Formulation Development
Innovate Biopharmaceuticals Announces Start of First Phase 3 Clinical Trial
Innovate Biopharmaceuticals, Inc. recently announced the start of the first Phase 3 clinical trial in celiac disease. Innovate expects to provide further updates as screening…
Deciphera Pharmaceuticals and Zai Lab Limited Announce Exclusive License Agreement
Deciphera Pharmaceuticals, Inc. and Zai Lab Ltd. recently announced an exclusive license agreement to advance the development and commercialization of ripretinib in Greater China (mainland…
InflaRx Treats First Patient in Phase 2a Clinical Trial
InflaRx N.V. recently announced the treatment of the first patient in a Phase 2a clinical trial evaluating the company’s lead product candidate, IFX-1, in Pyoderma…
Oncologie Closes $80-Million Financing for Clinical-Stage Pipeline
Oncologie recently announced it has closed an $80M Series B financing. Existing investors, led by Nan Fung Life Sciences and Pivotal BioVentures China, are joined…
CytoDyn & FDA Will Meet to Potentially Finalize Protocol for Pivotal Monotherapy Trial
CytoDyn Inc. recently announced the US FDA has requested an in-person meeting to discuss and potentially finalize the company’s recently submitted protocol for a pivotal…
Ligand Subsidiary Vernalis & PhoreMost Limited Announce Collaboration for Novel Oncology Target
Ligand Pharmaceuticals Incorporated and PhoreMost Limited recently announced the signing of a research collaboration agreement between Ligand’s subsidiary Vernalis and PhoreMost on an undisclosed novel oncology target.
Designing a CMC Strategy for Accelerated Development of Biotherapeutics
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..
DRGT Completes a Pivotal Phase I Trial; Results Confirm 6X Faster Attainment of Maximum Plasma Levels
Druggability Technologies Holdings (DRGT) recently announced results from a pharmacokinetic study of their novel formulation of celecoxib (DRGT-46), which achieves faster time to maximum plasma concentration (Tmax) compared to traditional celecoxib capsules.
Insilico Launches Comprehensive Portfolio of Predictive Digital Twins for Cell Culture Process Development
In close alignment with customer needs Insilico Biotechnology AG has developed a modular suite of Digital Twins that cover key steps during bioprocess development.
Biogen Completes Acquisition of Nightstar Therapeutics for Approximately $800 Million
Biogen recently announced it has completed its acquisition of Nightstar Therapeutics, a clinical-stage gene therapy company, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders.
Aptar Acquires Nanopharm & Gateway Analytical
AptarGroup, Inc. recently announced it has acquired two leading pharmaceutical services companies, Nanopharm Ltd. and Gateway Analytical LLC, for a combined enterprise value of approximately $50 million.
ASLAN Pharmaceuticals Completes Phase 1 Study
ASLAN Pharmaceuticals recently announced the successful completion of its single ascending dose (SAD) study testing the first-in-class therapeutic antibody ASLAN004 in healthy volunteers, and the…
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.
