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Press Releases from Greystone Research Associates (106 total)

Seeking to Capitalize on New Device Technology Drug Companies are Reformulating …

(Amherst, NH) – As the pace of competition increases within the pharmaceutical and biotech industries, the concept of life cycle management is becoming a key component of drug product management. Much of the recent emphasis in this area has centered on efforts to extend patent rights protection. While reformulation has been and is an important approach, efforts to prolong IP benefits have only recently involved IV-to-SC drug re-engineering. This migration

Antibacterial Treatments that don’t Rely on Antibiotics Winding their way thro …

(Amherst, NH) – As bacteria grow resistant to conventional antibiotics, alternatives are being investigated, including antibodies, probiotics, bacteriophages, and antimicrobial peptides. The quest to replace the current generation of antibiotics is complicated by the methods that bacteria have acquired to evade attempts to destroy them – methods often referred to a virulence factors. A microorganism can possess a wide array of virulence factors. They may only express these virulence factors when

3D Printing Positioned to Address Issues that have Prevented Wide Adoption of Mi …

(Amherst, NH) – The promise of commercial microneedle drug delivery has been on the horizon for more than a decade. Like other compelling medical device innovations such as noninvasive glucose monitoring, the potential of the technology has yet to be realized due to the inability to solve the issues of reliable product performance from unit to unit and across a wide user population. To fully address the unmet need these technologies

Analysis of the Oncology Drug Pipeline Reveals Evolving Therapy Correlations and …

(Amherst, NH) – The almost two thousand active oncology clinical trials paint a picture of an evolving therapeutic sector that has established players moving quickly to realize the expanded benefits of recent treatment protocols. A dozen targeted treatments, using novel pathways and signaling, have achieved results that represent a new era in oncology and antineoplastic therapeutics. There approaches have attracted a growing number of drug developers anxious to profit from

For Injectable Drugs Wireless Connectivity Allows Caregivers to Manage Patients …

(Amherst, NH) – The growing emphasis on drug self-administration is having a major impact on the pharmaceutical industry. The aging population and managed care initiatives are major forces driving the growth of home healthcare, a trend that includes the self-administration of drug therapies for chronic conditions such as diabetes, arthritis and hormone replacement therapy. This trend is creating an increased demand for medical devices that are patient-friendly and cost-effective. Much

Responding to Competitive Factors Drug Injection Device Suppliers Continue to In …

(Amherst, NH) – As pharmaceutical companies struggle to position their products in the direct-to-consumer marketing era, the trend toward combining functionality and packaging in drug delivery systems is growing. Innovative drug delivery systems allow pharmaceutical companies to differentiate drug products from competitors. This is essential at a time when many patents are running out and competition among the manufacturers of generic medicines is increasing. As new injectables receive marketing approval,

Biological Autoimmune Therapeutics Continue to Grow as Patients and Caregivers S …

(Amherst, NH) – The administration of therapeutic immune modulators is becoming an increasingly important healthcare treatment option for a growing number of diseases and indications having broad implications for patient health and well-being. But to fully exploit the value of this class of therapeutics in both human and commercial terms, developers must successfully navigate the inherent limitations of drug storage and administration, moving away from infusion and toward injection as

Uptake of Autoimmune Injectables Aided by Delivery Device Evolution

(Amherst, NH) – Autoimmune diseases, a group of chronic ailments that includes arthritis, psoriasis, lupus, and multiple sclerosis, afflict tens of millions of people worldwide and result in levels of morbidity that can significantly impact quality of life and longevity. They represent some of the most difficult therapeutic challenges facing the healthcare community. The refractory nature of this family of diseases is rooted in the complexities and genetic underpinnings

Patient Enablement and Immunotherapeutic Drug Self-Dosing

(Amherst, NH) – The administration of therapeutic immune modulators is becoming an increasingly important healthcare treatment option for a growing number diseases and indications having broad implications for patient health and well-being. But to fully exploit the value of this class of therapeutics in both human and commercial terms, developers must successfully navigate the inherent limitations of drug storage and administration, moving away from infusion and toward injection as a

