Formulation Development
Belite Bio Announces Completion a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt Disease
Belite Bio Inc. recently announced the completion of the last subject visit in the Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt…
Silexion Therapeutics Reports Positive Preclinical Data Demonstrating SIL204’s Reach & Activity in Major Pancreatic Cancer Metastatic Sites Following Systemic Administration
Silexion Therapeutics Corp. recently announced new preclinical data demonstrating that subcutaneously administered SIL204 successfully reaches all primary sites of pancreatic cancer metastasis and shows anti-tumor…
Trethera Successfully Completes Enrollment of Phase 1 Dose Escalation Trial for Patients With Solid Tumors
Trethera Corporation recently announced the final patient has enrolled in its Phase 1 dose escalation trial for the treatment of advanced solid tumors. Patients have…
Symeres Acquires DGr Pharma to Enhance Regulatory Expertise & Broaden Biopharma Capabilities
Symeres recently announced the acquisition of DGr Pharma, a drug development-focused consultancy, to expand its integrated early-stage drug development services and accelerate IND-enabling capabilities for…
Karyopharm Announces Completion of Enrollment in the Phase 3 SENTRY Trial in Myelofibrosis
Karyopharm Therapeutics Inc. recently announced it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve…
SPECIAL FEATURE - Injection Devices: Faster, Integrated, and Flexible for the IV to SC Transition
Contributor Cindy H. Dubin speaks with several companies who highlight how device developers are addressing various challenges while still ensuring precise dosage control and patient compliance.
Biosplice Therapeutics Announces First Patient Dosed in NCI-Sponsored Clinical Trial of Cirtuvivint in AML & Myelodysplastic Syndromes
Biosplice Therapeutics, Inc. recently announced the first patient has been dosed in a Phase 1 clinical trial of cirtuvivint in patients with acute myeloid leukemia…
HCW Biologics Reports Positive Results From Non-Human Primate Study for its Proprietary Second-Generation T-Cell Engager Program
HCW Biologics Inc. recently announced its scientists have successfully developed second-generation, tissue factor-targeting T-cell engagers against solid tumors, particularly for pancreatic cancer and glioblastoma, constructed…
Enlivex Announces Issuance of New Patent Application Covering the Use of Allocetra in Patients With Osteoarthritis
Enlivex Therapeutics Ltd. recently announced the issuance of an Israeli patent, numbered 290470, titled THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS. The patent will provide…
Lilly Launches TuneLab Platform to Give Biotechnology Companies Access to AI-Enabled Drug Discovery Models Built Through Over $1 Billion in Research Investment
Eli Lilly and Company recently announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug…
Tagworks Pharmaceuticals Announces Initiation of Third Dose Level in Ongoing Phase 1 Clinical Trial for Solid Tumor Treatment
Tagworks Pharmaceuticals BV recently announced the third dose level has been initiated in the ongoing Phase 1 clinical trial evaluating TGW101, a first-in-class antibody-drug conjugate…
FORMULATION FORUM - Hot Melt Extrusion – An Enabling Technology for Poorly Soluble Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say in spite of many challenges, drug manufactures continue to look for non-conventional, and often novel, polymers to expedite the development of innovative molecules coming out of discovery when none of the conventional technologies do not meet the desired objectives.
PULMONARY DELIVERY - Development of Pulmonary Dosage Forms for the Successful Delivery of Complex Molecules
Richard Johnson, PhD, believes there is growing interest in next-generation pulmonary delivery devices that can overcome delivering drugs more efficiently into the deep lung and also delivering thermally sensitive drugs that are unstable in solution.
EXECUTIVE INTERVIEW - Lonza & Ethris: Advancing mRNA Vaccines: Room-Temperature Stable, Spray-Dried Formulations for Enhanced Mucosal Delivery
Kim Shepard, Director of Advanced Drug Delivery at Lonza, and Carsten Rudolph, PhD, Co-founder and Chief Executive Officer at Ethris, discuss the main objectives of the collaboration and the benefits of spray-dried mRNA vaccines.
WHITEPAPER - Drug Delivery – Recent Trends, Enabling Technologies, In-Vitro-In-Vivo Predictions & Personalized Medicine
Enabling technologies such as Nanotechnology, Amorphous Solid Dispersions, Self-emulsifying/nanoemulsifying drug delivery systems (SEDDS/SNEDDS) or Lipid Nano Particles (LNPs) for oral delivery are key elements for the development of complex and difficult to develop small molecules.
EXECUTIVE INTERVIEW - ALZpath: A Diagnostic Assay Changing the Future of Alzheimer’s Disease
Jacob Hunter, Chief Business Officer, ALZpath, Inc., discusses the development and deployment of the company’s proprietary pTau217 antibody, bridging the gap between detection and treatment to improve patient outcomes globally.
FORMULATION DEVELOPMENT - Innovative Drug Delivery Approaches for GLP-1 Agonists: Enhancing Medication Adherence & Treatment Outcomes
Nasrin Mahmoudi, PharmD, PhD, and Michael Baumann, highlight recent developments in GLP-1 agonist formulations and delivery methods, including advanced injectable formulations, novel oral delivery systems, and topical formulations.
Lexicon Pharmaceuticals Announces Submission of Additional Data to FDA Supporting the Benefit-Risk Profile of Zynquista in Type 1 Diabetes
Lexicon Pharmaceuticals, Inc. recently announced it has submitted additional clinical data to the US FDA from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission…
Novonesis & Novo Nordisk to Explore New Solutions for Metabolic Health
Novonesis and Novo Nordisk have entered a research partnership to explore the role of the gut microbiome in the maintenance of metabolic health. The gut…
LIPID SOURCING & SELECTION - Navigating the Lipid Landscape: Overcoming the Challenges of Lipid Sourcing & Selection for LNPs
Donald Kelemen, PhD, says one of the most significant challenges lies in selecting and sourcing the molecules at the heart of LNPs: lipids. The right choices can optimize stability, efficacy, and scalability, while the wrong ones can introduce roadblocks that are difficult (and costly) to overcome.
