Drug Delivery
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
DBV Technologies recently announced that the US FDA has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety,…
BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial for Acute Treatment of Agitation in Patients With Alzheimer’s Disease
BioXcel Therapeutics, Inc. recently announced the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 (dexmedetomidine) sublingual film, the…
Avidity Announces Positive AOC 1001 Phase 1/2 MARINA Data Demonstrating First-Ever Successful Targeted Delivery of RNA to Muscle - Revolutionary Advancement for the Field of RNA Therapeutics
Avidity Biosciences, Inc. recently announced positive AOC 1001 data from the preliminary assessment of the Phase 1/2 MARINA trial demonstrating the first-ever….
Starton Therapeutics’ STAR-LLD Continuous Delivery Shows Superior Tumor Reduction & Progression Free Survival Compared to Pulsatile Lenalidomide Treatment in Lenalidomide-Resistant Model
Starton Therapeutics Inc. recently announced results from a 28-day efficacy study of STAR-LLD continuous subcutaneous (SC) infusion versus intraperitoneal (IP) lenalidomide in immunomodulatory drug (IMiD)-resistant…
Lantheus Grants Rights for the Use of its Microbubbles to SonoThera for its Ultrasound-Guided Nonviral Gene Therapy Platform
Lantheus Holdings, Inc. recently announced a strategic collaboration with SonoThera, Inc. in which Lantheus’ microbubbles will be used in combination with SonoThera’s ultrasound-guided, nonviral, gene…
Gerresheimer to Expand Significantly in High Value Solutions & Further Accelerates its Sustainable Profitable Growth
Gerresheimer AG recently reaffirmed its growth agenda and increased its revenue and adjusted EBITDA guidance. The company continues to execute consistently its formula g strategy…
Evonik Launches Plant-Based Squalene to Boost Vaccine Efficacy
Evonik has recently launched a non-animal-derived squalene suitable for vaccines and other pharmaceutical applications. PhytoSquene is the first known amaranth oil-derived squalene on the market…
Ocuphire Pharma Announces Submission of NDA for Eye Drops for Reversal of Mydriasis
Ocuphire Pharma, Inc. recently announced the submission of a New Drug Application (NDA) to the US FDA for Phentolamine Ophthalmic Solution 0.75% (Nyxol) for the…
Ventyx Biosciences Announces Dosing of the First Patient in Phase 2 SERENITY Trial for the Treatment of Moderate-to-Severe Plaque Psoriasis
Ventyx Biosciences, Inc. recently announced the first patient has been dosed in a Phase 2 trial of its selective, allosteric TYK2 inhibitor VTX958 for the…
Synlogic Announces SYNB1353 Achieves Proof of Mechanism for Treatment of Homocystinuria & Provides Business Update
Synlogic, Inc. recently announced SYNB1353 has achieved proof of mechanism and positive results in a Phase 1 study in healthy volunteers treated with multiple ascending…
2023 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
DRUG DELIVERY - Using the IPEG™ Delivery System to Topically Treat Rare Diseases in Dermatology While Limiting Systemic Absorption
Zachary Rome, Jessica Raiz, MPH, and Alan M. Mendelsohn, MD, are advancing innovative clinical research that is evaluating high-potential, low-risk treatments for rare dermatologic diseases using unique topical vehicles combined with established medications that enable the targeted delivery of therapies to the epidermis and dermis while minimizing systemic absorption.
First Wave BioPharma Files INDA for Enhanced Microgranule Delivery Formulation of Adrulipase
Upon IND clearance, Phase 2 clinical trial investigating adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis is expected to initiate in early 2023 with topline clinical data anticipated in the first half of 2023….
Aridis Announces a Key Milestone of Closing of Patient Enrollment in the Phase 2a Study of AR-501 in Cystic Fibrosis Patients
Aridis Pharmaceuticals, Inc. recently announced the closing of patient enrollment in the multiple ascending dose (MAD) and dose-ranging cohorts in the Phase 2a clinical trial of…
BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults With Bipolar I or II Disorder or Schizophrenia
BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, recently announced the first 13 patients have…
Avectas, CCRM & OmniaBio Expand Their Collaboration to Accelerate the Manufacture of Edited iPSCs Using SOLUPORE Technology
Avectas and CCRM, with its subsidiary OmniaBio Inc., have recently announced an expansion of their collaboration, to enable the development of gene-edited induced pluripotent stem….
