Formulation Development
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.
TARGET DISCOVERY PLATFORM - Multi-Omics, SITESEEKER® Technology & the Future of Targeted Protein Degradation
Alberto Moreno, PhD, and Laura Butler, PhD, discuss the challenges associated with gene editing technologies, such as gene-trap, RNAi, and CRISPR technologies, as they do not directly provide functional characterization or inform on the presence of well-defined drug pockets or enzymatic activity of the target genes.
Thermo Fisher Scientific Introduces Next-Generation Unmixing Beads to Enhance Accuracy & Performance in Spectral & Conventional Flow Cytometry
Thermo Fisher Scientific has introduced Invitrogen™ UltraComp eBeads™ Spectral Unmixing Beads to improve accuracy in spectral and conventional flow cytometry. These beads help researchers more…
Orexo's AmorphOX Technology May Pave the Way for Intranasal GLP-1 Medication
Orexo AB recently announced positive pharmacokinetic in-vivo data for a powder-based intranasal semaglutide formulation developed with the AmorphOX technology. In the in-vivo study, three different…
Onco3R Therapeutics Announces Approval of First Clinical Trial Application for Novel SIK3 Inhibitor O3R-5671 in Autoimmune Diseases
Onco3R Therapeutics recently announced the approval of a Clinical Trial Application (CTA) by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. The trial will…
MBX Biosciences Doses First Participant in Phase 1 Trial of MBX 4291 for the Treatment of Obesity
MBX Biosciences, Inc. recently announced dosing of the first participant in its Phase 1 trial of MBX 4291, the company’s Precision Endocrine Peptide (PEP) glucagon-like…
Opus Genetics Doses First Patient in Pivotal LYNX-3 Phase 3 Trial Evaluating Phentolamine Ophthalmic Solution 0.75% in Keratorefractive Patients With Visual Disturbances Under Mesopic, Low-Contrast Conditions
Opus Genetics, Inc. recently announced the first patient has been dosed in LYNX-3, the company’s pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75%…
Regen BioPharma Explores Expanded Use of HemaXellerate for Chemotherapy-Induced Bone Marrow Suppression
Regen BioPharma, Inc. recently announced its ongoing efforts to expand the clinical development of HemaXellerate, its novel cellular therapy, to address chemotherapy-induced bone marrow suppression,…
2025 Analytical Testing e-Book - New ICH Guideline Outlines E&L Principles
In this exclusive Drug Development & Delivery e-book, Stevanato Group discusses E&L from the perspective of lyophilized products, common E&L testing challenges, how to mitigate testing risks.
Artelo Biosciences Announces Positive Interim Phase 2 CAReS Results for the Treatment of Cancer Anorexia-Cachexia Syndrome
Artelo Biosciences, Inc. recently announced highly encouraging interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial with ART27.13, the Company’s peripherally acting cannabinoid…
CG Oncology Completes Enrollment in PIVOT-006
CG Oncology, Inc. recently announced it has completed enrollment in its Phase 3, randomized, open-label PIVOT-006 study comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance following…
