Formulation Development
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)…
Artax Biopharma Announces Positive Phase 1 Results for Company’s First-in-Class Oral Immunomodulator Developed to Treat T Cell-Mediated Diseases
Artax Biopharma, Inc. recently announced positive Phase 1 clinical trial results for AX-158, the company’s first-in-class oral small molecule immunomodulator to enter clinical development to…
Medigene Announces Pipeline Expansion Into Neoantigens With Programs Targeting Multiple KRAS Mutations & HLAs
Medigene AG recently announced its pipeline expansion into neoantigens (also known as oncogenic driver mutations) with KRAS (Kirsten rat sarcoma viral oncogene homologue) as the…
Wheeler Bio and Charles River Laboratories Announce Agreement to Build & Operate RightSource Laboratory
Wheeler Bio, Inc. and Charles River Laboratories International, Inc. recently announced an agreement to implement RightSource at Wheeler Bio’s current good manufacturing practice (cGMP) biologics manufacturing facility….
Upperton Pharma Solutions Increases Oral Dosage Form Capabilities at Its Nottingham HQ
Upperton Pharma Solutions has expanded its oral dosage form capabilities at its newly built headquarters in Nottingham, UK. Part of Upperton’s £15m investment program announced…
Coave Therapeutics Announces Positive 12-Month Data From Ongoing Phase 1/2 Clinical Trial of CTx-PDE6b in Patients With Retinitis Pigmentosa Caused by Bi-allelic Mutations in PDE6b
Coave Therapeutics recently announces the positive 12-month results from its Phase 1/2 trial evaluating the safety and efficacy of its innovative gene therapy, CTx-PDE6b, for…
