Formulation Development
Shape Therapeutics Shares Breakthrough Preclinical Data for Non-Invasive Treatment of Parkinson’s Disease Using a Brain Targeted AAV Gene Therapy
Shape Therapeutics recently announced it presented new preclinical data highlighting the therapeutic potential of its lead product (SHP-201), a disease-modifying gene therapy for the treatment…
AviadoBio & UgeneX Therapeutics Announce Exclusive Option-License Agreement to Develop Next Generation Optogenetics Gene Therapy to Restore Vision in Patients With Retinal Disease
AviadoBio Ltd. and UgeneX Therapeutics, today announced an exclusive option and license agreement for the development and commercialization of UGX-202, an investigational, AAV-based gene therapy…
Ligand Partner SQ Innovation Receives FDA Approval for Lasix ONYU, an At-Home Treatment for Edema in Heart Failure Patients
Ligand Pharmaceuticals Incorporated recently announced that its partner SQ Innovation Inc. has received approval from the US FDA for Lasix ONYU (furosemide injection), a novel…
New Preclinical Data From Encoded Therapeutics Demonstrate Therapeutic Potential of its One-time, Non-opioid Gene Therapy Candidate for Chronic Pain
Encoded Therapeutics Inc. recently announced preclinical data demonstrating that its AAV9 microRNA (miRNA) gene therapy candidate achieved robust knockdown of SCN9A (NaV1.7), a key mediator of…
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.
