Formulation Development
Sterling Pharma Solutions Expands Capabilities & Laboratory Capacity
Sterling Pharma Solution recently announced a £1 million expansion project at its Deeside, UK site, which is the company’s dedicated bioconjugation and antibody-drug conjugates (ADCs)…
Verrica Pharmaceuticals Announces First Patient Dosed in Phase 2 Study for Potential First-in-Class Oncolytic Peptide-Based Immunotherapy
Verrica Pharmaceuticals Inc. recently announced the first patient has been dosed in the company’s Phase 2 trial of LTX-315, a potential first-in-class oncolytic peptide, for the….
Processa Pharmaceuticals Announces First Patient Enrolled in Phase 2A Trial for the Treatment of Gastroparesis
Processa Pharmaceuticals, Inc. recently announced it has enrolled its first patient in the Phase 2A clinical trial of PCS12852 in patients with moderate-to-severe gastroparesis. Gastroparesis…
Agenus’ CD137 Agonist Advances in the Clinic, Triggering Milestone Payment From Gilead
Agenus Inc. recently announced receipt of a $5-million clinical milestone payment for AGEN2373 (conditionally active CD137 agonist). AGEN2373 is being evaluated in a Phase 1b…
SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
GLOBAL REPORT - 2021 Global Drug Delivery & Formulation Report: Part 1, A Review of 2021 Product Approvals
In part 1 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2021 product approvals.
FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
EXECUTIVE INTERVIEW - Syner-G BioPharma: A Track Record of CMC Excellence
Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.
PLATFORM TECHNOLOGY - Predictive Medicine, Biomarkers & the Multiple Unmet Needs in Acute Respiratory Distress Syndrome
Joe G.N. Garcia, MD, and Stan Miele believe the unmet need in ARDS is to identify reliable, validated ARDS biomarkers that minimize ARDS heterogeneity and allow for stratification of subject selection for enrollment in clinical trials of tailored therapies. Combined with a more streamlined drug-approval process, biomarker- and genotype-based treatment of specific ARDS endotypes has never been as within reach as it is today.
BATCH RELEASE - The Business Case for Reinventing Batch Release
Aparna Seksaria reviews how for pharmaceutical companies — and pharma supply chains — to bring safe, commercial-ready products to market quickly and profitably, and for them to meet growing demand for highly personalized, batch-size-one types of products, it’s critical that they take steps to de-risk and speed up processes like batch release, and do so without compromising quality, safety or the bottom line.
UK Government to Support Expansion of Croda’s Lipid Systems Manufacturing Facility
Croda International Plc that uses smart science to create high performance ingredients and solutions that improve lives, recently announced that it has been awarded a £15.9 million grant by the UK Government to expand….
New BD Assay Advances Immunology Research Capabilities in the Developing Field of Multiomics
BD (Becton, Dickinson and Company) recently released the BD Rhapsody TCR/BCR Multiomic Assay, an innovative set of reagents that enables researchers to more easily and…
PERMEABILITY STUDIES - Onion Epithelial Membrane as a Model for Predicting Intestinal Absorption of Drugs
Antoine Al-Achi, PhD, Mounika Nangineedi, MS, Chaitali Koli, MS, et al, study 19 drugs with varying partition coefficient, water solubility, and molecular weight values to compare their diffusion through the middle epithelial membrane of onion with that of their Caco-2 cell line.
Athira Pharma Doses First Subject in Phase 1 Clinical Trial of HGF/MET Positive Modulator
Athira Pharma, Inc. recently announced that the first subject has been dosed in a Phase 1 clinical trial investigating ATH-1020, an orally available,….
Starton Therapeutics Announces FDA Clearance of IND Application
Starton Therapeutics Inc. recently announced the US FDA has cleared an investigational new drug (IND) application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV). STAR-OLZ is a multi-day transdermal….
Inozyme Pharma Announces Positive Preliminary Data from Phase 1/2 Clinical Trial
Inozyme Pharma, Inc. recently announced positive preliminary biomarker, safety, and pharmacokinetic (PK) data from the first three patients treated in the Phase 1 portion of its…
CymaBay Therapeutics Announces Results From 52-Week, Open-Label, Phase 2 Study
CymaBay Therapeutics, Inc. recently announced that results from the Phase 2, 52-week study of seladelpar in patients with primary biliary cholangitis (PBC) have been published…
Halberd Continues In Vitro Successes With Elimination of Protein Linked to Depression
Halberd Corporation demonstrated the extracorporeal elimination of C-Reactive Protein from cerebral spinal fluid (CSF) by exposure to tuned laser light, in vitro. Halberd, encouraged by…
On-Demand Webinar: How to Safely Handle Your Antibody Drug Conjugate
Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications…..
Novel Nuclear MicroRNA is Being Developed for the Treatment of Cardiovascular Disease
A novel angiogenic microRNA drug can be a new option for the treatment of ischemic cardiovascular disease, according to a new study published in PLOS…