Injection Device Design Evolution a Key to the Growth of Biological Drugs

(Amherst, NH) – Because of their ability to effectively treat refractory conditions by targeting specific biomarkers, biological drugs continue to be at the forefront of modern drug development. By focusing on interactions at the cellular level, biologicals provide relief to patients afflicted with chronic conditions. The need for ongoing treatment places a strong emphasis on the ability of biological drugs to be designed and packaged for self-administration by the patient,

Handheld Devices for Injecting Viscous Drugs Becoming a Defined Market

(Amherst, NH) – The high value, proliferation and properties of biological drugs are creating opportunities and challenges for device developers. In particular, sector participants are attempting to address the issue of high viscosity, and in the process are extending the design envelope for needle-based injectors. These companies are attempting to accommodate a range of viscous drugs that extend from 20 to over 1000 cP. The five categories of handheld injection

Sustained Release Injectable Drugs Filling an Unmet Need by Extending Dosing Int …

(Amherst, NH) - For many chronic and refractory conditions, the need for frequent and continual drug injections is a therapeutic necessity, one that can be accompanied by harsh side effects and safety issues that often lead to erosion in patient compliance and therapeutic outcomes. While the pharmaceutical industry has made significant progress in developing and introducing extended release formulations of orally administered drugs, the complexities associated with injectables go

Unprecedented Market Exits a Reality Check for Measuring Glucose Noninvasively

(Amherst, NH) – Very few medical device markets can claim to exceed noninvasive glucose monitors (NGM) for marketing hype, product pronouncements and unkept promises. Fueled by patient enthusiasm and investor amnesia, this market has survived a long string of missed deadlines, perpetually postponed milestones and re-designed web sites. Along the way, one by one most participants have become casualties. In the ten years since we first began to track noninvasive

Strategies for Injectable Drug Managers Require Multidimensional Metrics as Mark …

(Amherst, NH) – There are currently over 1,900 approved injectable drugs across all application types (BLA/NDA/ANDA). Approved injectable drug applications have been average 70 per year over the past five years. Analysis of the current drug pipeline indicates that this trend will not be slowing going forward. Market sector participants are seeking business leverage in several areas, primarily in the area of generic injectables, where uneven dosing coverage can present

On-Body Subcutaneous Injection Systems Positioned to Prosper as Dosage Volumes P …

(Amherst, NH) – As drug developers widen the therapeutic envelope to create effective treatments for intractable disease targets, they are finding it necessary to move beyond traditional limits on drug formulation and dosing. The result is often specified doses that are beyond the acknowledged limit of 1-2 mL for subcutaneous injections. Device designers have introduced a solution in the form of injectors with reservoirs typically ranging from 5 to 20

Dual Chamber Injection Device Market to Reach $5.3 Billion by 2024

(Amherst, NH) – The need to reconstitute lyophilized drugs at the point of administration and the potential safety and compliance issues this represents for patients have led to increasing interest in injection devices that can eliminate the number of steps required to convert the drug powder to liquid form and make it available for injection. Dual chamber syringes and injectors – devices that allow reconstitution to take place within the

Converging Factors Driving the Growth of Transdermal Patches for Neurology Indic …

(Amherst, NH) – Despite recent progress in a number of therapeutic sectors, progress toward curative medicine for neurological and related central nervous system disorders has remained elusive. The result is a therapeutic sector that relies heavily on control of symptoms and palliative care. This disappointing picture is being exacerbated by disease trends that are increasing the morbidity and mortality associated with CNS ailments in the general population. These trends include

Microchips Accelerating the Evolution of Drug Device Sophistication

(Amherst, NH) - As therapeutic drug markets continue to evolve, advancements in drugs and devices are producing several positive improvements. New formulations are extending drug release profiles, leading to less frequent dosing. Enhancements in syringe and injector usability are increasing the number and types of therapeutics that can be self-administered. These advances have revealed a new set of concerns. Weekly, bi-weekly and monthly dosing deprives the patient of the repetitive

