Formulation Development
Tenaya Therapeutics Presents Encouraging New Clinical & Preclinical Data From HDAC6 Inhibitor Program for the Potential Treatment of Heart Failure With Preserved Ejection Fraction
Tenaya Therapeutics, Inc. recently released new data for TN-301 at the 2023 Heart Failure Society of America (HFSA) Annual Scientific Meeting. TN-301 is Tenaya’s highly…
Bio-Rad Extends Range of Anti-Idiotypic Antibodies for Use in Preclinical & Clinical Drug Development
Range of highly selective anti-idiotypic antibodies now includes six antibodies specific to dupilumab and its biosimilars for bioanalysis and drug monitoring….
WHITEPAPER - The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation
This white paper evaluates the viscosity-reducing capacities of excipients and excipient combinations…..
Ocular Therapeutix Announces Initiation of its First Pivotal Clinical Trial of OTX-TKI in Wet AMD
Ocular Therapeutix, Inc. recently announced the initiation of its first pivotal clinical trial to evaluate OTX-TKI, the company’s axitinib intravitreal implant, for the treatment of…
Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone
Eton Pharmaceuticals recently announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter…
BioXcel Therapeutics Provides Update on Recent Developments for Late-Stage Clinical Programs & Expansion of IP Portfolio for Sublingual Film
BioXcel Therapeutics, Inc. recently provided an update on recent developments with its late-stage clinical programs as well as its patent portfolio for IGALMI (dexmedetomidine) sublingual…
Advent International & Warburg Pincus Complete Acquisition of Baxter’s BioPharma Solutions Business
Advent International, one of the largest and most experienced global private equity investors, and Warburg Pincus, a leading global growth investor, recently announced the completion of their previously announced acquisition of Baxter International Inc.’s BioPharma Solutions (BPS) business….
Oxford BioTherapeutics Announces Partner Boehringer Ingelheim Received US FDA Fast Track Designation for the Treatment of Extensive Stage Small Cell Lung Cancer & Extrapulmonary Neuroendocrine Cancers
Oxford BioTherapeutics (OBT) recently announced the US FDA has granted Fast Track designation to BI 764532 for the treatment of extensive stage small cell lung…
Ocean Biomedical Announces Newly Published Findings Demonstrating Ability to Restore Treatment Sensitivity to AstraZeneca’s Leading Lung Cancer Drug After Resistance Has Formed
Ocean Biomedical, Inc. recently announced its cancer-targeting immunotherapy antibody candidate has demonstrated effective tumor reduction against an aggressive subset of Non-Small Cell Lung Cancer (NSCLC)…
DELIVERY TECHNOLOGY - Topical NeuroDirect™ Ketamine in the Treatment of Neuropathic Pain Syndromes: Fibromyalgia, Neuropathy, Radiculopathy & Causalgia/Complex Regional Pain Syndrome
Ronald Aung-Din, MD, and Chantelle Martin, MBChB, explain how targeting such chronic pain with a fast-acting, non-systemic, convenient, and easy-to-use at-home NeuroDirect ketamine cream could be of significant benefit in patients with CRPS as well as other neuropathic pain states, including chronic neck and back pain.
FORMULATION FORUM - CUBOSOMES – The Next Generation of Lipid Nanoparticles for Drug Delivery
Jim Huang, PhD, and Shaukat Ali, PhD, shed light on the design and formation of cubosomes with special focus on their applications for delivery of hydrophobic and hydrophilic small and large molecules, including oncology drugs and polynucleotides (DNA, mRNA, and siRNA).
PLATFORM TECHNOLOGY - The PTXΔLNP® Platform: On the Promise of Developing New LNPs for Tomorrow’s mRNA Therapies
Charlotte Dunne, PhD, Katrin Radloff, PhD, and Leonidas Gkionis, PhD, review the PTXΔLNP platform and how it offers a synergistic sister technology to the mRNA platform to obtain potent mRNA-LNPs for therapeutic applications.
SOLUBILIZING & STABILIZING TECHNOLOGY - CAPTISOL® - Part Perseverance & Part Serendipity
Vince Antle, PhD, James Pipkin, PhD, and Lian Rajewski, PhD, say with decades of experience, proven safety, and recent and forthcoming authorizations in several new routes of delivery, the Captisol Team is looking forward to the next 2 decades and more of new drug products, new applications, and continued improvement in the technology.
BIOLOGICS DEVELOPMENT - Five Steps to a Robust Cell Line Development Process
Robert Gustines reviews the critical steps for designing and implementing a robust cell line development process to help overcome the obstacles that often hinder biologic production.
FUNCTIONAL EXCIPIENTS - Much More Than Filler: Solving the Challenge of Patient Non-Compliance
Carin Siow, PhD, explains how the progress to tackle the root causes of medication mis-use has been frustratingly slow and believes the pharma industry’s secret weapon in the fight against non-compliance are functional excipients.
Zevra Therapeutics Announces Interim Data From Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia
Zevra Therapeutics, Inc. recently announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic…
Assembly Biosciences Nominates Development Candidate ABI-6250, an Orally Bioavailable HDV Entry Inhibitor
Assembly Biosciences, Inc. recently announced the selection of development candidate ABI-6250 to progress to IND-enabling studies. ABI-6250, an orally bioavailable small molecule entry inhibitor, is…
EXECUTIVE INTERVIEW - HERMES PHARMA: Reducing Risk, Speeding Development - A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
PRIMARY CONTAINER CLOSURE SYSTEMS - In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
PLACENTA-ON-A-CHIP - The Future of Drug Discovery In Women’s Health
Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.
