Formulation Development
LYOPHILIZATION - Lyo 101: Challenges & Solutions in Lyophilization Cycle Development
Matt Bourassa says as companies continue to pioneer new molecules and treatments, molecule stability has emerged as a persistent detriment to every iteration, and increasingly, lyophilization is an attractive path to a sustainable, repeatable solution.
FORMULATION DEVELOPMENT - Practical & Purposeful: Creating Novel Compounds Via Rediscovery R&D & Cannabinoid Molecules
Mark Bleackley, PhD, says as time goes on, more companies will discover the benefits of drug repurposing – and how to successfully use such strategies to develop new, patentable drug products. In fact, repurposing could be exactly what’s needed to enable pharmaceutical and biotechnology companies to more swiftly develop treatments for indications with significant unmet medical needs.
SMI TECHNOLOGY - How Soft Mist Inhalers Support Improved Biopharma Drug Delivery
Nicolas Buchmann, PhD, explores the opportunities and challenges of developing biologic formulations for delivery via SMIs and discusses the importance and impact of partnerships between inhalation device development experts when it comes to facilitating the innovation needed to expand the suitability of SMIs to a wider range of biopharma formulations.
PRECLINICAL/CLINICAL STUDIES - Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-Based Formulations
Anette Müllertz, PhD, Grace Furman, PhD, and Lisa Caralli say developers should first understand the developability challenges for their molecule, then a toolkit of enabling technologies can be identified to overcome those factors and individually leveraged to create fit for purpose formulations for use in preclinical and clinical studies.
PLATFORM TECHNOLOGY - Developing Novel Antisense Oligonucleotides for Neurodegenerative Diseases
Scott Schobel, MD, and Nicole Datson, PhD, are hopeful their novel platform for targeting disease-causing RNA with multiple modulating approaches will lead to major advances in treating genetic disease and improving the lives of patients and their families in the years ahead.
Abzena Expands Partnership With ProteoNic to Include 2G UNic Technology as Standard Offering for All Customers
ProteoNic recently announce an expanded partnership with Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates. Following the successful launch of AbZelectPRO, a high-producing…
Recipharm & Exela Announce Exclusive Strategic Alliance
Recipharm and Exela Pharma Sciences recently announced their exclusive strategic alliance aimed at enhancing sterile manufacturing capabilities in the US. This collaboration will provide Recipharm…
Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH
Sagimet Biosciences Inc. recently announced the US FDA granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to…
BriaCell Reports 100% Resolution of Brain Metastasis in Breast Cancer Patient With “Eye-Bulging” Tumor
BriaCell Therapeutics Corp. reports significant anti-tumor response including complete resolution of temporal lobe breast cancer metastasis in a patient treated in the Phase 2 study…
Barinthus Bio Completes Enrollment for Phase 2b Trial in Chronic Hepatitis B & Phase 1 Trial in Prostate Cancer
Barinthus Biotherapeutics plc recently announced the completion of enrollment for two clinical trials: HBV003, a Phase 2b clinical trial of VTP-300 in adults with chronic…
Ocean Biomedical Announces New Data Deepening Understanding of Novel Cancer Immunotherapy Treatment Approach
Ocean Biomedical recently announced Scientific Co-founder Dr. Jack A. Elias, MD, PhD, and colleagues have published new research in the Journal of Immunology that expands…
Sermonix Pharmaceuticals’ Lasofoxifene Demonstrates Anti-Estrogen Therapy Increases Immunotherapy Efficacy by Promoting Antitumor Activity of Eosinophils
Sermonix Pharmaceuticals Inc. recently announced its lead investigational drug, lasofoxifene, was featured in a new Duke Cancer Institute study revealing that anti-estrogen therapy increases the…
Tessellate BIO, Omico & CMRI Announce Multi-Year Collaboration
Tessellate BIO recently announced a collaboration with CMRI and Omico to advance the understanding of the prevalence of alternative lengthening of telomeres (ALT) across tumor…
Renaissance Lakewood Supports ARS Pharmaceuticals’ Launch of World’s First Nasal Spray for Life-Threatening Allergies
Renaissance Lakewood, LLC is proud to be manufacturing neffy, which is now commercially available in the US. On August 9, 2024, the US FDA approved ARS…
Prime Medicine Announces Strategic Research Collaboration & License Agreement With Bristol Myers Squibb
Prime Medicine, Inc. recently announced a strategic research collaboration and license agreement with Bristol Myers Squibb to develop reagents for the next generation of ex…
Enliven Therapeutics Announces Positive Data Update from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia
Enliven Therapeutics, Inc. recently announced updated, positive data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) that has…
Traws Pharma Announces Positive Topline Phase 1 Results for COVID Candidate, an Oral Mpro Inhibitor
Traws Pharma, Inc. recently announced positive topline Phase 1 results for its potential best-in-class COVID (SARS-CoV-2) candidate, ratutrelvir, an oral inhibitor of the Main protease…
Adaptive Research Announces it has Begun Enrolling Patients in AriBio’s Phase 3 POLARIS-AD Clinical Trial
Adaptive Research recently announced two community practices that are part of the Adaptive Research network have begun patient enrollment and randomization in AriBio’s Phase 3, Double-blind,…
Ocuphire Pharma Announces Full Phase 3 Results of Phentolamine Ophthalmic Solution for Pharmacologically Induced Mydriasis in Ophthalmology
Ocuphire Pharma, Inc. recently announced the publication of full results from two pivotal Phase 3 clinical trials (MIRA-2 and MIRA-3) that evaluated the safety and…
GRI Bio Granted Patent for Proprietary Natural Killer T Cell Modulators for Prevention & Treatment of Inflammatory Conditions
GRI Bio, Inc. recently announced it has received a Decision to Grant notice from the Japan Patent Office (JPO) for the patent application No. 2023-000750…