Unmet Need Remains for Subcutaneous Sustained Release Injectables

(Amherst, NH) - As patients live longer and the prevalence and incidence of chronic ailments increase across the general population, drug developers and their delivery device partners are adapting to address what will become a significant market opportunity. Chronic conditions require drug administration over long periods of time, placing a greater emphasis on self-administration and reduced dosing frequency. With the shift away from caregiver interaction, drug safety and compliance/adherence

Drug Developers Look to Deuterated Drugs as Risk Managed Opportunity

(Amherst, NH) – Interest in deuterated drugs – drugs in which carbon-hydrogen bonds have been replaced with carbon-deuterium (heavy hydrogen) bonds - has been increasing as drug companies seek to shorten the path to market by modifying existing APIs that have established clinical value. The ability of developers to employ formulation technology to substitute deuterium atoms into an existing drug molecule is seen as a way to lower drug development

Closed Transfer Systems for Hazardous Drugs Preparing for Change as New Standard …

(Amherst, NH) – In the specialized area of oncology, the use of substances that can harm as well as benefit is common. The danger extends to hospital pharmacy compounders and caregivers, as well as the patient. A specialized area of drug handling systems known as closed system transfer is comprised of a small number of devices that are designed to protect workers and patients by limiting exposure to harmful substances

As Self Administered Injectables Expand Drug Companies Attempt to Capture the Pa …

(Amherst, NH) – The rapidly increasing number of drugs being developed for administration through the skin is fostering a growing supply chain infrastructure for injectable delivery devices designed for self administration by the patients themselves. These devices have been designed to address the accelerating number of drugs that must be introduced through the skin via subcutaneous injection due to their size or limitations or their inherent instability. Drugs in this

Converging Factors Driving the Growth of Dry Powder Inhaled Delivery

(Amherst, NH) – The search for improved routes of administration for therapeutic agents and the desire for noninvasive delivery methods for self-medication of chronic conditions have led to increased interest in pulmonary drug delivery systems. Recent developments, including ongoing research activity in powder formulations, advances in particle engineering, and novel device architectures are positioning dry powder inhalation as an attractive option for pharma and biotech product strategists in this age

Wearable Patch Pumps that Deliver Drugs Subcutaneously Filling an Unmet Need

(Amherst, NH) – As the number of patients diagnosed with chronic diseases continues to grow, the pharma and biotech industries are rising to address the therapeutic needs of these patients by developing and manufacturing new drugs based on new NCEs (New Chemical Entities) – powerful drugs that treat conditions in new and novel ways. At the intersection of these two trends is the need to self-administer powerful and effective drug

Generic Oral Liquid Drug Dosage Forms Evolving as Competitors Seek Opportunities

(Amherst, NH) – The generic oral liquid dosage form drug segment is a rapidly evolving and fluid environment that has been a challenge to decision makers attempting to map strategies for success in this segment. Generic drugs are re-shaping the pharmaceutical industry, and the pace of activity shows no signs of slowing. There are currently 309 distinct APIs for which there is at least one approved generic oral liquid dosage

As the Industry Evolves the Recombinant Drug Sourcing Landscape Reflects Pragmat …

(Amherst, NH) – In recent years, the number of biological drugs - approved and in development - has increased significantly. The pace of this growth is encouraging suppliers to view competitors in new ways. Cooperation between and among drug developers and drug producers is occurring much earlier in the drug development cycle, allowing participants to improve supply chains and time-to-market. The result is an ecosystem that is often the blend

Vaccines Delivered by Microneedles to Reach $440 Million by the End of the Decad …

