Formulation Development
DepYmed Receives FDA Rare Pediatric Disease & Orphan Drug Designations for its Lead Clinical Candidate for the Treatment of Rett Syndrome
DepYmed Inc. recently announced that the US FDA has granted Rare Pediatric Disease and Orphan Drug designations for its lead clinical candidate, a small molecule…
Hepion Pharmaceuticals Announces Clinical Collaboration With HepQuant in Phase 2b NASH Trial
Hepion Pharmaceuticals, Inc. recently announced it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for…
Lubrizol Life Science Health Launches Innovative Apisolex(TM) Technology to Improve Solubility & Simplify Manufacturing of Parenteral Drug Products
Lubrizol Life Science (LLS) Health, a global leader in accelerating success and innovation in pharmaceutical development, has launched Apisolex, a novel solubility-enhancing excipient for use in….
GLOBAL REPORT – 2021 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery and Formulation Product Approvals and Technologies of 2021
In part 2 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
ARTIFICIAL INTELLIGENCE - Modernizing Your Clinical Development Safety Practices With Artificial Intelligence
Updesh Dosanjh, MS, says by continuing to explore the ability of these technologies to deliver better and safer treatments, pharmaceutical companies can benefit not only the advancement of the medical community, but the quality of life of patients around the world.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: The Journey to Become a Full-Service Provider
Tom Sellig, CEO at Adare Pharma Solutions, discusses his expectations for Adare and how he can leverage his 30-plus years of pharma experience to put Adare in a competitive position to address complex formulation and development challenges.
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….
