Formulation Development
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.…
CureVac Enters Into Exclusive Sponsored Research Agreement
CureVac AG, a fully integrated biopharmaceutical company pioneering the field of mRNA-based drugs, recently announced it has entered into a sponsored research agreement (SRA) with…
Crinetics Pharmaceuticals Initiates Phase 1 Study for Treatment of Neuroendocrine Tumors
Crinetics Pharmaceuticals, Inc. recently announced the initiation of a Phase 1, double-blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics…
BioCryst’s Oral Drug Meets Primary Endpoint in Phase 3
BioCryst Pharmaceuticals, Inc. recently announced that the randomized (n=121), double-blind, placebo-controlled, Phase 3 APeX-2 trial of once-daily, oral BCX7353 for the prevention of hereditary angioedema…
WuXi STA & Dizal Pharmaceutical Sign Agreement
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, recently announced a strategic partnership.
Mercia Invests in Transdermal Drug Delivery Specialist
Medherant Limited, the clinical-stage developer of innovative transdermal delivery products for pain and CNS diseases using its unique TEPI Patch technology, recently announced a new $2.5-million investment.
