Drug Delivery
Catalent Signs Agreement to Acquire Juniper Pharmaceuticals
Catalent, Inc. recently announced it has agreed to acquire Juniper Pharmaceuticals, Inc., including its Nottingham, U.K.-based Juniper Pharma Services division. When combined with Catalent’s existing…
Biologic Excipients Market Expected to be Valued at $1.7 Billion by End of 2028
Future Market Insights (FMI) delivers key insights on the global biologic excipients market in its upcoming report titled Biologic Excipients Market: Global Industry Analysis 2013–2017 and Opportunity Assessment…
Atossa Genetics Completes All Dosing & Clinical Visits in its Study of Topical Endoxifen
Atossa Genetics Inc. recently announced it has completed dosing and clinical visits in its Phase 1 study of its proprietary topical Endoxifen in men. “We…
Celyad Doses First AML Patient at Final Dose Level in CYAD-01 THINK Trial & Begins Dosing First Patient With Second Cycle of Therapy
Celyad recently announced the first Acute Myeloid Leukemia (AML) patient was dosed with the first injections at the third and final dose level of CYAD-01…
Epinephrine Nasal Spray in Development for Treatment of Anaphylaxis Shows Promise as Potential Alternative to Intramuscular Injection
INSYS Therapeutics, Inc., a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that its investigational epinephrine nasal spray showed promise in an early clinical trial as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for the treatment of anaphylaxis.
Nutriband Signs LOI to Acquire Carmel Biosciences
Nutriband Inc. recently announce it has signed a Letter of Intent to acquire 100% of Carmel Biosciences, a pharmaceutical company that addresses critical needs in…
Axovant Licenses Investigational Gene Therapy for Parkinson’s Disease From Oxford BioMedica; Announces Key Leadership Team Addition
Axovant Sciences recently announced that it has licensed the exclusive worldwide rights to develop and commercialize OXB-102, now AXO-Lenti-PD, from Oxford BioMedica. AXO-Lenti-PD is an investigational gene therapy for Parkinson’s disease that delivers three genes encoding a critical set of enzymes required for dopamine synthesis in the brain.
Elite Pharmaceuticals Announces Strategic Marketing Alliance With Glenmark Pharmaceuticals
Elite Pharmaceuticals, Inc recently announced the signing of a license, manufacturing, and supply agreement with Glenmark Pharmaceuticals, Inc., USA to market two Elite generic products…
FDA Accepts Larotrectinib NDA & Grants Priority Review
Loxo Oncology, Inc. recently announced the US FDA has accepted the company’s New Drug Application (NDA) and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion
Amunix Announces Report by Bioverativ on Unprecedented Half-Life Obtained in Patients Treated With Novel, Long-Acting FVIII Utilizing XTEN Technology
Amunix Operating Inc. recently reported that Bioverativ (a Sanofi company) has announced preliminary Phase 1/2a safety and pharmacokinetic clinical data for BIVV001 (rFVIIIFc-VWF-XTEN), a novel and investigational factor VIII therapy for people with hemophilia A that incorporates Amunix’s XTEN technology to improve circulatory half-life.
Bioasis & WuXi Biologics Announce Initial Strategic Development & Manufacturing Collaboration
Bioasis Technologies, Inc.andWuxi Biologics recently announced an initial strategic collaboration for the development and manufacturing of xB3-001, Bioasis’ lead investigational biological candidate to treat brain cancer.
MimiVax Announces Positive Interim Results from Phase II Trial of SurVaxM
MimiVax LLC recently announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM).
Nabriva Therapeutics Announces Positive Topline Results From Pivotal Phase 3 Clinical Trial of Oral Lefamulin
Nabriva Therapeutics plc recently announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, the second of two global, pivotal Phase 3 clinical trials of lefamulin. LEAP 2 evaluated the safety and efficacy of 5 days of oral lefamulin compared to 7 days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).
Beta Bionics Receives IDE Approval From the FDA to Begin a Home-Use Clinical Trial Testing the a New Bionic Pancreas System
Beta Bionics, Inc. recently announced it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D).
NanoBio Announces Corporate Name Change to BlueWillow Biologics & Closes $10-Million Financing
NanoBio Corporation recently announced it has changed its corporate name to BlueWillow Biologics in conjunction with the closing of a $10-million Series A financing.
Bellerophon Reaches Agreement With FDA on Study Design of Phase 2b Trial
Bellerophon Therapeutics, Inc. recently announced that, following the receipt of minutes from a recent meeting with the US FDA, the company has reached agreement with the FDA on all key aspects of its planned Phase 2b study of INOpulse for the treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (PH-COPD).
Flexion Therapeutics Presents Updated Results from Clinical Trial
Flexion Therapeutics, Inc. recently announced updated interim findings from its ongoing Phase 3b, open-label study to evaluate the overall safety and general tolerability of repeat administration of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in patients with osteoarthritis (OA) of the knee.
Amerigen & Dipharma Announce Approval of First Generic of Miglustat
Amerigen Pharmaceuticals Limited and Dipharma S.A. recently announced that Amerigen’s Abbreviated New Drug Application (ANDA) for Miglustat 100 mg capsules has received final approval from the US Food and Drug Administration.
RenovoRx Announces $10-Million Financing for Innovative Treatment for Advanced Pancreatic Cancer
RenovoRx, Inc., a medical technology company developing an innovative catheter-based approach to treating pancreatic cancer, recently announced a $10-million financing round of which the company…
AIT Therapeutics Presented Data From Inhaled Nitric Oxide Study
AIT Therapeutics, Inc. recently announced the results of its study titled Nitric Oxide Inhalations in CF Patients Infected with Mycobacterium Abscessus Complex: A Prospective, Open-Labeled Multi-Center Pilot Study at the 2018 American Thoracic Society (ATS) Conference in San Diego, CA.
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.