Formulation Development
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…
Ocugen Announces First Patient Dosed in Phase 1/2 Clinical Trial for Gene Therapy Candidate
Ocugen, Inc. recently announced the first patient has been dosed in the Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa….
Lonza Joins IPAC-RS, an International Consortium Advancing the Regulatory Science of Inhalation Products
Lonza recently announced its membership in the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Through this consortium, Lonza will collaborate with other industry…
Outlook Therapeutics Submits BLA to FDA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics, Inc. recently announced it has submitted its Biologics License Application (BLA) to the US FDA for ONS-5010, an investigational therapy which, if approved,…
Allergy Therapeutics Selects AGC Biologics to Manufacture Novel Peanut Allergy Vaccine Candidate
AGC Biologics recently announced a new partnership with Allergy Therapeutics, the fully integrated specialty pharmaceutical company specializing in allergy vaccines. The CDMO has manufactured Phase 1…
Cidara Therapeutics Announces Completion of Dosing the First Cohort of Healthy Volunteers in Phase 1 Trial
Cidara Therapeutics, Inc. recently announced the first cohort of healthy volunteers has been dosed in its Phase 1 trial of CD388, a highly potent long-acting…
Silo Pharma Enters Agreement With CRO for Pharmacokinetic Study
Silo Pharma, Inc. recently announced it has entered into an agreement with Frontage Laboratories, a CRO providing integrated, science-driven, product development services throughout the….
Vyant Bio & OrganoTherapeutics Announce Strategic Collaboration
Vyant Bio, Inc. and OrganoTherapeutics recently announced they have entered into a collaboration agreement to work toward accelerating the discovery of drugs for the treatment of….
Qualigen Therapeutics Engages TD2 as Contract Research Organization for Preclinical Development
Qualigen Therapeutics, Inc. recently announced it has appointed the renowned contract research organization (CRO) Translational Drug Development (TD2) to lead the preclinical development of lead…
Mapi Pharma Receives US Patent Covering Methods of Suppressing or Alleviating Primary or Secondary Progressive MS With a Sustained-Release Glatiramer Acetate Depot
Mapi Pharma Ltd. recently announced it has been granted US Patent No. 11,167,003 titled Methods for suppressing or alleviating primary or secondary progressive multiple sclerosis….
