Formulation Development
CELL & GENE THERAPY - It’s Time to Build Infrastructure to Handle the Coming Surge
Fran Gregory says the complexities and innovations associated with the production of cell and gene therapies also necessitates a shift in infrastructure, which will affect manufacturers, distributors, and providers. From development, manufacturing, storage, and delivery to patients; each step in the process requires forging a new path.
FORMULATION FORUM - Prefilled Syringes: Overcoming the Challenges for Safe & Accurate Delivery of Drugs
Shaukat Ali, PhD, and Jim Huang, PhD, provide a better understanding about some of the advantages of prefilled syringes, methods for manufacturing, and the syringe types commercially available.
MannKind to Proceed With Phase 1 Nintedanib DPI Study for Pulmonary Fibrotic Diseases
MannKind Corporation recently announced it will proceed with a first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis…
Biora Therapeutics Announces Completion of Multiple-Ascending Dose Cohorts for Clinical Trial of BT-600
Biora Therapeutics, Inc. recently announced completion of dosing for the multiple-ascending dose cohorts for its clinical study of BT-600, a drug-device combination consisting of the…
Wave Life Sciences Announces Approval of First Clinical Trial Application for RestorAATion-2 Trial of WVE-006 in Individuals With Alpha-1 Antitrypsin Deficiency
Wave Life Sciences Ltd. recently announced the approval of its first clinical trial application (CTA) for its RestorAATion-2 clinical trial of WVE-006, the company’s first-in-class…
Biotts Becomes First Company to Successfully Deliver Insulin Through Skin
Patients with Type 1 diabetes could replace up to 20 insulin injections over a period of five days….
FORMULATION DEVELOPMENT - The Rising Need for an Integrated Approach to Small Molecules Drug Development
Julian Northen, PhD, believes as the demands of a changing society evolve and continue to act as a driver for the identification of novel small molecules, the roles and diversity of the available medicines will also change.
EXECUTIVE INTERVIEW - Cocrystal Pharma: Utilizing Structure-Based Technologies to Provide First- & Best-In-Class Antiviral Drugs to Address Critically Unmet Medical Needs
Dr. Sam Lee, Cocrystal Pharma’s President and co-CEO, discusses the company’s latest achievements in antiviral drug development.
DRY POWDER FORMULATION - Preparing to Deliver the Next Generation of Inhaled Therapeutics
Richard Johnson, PhD, outlines the trends and challenges within the inhaled drug delivery market. Specifically, DPI delivery will be explored, including how the challenges with dry powder formulation can be overcome and what the future holds for DPIs.
Lonza Launches AI-Enabled Route Scouting Service to Accelerate Small Molecule Development
New advanced technology-enabled offering aims to streamline synthetic route identification for novel active pharmaceutical ingredients (APIs)….
TFF Pharmaceuticals Makes Available Phase 2 Data From Tacrolimus Inhalation Powder for the Prevention of Lung Transplant Rejection
TFF Pharmaceuticals, Inc. recently announced data from the company’s ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant…
ENA Respiratory Announces FDA IND Clearance for First-in-Class Antiviral Innate Immunomodulator
ENA Respiratory recently announced the US FDA has issued a "safe to proceed" notice for its investigational new drug (IND) application for a Phase 1b…
Coave Therapeutics Showcases its ALIGATER Platform for Generating Conjugated AAV Vectors Exhibiting Superior Performance in Delivering Ocular Gene Therapy Through the Suprachoroidal Route
Coave Therapeutics recently announced preclinical studies on its novel Conjugated AAV (coAAV) gene therapy vectors demonstrate promising results for ocular gene therapy. Engineered coAAV vectors,…
Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical for $2.4 Billion
Deciphera’s kinase inhibitor expertise and established commercialization platform in key markets will reinforce ONO Pharmaceutical’s pipeline and accelerate global reach….
Corcept Completes Enrollment in Phase 4 Trial
Corcept Therapeutics Incorporated recently announced completion of enrollment in CATALYST, a Phase 4 trial examining the prevalence of hypercortisolism (Cushing’s syndrome) in patients with difficult-to-control…
CanSinoBIO CSO Shares Latest Results of Innovative Pneumococcal Vaccine
On April 20, the 2024 National Vaccines and Health Conference organized by the Chinese Preventive Medicine Association (CPMA) and the Chinese Center for Disease Control…
Abzena Launches Next-Generation Immunogenicity Tool for De-Risking the Development of Complex Biologics & Bioconjugates
Abzena recently announced the launch of its enhanced bioassay platform EpiScreen® 2.0, a comprehensive suite of assays that predict and evaluate potential risks of preclinical immunogenicity in protein….
Biolojic Design Announces Nektar Therapeutics Has Exercised its License Option to Develop an AI-Designed Agonistic Antibody Targeting TNFR2 for the Treatment of Autoimmune Diseases
Program is the Product of a Research Collaboration between Biolojic Design and Nektar entered in 2021….
Immutep Announces Positive Preliminary Topline Results From TACTI-003 Cohort B
Immutep Limited recently announced preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase 2b trial evaluating eftilagimod alpha (efti) in combination with MSD’s…
PEP-Therapy & Institut Curie Announce First Patients Dosed in Phase 1b Clinical Trial Evaluating PEP-010 in Ovarian & Pancreatic Cancers
PEP-Therapy and Institut Curie recently announced the dosing of the first patients in a Phase 1b clinical trial evaluating PEP-Therapy’s lead candidate, PEP-010, based on…
