Formulation Development
Foamix Announces Publication of Phase 3 FMX101 Study
Foamix Pharmaceuticals Ltd. recently announced the peer review publication of the Phase 3 study FX2017-22 (Study 22) in the Journal of the American Academy of…
BioXcel Therapeutics Announces FDA Clearance of IND Application
BioXcel Therapeutics recently announced an update of its immuno-oncology program for BXCL701, an orally available systemic innate-immune activator with dual mechanisms of action. BTI is…
Allena Pharmaceuticals Announces Interim Study Results
Allena Pharmaceuticals, Inc. recently announced interim data from Study 206, its Phase 2 basket clinical trial of reloxaliase, an orally administered, recombinant oxalate-degrading enzyme. Study…
VBI Vaccines Reports Data From Part A of the Ongoing Phase 1/2a Study
VBI Vaccines Inc. recently presented a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting that exhibited expanded clinical data from Part A…
Verseon Showcases Oral Candidates for Next-Generation Diabetic Eye Disease Drugs
Verseon recently presented a new class of oral candidate drugs, which could not only revolutionize the treatment of diabetic macular edema (DME), but could also be effective in preventing this increasingly common condition.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
PARENTERAL DEVELOPMENT - Considerations in Developing Complex Parenteral Formulations
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
BIOSIMILAR DEVELOPMENT - Approval of Biosimilar Medicines Through Totality of the Evidence
Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.
MARKET BRIEF - Nothing Degrading About Saving Lives: E3 Ligands Recruiting New Drugs Into the Clinic
Marianna Tcherpakov, PhD, discusses underexploited strategies, traditional approaches that can be optimized, novel techniques beginning to emerge and pay dividends, and results propelling this field toward better clinical outcomes.
FORMULATION FORUM - Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development
Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.
2018 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline
In conclusion of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, reviews and compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.
ABITEC Improves Solubility of Topical & Transdermal Applications With Functional Lipid Excipients
ABITEC Corporation, a global manufacturer of functional lipid excipients continues to pursue new technologies that solve various formulation challenges in the pharmaceutical market.
Treos Bio Announces Positive Interim Results from a Phase 1/2 Clinical Trial
Treos Bio Limited reported positive interim results from its first-in-man Phase 1/2 study of its precision cancer vaccine with maintenance therapy in patients with metastatic…
Nanobiotix Announces Launch of Nanotechnology Platform
NANOBIOTIX recently announced the launch of new subsidiary Curadigm, dedicated to redefining the therapeutic balance between bioavailability, toxicity, and efficacy across the pharmaceutical industry. The…
Pfenex & Alvogen Announce EMA Accepts Marketing Authorization Application
Pfenex Inc. and Alvogen recently announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) submitted by our partner Alvogen for…
Mereo BioPharma Announces Positive Early 6-Month Data
Mereo BioPharma Group plc recently announced encouraging 6-month data from the open label arm of its Phase 2b dose-ranging clinical study in adults with Type…
Fluidigm Introduces Advanta RNA Fusions NGS Library Prep Assay
Fluidigm Corporation recently introduced the Advanta™ RNA Fusions NGS Library Prep Assay for detection of over 380 gene fusion pairs from solid tumors and hematological…
Sol-Gel Technologies Announces Seventh Agreement
Sol-Gel Technologies, Ltd. recently announced it has entered into a seventh collaborative agreement with Perrigo Israel, an affiliate of Perrigo Company plc for the development, manufacturing, and commercialization of two new generic formulations of antibiotic foams.
Biomunex Pharmaceuticals Establishes US Subsidiary
Biomunex Pharmaceuticals recently announced that it has established its US subsidiary, Biomunex Pharmaceuticals Inc., in Cambridge, MA.
Catalent Completes Acquisition of Gene Therapy Leader for $1.2 Billion
Catalent, Inc. recently announced it has completed the $1.2-billion acquisition of Paragon Bioservices, Inc., a leading viral vector development and manufacturing partner for gene therapies.…
