Formulation Development
Veru Receives FDA Agreement to Advance VERU-111 Into Phase 3 Study
Veru Inc. recently announced the FDA agreed in an End of Phase 2 meeting, to advance VERU-111 into a Phase 3 registration clinical study based on the clinically meaningful benefits observed with….
LEXEO Therapeutics Announces License Agreement & Consolidation of Comprehensive Preclinical Data Package
LEXEO Therapeutics recently announced it has licensed worldwide intellectual property rights and preclinical data from Adverum Biotechnologies to its….
Qualigen Therapeutics Secures Option to Negotiate License for G-Quadruplex Anti-Cancer Technology
Qualigen Therapeutics, Inc. recently announced it has entered into a Material Evaluation and Option Agreement with the University College London (UCL) to advance development of…
VYNE Therapeutics Announces Development Program for Combination Topical Gel
VYNE Therapeutics Inc. recently announced development plans for FMX114, a fixed combination of pan-JAK inhibitor tofacitinib and sphingosine 1-phosphate receptor modulator fingolimod in a topical…
Silo Pharma Enters Exclusive Option Agreement With the University of Maryland
Silo Pharma, Inc. recently announced it has executed an exclusive option agreement with the University of Maryland, Baltimore to explore a novel invention generally known…
NGM Bio Initiates Expansion of Ongoing Phase 1b Proof-of-Concept Study
NGM Biopharmaceuticals, Inc. recently announced it has dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients…
Aptamer Group Extends Collaboration With AstraZeneca to Explore Next-Generation Drug Delivery Approaches
Aptamer Group, the developer of Optimer reagents and therapeutics, recently announced the extension of its current agreement with AstraZeneca, a global biopharmaceutical company. This agreement…
SPECIAL FEATURE - Improving Bioavailability & Solubility: Each Molecule Is Unique
Contributor Cindy H. Dubin speaks with several innovative companies to discuss novel approaches to improving bioavailability and solubility that have one commonality: they treat each molecule as an individual.
FORMULATION FORUM - Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
GLOBAL REPORT - 2020 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2020 product approvals.
CELL & GENE THERAPY - End-to-End Cell & Gene Therapy – From Development to Commercialization – Buy or Build?
Aldo Romano and Emily Moran, MBA, discuss how the life science industry must bring technology solutions to the table while at the same time securing the capacity to develop and manufacture groundbreaking cures so patients and society can tap the benefits of cell and gene therapies.
DRUG DEVELOPMENT - Understanding & Targeting the Mechanism of Action of Developmental Disorders
Michael Snape, PhD, says when identifying promising therapeutic targets for any disease or condition, including developmental disorders such as Fragile X syndrome, PMS, CDM1, and Rett syndrome, it is critical researchers work to understand the mechanism of disease and disease pathways as well as the unmet need and patient experience.
EXECUTIVE INTERVIEW - Pharmaceutics International, Inc: Getting Back to its Roots
Sridhar Krishnan, Pii’s Senior Vice President, Operations and Strategic Initiatives, discusses how manufacturing is not solely where Pii wanted to be, so the company made a concerted effort to get back to its CDMO roots.
IMMUNE ACTIVATORS - Enhancing Cell Adhesion to Safely Improve Effectiveness of Vaccines & Cancer Immunotherapies
Siddhartha De, PhD, and Peter Vanderslice, PhD, present their research on the use of proprietary, orally available compounds that can activate the immune system to enhance the effectiveness of vaccines as well as immuno-oncology therapies for cancer, especially in patient populations that are most vulnerable to disease.
MICROFLUIDIC ENCAPSULATION TECHNOLOGY - Achieving Reliable siRNA Drug Delivery for Inflammatory Diseases & Tumor Targeting by Nanoencapsulation
Olivia Merkel, PhD, and Christoph Zimmermann, PhD student, discuss the benefits of microfluidic encapsulation technology for gene silencing applications in cancer immunology and inflammatory diseases, where siRNA can potentially be used to downregulate genes associated with these pathologies.
EXECUTIVE INTERVIEW - Pace Analytical® Life Sciences: Delivering Science Better; Advancing Novel Therapies Through the Clinic to Commercialization
Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at PLS, discusses his experiences with the company and its recent growth.
ORAL MUCOSAL IMMUNOTHERAPY - Oral Mucosal Delivery of Allergenic Proteins for Inducing Tolerance in Food Allergic Individuals
William R. Reisacher, MD, highlights some of the differences between food allergy immunotherapy via the oral mucosal route versus exposure through the stomach and intestines.
AMRI Joins Network of Approved Manufacturers of Lipid Excipients for Pfizer-BioNTech COVID-19 Vaccine
Albany Molecular Research, Inc. recently announced that the company has been chosen to support the development and manufacture of lipid excipients for the Pfizer-BioNTech COVID-19 vaccine.…
Vaccinex Announces Signing of Two Multi-Project Deals With Leading Pharmaceutical Companies
Vaccinex, Inc. recently announced the signing of multi-project deals with two undisclosed prominent pharmaceutical companies…..
SIRION Biotech & Sanofi Join Forces to Develop Gene Therapies for Multiple Life-Threatening Disorders
SIRION Biotech GmbH recently announced it signed a license and collaboration agreement with Sanofi to develop improved tissue-selective adeno-associated virus (AAV) vectors to realize….