Incannex Engages Eurofins to Manufacture Novel Addiction Treatments CannQuit-N and CannQuit-O
Incannex Healthcare Limited recently announced it has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific to manufacture Incannex’s two distinct medicated….
IntelGenx Receives FDA PDUFA Date for RIZAFILM
IntelGenx Corp., a leader in pharmaceutical films, recently announced the US FDA has accepted for review its Class 2 response to the 2020 Complete Response…
Attralus & Ossianix Announce Option & License Agreement Using the TXP1 Brain Shuttle for Targeted Delivery of a Pan-Amyloid Removal Therapeutic for Neurodegenerative Disorders
Attralus, Inc. and Ossianix recently announced they have entered into a definitive agreement using Ossianix’ brain shuttle technology to enhance the targeted delivery of novel….
Editas Medicine Announces Clinical Data Demonstrating Proof of Concept of EDIT-101 From Phase 1/2 BRILLIANCE Trial
Editas Medicine, Inc. recently announced clinical data from the Phase 1/2 BRILLIANCE trial of EDIT-101, an in vivo CRISPR/Cas9 genome editing medicine in a company-sponsored…
What are Drug Delivery Systems?
Drug delivery systems are engineered technologies for the targeted delivery and/or controlled release of therapeutic agents. The practice of drug delivery has changed significantly in the past few decades and even greater changes are anticipated in the near future. Drug delivery includes but is not limited to oral delivery, gene/cell delivery, topical/transdermal delivery, inhalation deliver, parenteral delivery, respiratory delivery, capsules, particle design technology, buccal delivery, etc.
The Evolution of Drug Delivery Systems
Drug delivery systems have greatly evolved over the past 6 decades. In the past 12 years specifically, there have been huge advancements in drug delivery technology. For instance, advanced medication delivery systems, such as transdermal patches, are able to deliver a drug more selectively to a specific site, which frequently leads to easier, more accurate, and less dosing overall. Devices such as these can also lead to a drug absorption that is more consistent with the site and mechanism of action. There are other drug delivery systems used in both medical and homecare settings that were developed because of various patient needs and researchers continue to develop new methods.
Drug Delivery System Market Size
The pharmaceutical drug delivery market size is studied on the basis of route of administration, application, and region to provide a detailed assessment of the market. On the basis of route of administration, it is segmented into oral delivery, pulmonary delivery, injectable delivery, nasal delivery, ocular delivery, topical delivery, and others.
The estimated global market size of drug delivery products was $1.4 trillion in 2020. Unfortunately, 40% of marketed drugs and 90% of pipeline drugs (mostly small molecules) are poorly soluble in water, which makes parenteral, topical, and oral delivery difficult or impossible. In relation, poor solubility often leads to low drug efficacy. Add in the fact that many other hurdles exist in the form of drug loading, stability, controlled release, toxicity, and absorption – it’s not hard to understand the difficulties in bringing new drug products to market. Additionally, biopharmaceuticals (proteins, peptides, nucleic acids, etc) and combination drug products possess many of these same problematic obstacles that affect efficacy. These challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel drug delivery platforms that overcome a great many bioavailability and delivery obstacles. By leveraging these platforms, pharmaceutical and biopharmaceutical companies can improve dosing accuracy, efficacy, and reproducibility in their drug discovery and drug delivery research.
Drug Delivery System Demand
The demand for pharmaceutical products worldwide is only going to increase in the coming years, as old and emerging diseases continue to threaten the well-being of people globally. Drug discovery efforts are expected to intensify, generating a large variety of active compounds with vastly different structures and properties. However, it is well known that despite tremendous output of the drug discovery process, the success rate of a candidate compound becoming an approved drug product is extremely low. The majority of candidate compounds are discarded due to various hurdles in formulation and preclinical testing (such as issues with solubility, stability, manufacturing, storage, and bioavailability) before even entering into clinical studies. Therefore, advances in formulation and drug delivery, especially the development of new and versatile biomaterial platforms as effective excipients, may salvage many “difficult,” otherwise triaged, drug compounds, and significantly enhance their chance of becoming viable products. Furthermore, breakthroughs in biomaterial platform technologies will also facilitate life cycle management of existing APIs through reformulation, repurposing of existing APIs for new indications, and development of combination products consisting of multiple APIs.