Formulation Development
FREEZE-DRYING MICROSCOPY - Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
REGENERATIVE MEDICINE - Delivering on the Promise of Regenerative Medicine in Type 1 Diabetes
Thomas Donner, MD, explains how advances in stem-cell engineering, immune-evasion technologies, and vascularization of implanted cells have the potential to generate novel therapeutics that could lead to reduced treatment burden for patients with T1D and infuse new energy into efforts at finding a cure.
EXECUTIVE INTERVIEW - PCI Pharma Services: Broadening Our Biologics Footprint, Together
Shawn Cain, SVP Development & Manufacturing at PCI Pharma Services, discusses the recent acquisition, the opportunities this presents to Biopharma companies, and the current trends in the sterile fill-finish industry.
AUTOMATION SOLUTIONS - The Future of Lab Tech Will Combine Automation, Accuracy & Agility
Rich Ellson and John Fuller, PhD, say accelerating development comes down to designing and using flexible automation solutions along with smarter instruments and new consumable paradigms to help meet researchers’ needs.
Nevakar Injectables Sells Six Development-Stage, Ready-to-Use Injectable Product Candidates to Endo Ventures Limited
Nevakar Injectables Inc. recently announced it has entered into an asset sale agreement with Endo Ventures Limited, a subsidiary of Endo International plc (Endo) for the sale of six of its….
Rancho Biosciences Launches the Single Cell Data Science Consortium With Four Charter Members
Rancho Biosciences recently announced the launch of its Single Cell Data Science (SCDS) pre-competitive consortium. The 3-year effort is supported in collaboration with the following…
Vaxxinity Receives FDA Fast Track Designation for UB-311 for Treatment of Alzheimer’s Disease
Vaxxinity, Inc. recently announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted Fast Track designation by the US FDA for the treatment of Alzheimer’s disease…..
Rhythm Pharmaceuticals Presents New Data from Phase 3 Trial Evaluating Setmelanotide in Patients with Bardet-Biedl Syndrome
Rhythm Pharmaceuticals, Inc. recently announced the presentation of new data supporting the potential for setmelanotide to treat the early onset obesity, hyperphagia, and metabolic impairment…
FDA Has Granted Veru a Pre-Emergency Use Authorization Meeting Date for Positive Sabizabulin Phase 3 COVID-19 Study
Veru Inc. recently announced the FDA has granted the company a pre-Emergency Use Authorization (EUA) meeting on May 10, 2022, for the positive Phase 3…
Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in ALS by Sanofi
Denali Therapeutics Inc. recently announced its partner Sanofi has commenced dosing in a Phase 2 study, named HIMALAYA, of SAR443820 (DNL788) in individuals with amyotrophic…
Harpoon Therapeutics & Roche to Collaborate on Clinical Trials to Study Novel Immuno-Oncology Combination for Small Cell Lung Cancer
Harpoon Therapeutics, Inc. recently announced it has entered into a clinical supply agreement with F. Hoffmann-La Roche Ltd (Roche) to supply atezolizumab (Tecentriq) for use in the….
WHITE PAPER: Selecting In-Vitro Dissolution Methodologies for Amorphous Solid Dispersions
Read about how achieving good in vivo performance is a key attribute for ensuring safety and efficacy of oral solid dosage (OSD) forms intended for systemic delivery.
Catalent Expands Nasal Drug Development & Manufacturing Capabilities at North Carolina Facility
Catalent recently announced it has successfully completed a significant expansion of its nasal capabilities at its Morrisville, Research Triangle Park (RTP), North Carolina, facility, to…
Copley Launches New Semi-Automation Tool for Inhaled Product Testing
Copley Scientific, the global leader in inhaled product testing equipment, has launched the new Gentle Rocker 100i, a simple, cost-effective device that boosts the productivity and repeatability of….
QSAM Biosciences Doses First Patient in its Clinical Trial for Radiopharmaceutical Drug Candidate for the Treatment of Bone Cancer
QSAM Biosciences Inc. recently announced the first patient commenced treatment in its clinical trial evaluating CycloSam in patients with metastatic bone cancer. QSAM previously announced…
HiberCell Announces First Patients Dosed in Phase 2 Clinical Trial of Odetiglucan in Combination with KEYTRUDA in Adult Patients With Metastatic, Hormone-Refractory Breast Cancer
HiberCell recently announced the first patients have been dosed in a Phase 2 clinical trial of odetiglucan plus KEYTRUDA (pembrolizumab) for the treatment of metastatic,…
Vaxxinity Completes Enrollment in Part B of UB-312 Phase 1 Clinical Trial for Parkinson’s Disease
Vaxxinity, Inc. recently announced it has completed patient enrollment for Part B of its ongoing Phase 1 clinical trial of UB-312 in Parkinson’s disease (PD). Vaxxinity’s…
Caladrius Biosciences & Cend Therapeutics Announce Definitive Merger Agreement
Caladrius Biosciences, Inc. and Cend Therapeutics, Inc. recently announced the companies have entered into a definitive merger agreement under which Cend will merge with a wholly owned subsidiary of….
Symeres Acquires Organix, Adding Lipids Expertise & Strategic Foothold in the US
Symeres recently announced the acquisition of Organix Inc., a US-based specialized organic chemistry services provider with a focus on lipids…..
SOTIO Initiates CLAUDIO-01 Trial With Antibody-Drug Conjugate SOT102 in Patients With Gastric & Pancreatic Cancer
SOTIO Biotech recently announced it has dosed the first patient in its Phase 1/2 CLAUDIO-01 trial of SOT102 in patients with gastric and pancreatic cancer. SOT102 is the lead program of….
