Formulation Development
Aerami Therapeutics Announces Orphan Drug Designation for Imatinib for the Treatment of Pulmonary Arterial Hypertension
Aerami Therapeutics, Inc. recently announced the US FDA has granted the company orphan drug designation for imatinib for treatment of patients with pulmonary arterial hypertension…
Quantum Genomics Presents Results From Phase 2b QUORUM Study of Firibastat in Heart Failure
Quantum Genomics recently announced results of the Phase 2b QUORUM study were presented by Prof. Gilles Montalescot (Paris) on August 27, 2021 during the 2021…
AC Immune Announces First Positive Cognitive Results for a Tau-Targeting Monoclonal Antibody in Alzheimer’s Disease
AC Immune SA recently announced Genentech, a member of the Roche Group, has informed the company that Lauriet, a placebo-controlled Phase 2 study evaluating the…
Quotient Sciences Announces Multimillion-Pound Investment in Drug Substance Manufacturing Facility
Quotient Sciences, the drug development and manufacturing accelerator, recently announced a £6.3 million-pound investment in its recently acquired manufacturing facility in Alnwick, UK…..
SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
FORMULATION DEVELOPMENT - A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
Masumi Dave, PhD, and Rollie Fuller monitor in this study ASA hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, they assess the impact of the excipient choices on the stability of ASA.
GENE THERAPY - Solving the Puzzle: Aligning the Pieces of Gene Therapy & Creating Success for Patients
Sue Washer, MBA, reviews the various elements that must come together in developing safe, effective, and commercially viable viral-based gene therapies.
NASAL SPRAY BIOEQUIVALENCE - Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
DRUG DEVELOPMENT EXECUTIVE - Poseida Therapeutics: Creating the Next Wave of Cell & Gene Therapies With the Capacity to Cure
Eric M. Ostertag, MD, PhD, CEO of Poseida Therapeutics, discusses the company’s innovative approach to develop safer, more effective, accessible and affordable cell and gene therapies for patients.
DIGITAL CUSTOM PLATFORM - PCI Pharma’s Digital Transformation: Reaching New Levels of Customer Experience
Wayne Hull and Rebecca Coutts, PhD, explain how incorporating digital transformation as core to their company’s business strategy was a decision based on increasing evidence that investment in digital solutions provides real and measurable returns.
HOT MELT EXTRUSION - API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.
Aptamer Group & Bio-Works Technologies Partner to Enable Improved Solutions for Gene Therapy Manufacturing
Aptamer Group Ltd and Bio-Works Technologies AB recently announced they have entered into an agreement to co-develop a new affinity resin for improved purification and scale up of….
Noxopharm Phase 1 Clinical Trial Shows Anti-Inflammatory Response in COVID-19 Patients
Noxopharm has released preliminary top-line data from its NOXCOVID Phase I clinical trial testing the suitability of idronoxil (Veyonda®), a TBK1 (TANK-binding kinase 1) inhibitor,…
BioPlx Announces Focus on Developing Cure for Antibiotic-Resistant Bacteria
Antimicrobial Resistance (AMR) is one of the greatest threats to society, human and animal health, and economic prosperity. Those are the unequivocal words regarding the…
Recipharm Launches New Laboratory to Expand Analytical Services Offering
Global contract development and manufacturing organisation (CDMO), Recipharm, has announced the completion of a new analytical laboratory at its facility in Bengaluru, India. The new…
Shape Therapeutics Enters Strategic Research Collaboration With Roche to Advance Breakthrough AAV-Based RNA Editing Technology for Neuroscience & Rare Disease Indications
Through this partnership Shape will apply its proprietary RNA editing platform RNAfix and potentially leverage its AAVid technology platform for next-generation tissue-specific adeno-associated viruses (AAVs) for the development of gene therapy for….
Vifor Pharma & Cara Therapeutics Announce US FDA Approval of Injection for Treating Moderate-to-Severe Pruritus in Hemodialysis Patients
Cara Therapeutics and Vifor Pharma recently announced the US FDA has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with….
SomaLogic & Twist Bioscience Corporation Announce Partnership to Discover Novel Therapeutic Targets & Antibodies
CM Life Sciences II and SomaLogic, Inc., and Twist Bioscience Corporation recently announced a collaboration aimed at creating novel antibodies and enabling innovative drug discovery based on….
Vyant Bio & Cyclica Announce a Strategic Collaboration to Identify Compounds to Treat CDKL5 Deficiency Disorder
Vyant Bio, Inc. and Cyclica, Inc. recently announced a non-exclusive strategic collaboration combining Vyant Bio’s patient-derived complex organoid biology alongside Cyclica’s….
Junshi & Coherus Biosciences Announce Positive Interim Results of CHOICE-01 Phase 3 Clinical Trial
Shanghai Junshi Biosciences Co., Ltd. and Coherus BioSciences, Inc. recently announced positive interim results from the pivotal study CHOICE-01 (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating….
