Formulation Development
Pfenex Announces US Commercial Launch of Teriparatide Injection
Pfenex Inc. recently announced that its commercialization partner, Alvogen, has launched Teriparatide Injection in the US. Teriparatide Injection (also referred to as PF708 and Bonsity)…
Glyscend Therapeutics Completes $20.5-Million Financing Round to Advance Novel Oral Polymer Therapy
Glyscend Therapeutics recently announced the closing of a $20.5-million Series A financing round. Healthcare investors Brandon Capital Partners, through its Medical Research Commercialisation Fund (MRCF),…
Daré Bioscience Announces Receipt of $1.5 Million Under the Current Grant Supplement Award for Continued Development of User-Controlled Long-Acting Reversible Contraceptive
Daré Bioscience, Inc. recently announced the receipt by its wholly owned subsidiary of $1.5 million in additional grant funding from the Bill & Melinda Gates…
Phathom Pharmaceuticals Provides Clinical Trial Status Update
Phathom Pharmaceuticals, Inc. recently announced it has randomized the first new patients in each of its two Phase 3 clinical trials since temporarily pausing new…
Agios Announces Clinical Proof-of-Concept Has Been Established in Phase 1 Study
Agios Pharmaceuticals, Inc. recently announced that clinical proof-of-concept has been established based on a preliminary analysis in the Phase 1 trial of mitapivat (AG-348) in…
Melinta Therapeutics Enters Agreement to Acquire Tetraphase Pharmaceuticals
Melinta Therapeutics, Inc. recently announced that on June 4, 2020, it entered into a definitive merger agreement with Tetraphase Pharmaceuticals, Inc. pursuant to which…
Relief Therapeutics & NeuroRx Expand Clinical Trial of COVID-19 Drug
Relief Therapeutics and its US partner, NeuroRx, Inc. recently announced that the Phase 2/3 clinical trial evaluating RLF-100 as a treatment for critical COVID-19 with…
Vectura Signs License & Development Agreement With Aerami Therapeutics
Vectura Group plc recently announced the signing of a global license and development agreement with Aerami Therapeutics Inc. for inhaled….
Ovid Therapeutics Announces Strategic Research Collaboration Focused on Accelerating the Development of New Treatments for Rare Neurological Diseases
Ovid Therapeutics Inc. recently announced a strategic research collaboration with Columbia University Irving Medical Center researchers to advance genetic based therapies for……
CURE Announces Exercise of Warrants; Obtains Valuable Proprietary Formulation & Dosage Technology
CURE Pharmaceutical Holding Corp recently announced it strengthened its balance sheet with the receipt of $1.4 million in cash from the exercise of warrants to…
Cresset & Inocardia to Develop In Silico Cardiac Safety Assay for Drug Candidate Screening
Cressey Discovery Services and Inocardia recently announced a 1-year collaboration to develop improved computational methods for cardiac safety assessment. This collaboration also includes the University…
Rezolute Receives Rare Pediatric Disease Designation for Phase 2b Candidate
Rezolute, Inc. recently announced the company has received rare pediatric disease designation (RPD) from the US FDA for RZ358, a potential treatment for congenital hyperinsulinism…
Precision BioSciences Announces Dosing of First Patient in Phase 1/2a Clinical Trial
Precision BioSciences, Inc. recently announced that the first patient has been dosed in a Phase 1/2a clinical trial of PBCAR269A, its third allogeneic chimeric antigen…
Arch Biopartners Submits IND Application to the FDA for Metablok (LSALT Peptide)
Arch Biopartners Inc. recently announced it has submitted an Investigational New Drug (IND) Application to the US FDA for its lead drug Metablok (LSALT peptide)…
THERAPEUTIC FOCUS - The Future of Treating Alzheimer’s Disease: Aducanumab & Beyond
Hermann Russ, MD, PhD, and Alexander Gebauer, MD, PhD, believe the times when amyloid beta as a drug target have been dubbed a dead horse in the race for treatment of Alzheimer’s disease are now over.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
PFS MANUFACTURING - Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery
Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.
GENE THERAPY - The Role Viral Vectors Play in Current Gene Therapy Development
Dieter Lingelbach, MBA, discusses the history and science of viral vectors, their current applications, and why they are a vital component in contemporary gene therapy development.
FORMULATION FORUM - Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
FORMULATION DEVELOPMENT - Formulating Immediate-Release Tablets for Poorly Soluble Drugs
Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.
