Formulation Development
Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety & Pharmacodynamic Data for a Potential New Hormone-Free Treatment for Vulvovaginal Atrophy
Daré Bioscience, Inc. recently announced the publication of results of its Phase 1/2 clinical study of DARE-VVA1, a proprietary, investigational formulation of tamoxifen for intravaginal…
Ventyx Biosciences Announces Completion of Enrollment of Phase 2 Trial of VTX002 in Ulcerative Colitis & Phase 2 Trial of VTX958 in Plaque Psoriasis
Ventyx Biosciences, Inc. recently announced it has completed patient enrollment in the Phase 2 trial of VTX002 in ulcerative colitis and the Phase 2 SERENITY…
Axol Bioscience Collaborates With StrataStem to Deliver Stem Cell-Based ‘Clinical Trial in a Dish’ for Alzheimer’s Disease
Axol Bioscience Ltd. has signed an exclusive agreement with StrataStem to access and commercialize its extensive collection of Alzheimer’s Disease (AD) patient samples…..
Ocular Therapeuti Completes Enrollment of the HELIOS Clinical Trial of OTX-TKI for the Treatment of Diabetic Retinopathy
Ocular Therapeutix, Inc. recently announced completion of enrollment in the HELIOS clinical trial of OTX-TKI. Using Elutyx technology, OTX-TKI is the company’s axitinib intravitreal implant…
European Patent Office to Grant ZyVersa Therapeutics’ Patent Application for Cholesterol Transport Mediator for Use in Patients With Diabetic Nephropathy/Diabetic Kidney Disease
ZyVersa Therapeutics, Inc. recently announces the European Patent Office has issued a “Notice of Intention to Grant” ZyVersa’s patent application covering the company’s Phase 2a-ready…
Anavex Life Sciences Announces Completion of Phase 2/3 Rett Syndrome Clinical Trial
Anavex Life Sciences Corp. recently announced the completion of dosing of all participants of the placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX2-73-RS-003 in pediatric patients with…
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First
Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.
FORMULATION FORUM - PLGA – A Versatile Copolymer for Design & Development of Nanoparticles for Drug Delivery
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the chemistry, properties, applications, and regulatory aspects of PLGA, and the future trends in the industry, especially those requiring the development of long-acting injectables for the treatment of a variety of rare diseases and for life cycle management.
DRUG DEVELOPMENT - Overcoming Challenges on the Path From Candidate Selection to First-in-Human Clinical Testing
Eleanor Row, PhD, explores the current challenges drug developers face in transitioning their candidate molecules to first-in-human (FIH) clinical trials, including what the different drug development functions should be considering at this stage, and how an integrated approach can help to accelerate your molecule’s pathway to trial and beyond.
DEVICE DEVELOPMENT - How to Ensure pMDI Drug Products Are Fit for the Future Market Landscape
Ross Errington explores the latest developments in the pMDI segment and explains the steps pharmaceutical companies need to take to ensure their pMDI drug products are ready to thrive in a very different market environment.
Catalent Expands OneBio® Suite for Integrated Development, Manufacturing & Supply Across Biologic Modalities
Catalent recently announced it has expanded its integrated development, manufacturing and supply solution, OneBio® Suite, across a range of biologic modalities, including antibody and recombinant…
EXECUTIVE INTERVIEW - Lifecore Biomedical: Emerging From Under the Radar
Darren Hieber discusses his company’s progress after his first year as Sr. Vice President of Corporate Development and Partnerships at Lifecore Biomedical.
EXCIPIENT TECHNOLOGY - A Juggling Act: Factors at Play in Your Choice of Solubilizing Parenteral Excipients
Joey Glassco, MBA, says the power of novel excipients such as Apisolex polymer could revolutionize the parenteral drug development landscape, effectively solubilizing a wide range of APIs without compromising on safety or stability.
ANTI-VIRAL RESEARCH - Anti-Viral Activity of Pimpinella anisum Extract In Vitro Study
Fouad Al-Bayaty, Mazen M. Jamil Al-Obaidi, Maryam Haki Al-Doori, and Omar Imad present a study conducted to evaluate the antiviral effectiveness of Pimpinella anisum against dengue virus.
Ajinomoto Integrates R&D Sites in Japan & Korea With Genedata Bioprocess
Genedata and Ajinomoto recently announced Ajinomoto has successfully rolled out Genedata Bioprocess® to its Korean sites, Ajinomoto Genexine, in line with….
Imbria Pharmaceuticals Completes Enrollment in Phase 2 IMPROVE-HCM Trial of Ninerafaxstat in Patients With Non-Obstructive Hypertrophic Cardiomyopathy
Imbria Pharmaceuticals, Inc. recently announced it has completed enrollment in the IMPROVE-HCM Phase 2 placebo controlled clinical trial of ninerafaxstat with 67….
Enterin Announces the Start of a First-in-Human Study of ENT-03 in Obesity & Type 2 Diabetes
Enterin Inc. recently announced the start of a Phase 1a study in obesity and Type 2 diabetes (IND #155001). The study is a first-in-human, single…
NovelMed Phase 1 Clinical Trial Shows Inhibition of the Alternative Pathway & Preservation of the Classical Pathway – A Long-Acting Anti-Properdin Monoclonal Antibody for PNH Patients
NovelMed Therapeutics, Inc. recently announced topline results from First-in-Human Phase 1 clinical trial of its complement blocker monoclonal anti-Properdin antibody, known as NM3086…..
Synlogic Announces Initiation of Synpheny-3 Global, Pivotal Phase 3 Study Evaluating SYNB1934 for Treatment of Phenylketonuria
Synlogic, Inc. recently announced the initiation of Synpheny-3, a global, pivotal Phase 3 study evaluating the efficacy and safety of SYNB1934 as a potential treatment…
Portage Biotech Reports Updated Interim Data for Lead iNKT Engager in Phase 1/2 Trial for the Treatment of Advanced Melanoma & Metastatic Non-Small Cell Lung Cancer
Portage Biotech Inc. recently announced updated interim data from the Phase 1 portion of the trial evaluating its lead invariant natural killer T cell (iNKT)…
