Bowel Polyp Growth Reduction Compound
Gelteq Limited recently announced it has entered into a Product Development and Profit Share Agreement with Melbourne Health, operator of The Royal Melbourne Hospital and…
Annovis Announces Novel Biomarker Data in Alzheimer’s Patients Supporting Buntanetap’s Potential as a Disease-Modifying Treatment
Annovis Bio, Inc. recently announced new results that demonstrate buntanetap’s ability to attenuate inflammation and improve cellular health in Alzheimer’s patients, suggesting potential disease-modifying effects…
Roquette Boosts Extensive Cyclodextrins Portfolio With Launch of KLEPTOSE® Crysmeb methyl-beta-cyclodextrin for Oral & Parenteral Formulations
Roquette, a global leader in plant-based ingredients and pharmaceutical excipients for the health and nutrition sectors, recently launched of its latest novel pharmaceutical excipient: KLEPTOSE®…
Zenas BioPharma & InnoCare Pharma Announce License Agreement Granting Zenas Rights for Three Autoimmune Product Candidates, Including Orelabrutinib, a BTK Inhibitor in Phase 3 Development for Multiple Sclerosis
Zenas BioPharma, Inc. and InnoCare Pharma Limited recently announced a transformational license agreement granting Zenas global development and commercialization rights to orelabrutinib for Multiple Sclerosis…
Complement Therapeutics Receives FDA IND Clearance to Advance CTx001 Into Opti-GAIN, a Phase I/II Clinical Trial in Geographic Atrophy Secondary to AMD
Complement Therapeutics GmbH (CTx), a biotechnology company developing next-generation therapeutics for complement-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared…
Rigel Announces First Patient Enrolled in the Dose Expansion Phase of its Phase 1b Study of R289 in Patients With Lower-Risk MDS
Rigel Pharmaceuticals, Inc. recently announced the first patient has been enrolled in the dose expansion phase of the ongoing Phase 1b study of R289 in…
Lisata Therapeutics & Catalent Announce Global Antibody-Drug Conjugate License Agreement
Lisata Therapeutics, Inc. and Catalent, Inc. recently announced a global product license agreement that allows Catalent to incorporate Lisata’s certepetide into antibody-drug conjugates (ADCs) developed…
Nutriband Files Provisional Patent Application for Enhanced Transdermal Abuse Deterrent Technology
Nutriband Inc. recently announced that it has filed a provisional patent application with the US Patent and Trademark Office (USPTO) to further strengthen Nutriband’s intellectual…
NurExone Demonstrates Reproducible, Dose-Dependent Vision Recovery in Preclinical Glaucoma Model
NurExone Biologic Inc. recently announced new preclinical results showing that its lead candidate ExoPTEN produces a reproducible, dose-dependent therapeutic effect in an eye model of glaucoma.…
CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm
John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
FORMULATION FORUM - Orally Disintegrating Tablets
Shaukat Ali, PhD, and Jim Huang, PhD, say as more NCEs are being discovered, the industry is weighing all options for evaluating those molecules in different dosages to improve solubility and oral bioavailability. With requirement for taste-masking of bitter drugs with commercially available ODT excipients, it poses additional challenges for improving taste-masking and performance of molecules for the intended usages.
PRECLINICAL SCREENING PLATFORM - From Preclinical Screening to Clinical Optimization: Accelerating Poorly Soluble Drug Development
Andrew Parker, PhD, John McDermott, and Sandeep Kumar, PhD, believe the development of poorly soluble drugs remains a significant challenge in pharmaceutical R&D. However, by adopting an adaptive approach that integrates services from preclinical screening to clinical optimization, developers can achieve significant time- and cost-saving benefits.
LIPID FORMULATION DEVELOPMENT - Why Softgels Are the Technology of Choice
Dipanwita De, PhD, and Kaspar van den Dries say solubility and bioavailability in OSD formulations remain major challenges within the early stages of drug development. While technological innovations have allowed the pharmaceutical industry to make progress in solving this hurdle, choosing formulations that help achieve desirable solubility and bioavailability can help speed up development of the most promising molecules.
EXCIPIENT TECHNOLOGY - Driving Oral Drug Delivery Innovation With Safe, Reliable Lipid Excipients
Nick DiFranco, MEM, says amidst the uncertainty of novel ingredients and formulation techniques, lipid excipients provide a safe, proven platform for enhancing in vivo formulation performance, enabling innovation without sacrificing scalability or regulatory confidence.
CLINICAL TRIALS - Keeping Pace With Shifting Drug Development Paradigms for Multi-Indication Therapies
Simon Bruce, MD, and Jack L. Martin, MD, indicate that as developers increasingly embrace multi-indication development, the success of multi-indication therapies will stem not merely from pipeline adjustments, but also from development strategies designed with multi-indication objectives at their core.
EXECUTIVE INTERVIEW - Intensity Therapeutics: Providing Cancer Patients With Treatments That Work
Lew Bender, Founder and CEO of Intensity Therapeutics, discusses the company’s science, clinical program, the drug development process, and more.
Salipro Biotech Strengthens Global IP Portfolio With Two New Patents
Salipro Biotech AB recently announced the issuance of two new patents by the Japanese Patent Office. These patents further solidify the company’s intellectual property (IP)…
Resalis Therapeutics Reports Durable, Fat-Selective Weight Loss With RES-010 in Non-Human Primates
Resalis Therapeutics recently presented new preclinical results on its lead candidate RES-010, a first-in-class antisense oligonucleotide targeting microRNA-22 (miR-22). The data was presented at the European…