(Amherst, NH) – The global market for microneedle-delivered prophylactic vaccines reached US $210 million in 2016 and is expected to increase 20 percent annually, exceeding $440 million in 2020. Growth over the period will be focused in North America and Europe and will be driven primarily by syringe-mounted single microneedle combination products. Although impressive, this market has yet to attain breakout status. In spite of the recognized advantages of microneedles for

Handheld Devices that Target High Viscosity Drugs Expected to Benefit from Biolo …

(Amherst, NH) - As biologicals continue to dominate the drug development landscape, their impact on the healthcare industry is beginning to be felt in unexpected ways. This class of drugs is primarily comprised of very large molecules that result in high viscosities, or resistance to flow. As a result they often must be delivered via IV infusion. The increase in new drug approvals that require IV administration will soon begin to

Wirelessly Enabled Injection Devices Keep Patients Connected to Caregivers as Ho …

(Amherst, NH) – As the number of patients who self-administer injectable drugs continues to grow, adherence to drug therapy and disease management protocols have become a primary concern within the healthcare and pharmaceutical industries. For chronic conditions adherence has a direct effect on the patient’s quality-of-life. Efforts to enhance adherence have a non-negligible effect on drug formulations and delivery decisions, and are a significant factor in the prescribing decisions of

Infusion Medication Management Systems a Key Initiative for Improving Patient Sa …

(Amherst, NH) – Infusion is one of the most common in-patient procedures. So perhaps it’s not surprising that infusion devices are the subject of more adverse incident reports to the FDA than any other medical technology. Improving the safety of infusion and infusion products has been and continues to be a priority for the industry, caregivers and healthcare administrators. While infusion pumps and vascular access components have improved in quality

Despite Progress Injectable/Infusible Antimetabolites Remain the Workhorse in Ca …

(Amherst, NH) – The world of oncology continues to evolve as physician specialists and researchers apply the latest knowledge and therapies to treat patients afflicted with cancer. Several advances have prolonged survival and provided hope to patients and their loved ones. Targeted drugs - typically monoclonal antibodies that bind to a specific cell surface receptor to affect a therapeutic response – have produced many success stories in treating

Despite Research Efforts Ten Injectable APIs Continue to Anchor the Injectable A …

(Amherst, NH) – For many chronic and refractory conditions, the need for frequent and continual drug injections is a therapeutic necessity, one that can be accompanied by harsh side effects and safety issues that often lead to erosion in patient compliance and therapeutic outcomes. While the pharmaceutical industry has made significant progress in developing and introducing extended release formulations of orally administered drugs, the complexities associated injectables go

Despite Incremental Improvements, the Promise of Smart Infusion Remains an Elusi …

(Amherst, NH) – Infusion remains one of the most common in-patient procedures and a technology that has been around for decades, yet the nature of IV drug delivery continues to be a major source of errors – one that appears to be refractory to industry efforts to eliminate them. While other healthcare segments have been quick to see significant gains from the uptake of evolving technologies such as miniaturized electronics,

Connected Drug Delivery Represents a New Element in Personalized Medicine

(Amherst, NH) – Wireless technologies for drug delivery have been explored in novel platforms for the past decade. But it’s only been recently that wireless capabilities have been incorporated into commercial drug devices. Much of the activity surrounding connected drug delivery is focused on chronic diseases – conditions where the ability of caregivers to access data on patient self-administration activities, patient reported outcomes, and feedback on the user experience can

Transdermal Prescription Gels Finding Opportunity in Niche Aging Markets

(Amherst, NH) – There are currently more than three dozen approved transdermal prescription gel drug products. Transdermal gel systems for delivering systemic therapeutics are attractive to drug developers and formulators because they address some of the shortcomings associated with transdermal patch products. Advances in the areas of excipients, drug solubility and transdermal dosing are attracting new players and investors. Growth in this sector will also be driven by the pressure

Collaborations and Alliances Increasing as the Market for Prefilled Syringes Mat …

(Amherst, NH) – The administration of therapeutic drugs via injection is an indispensable delivery method for numerous drugs critical to patient health and well-being. Now this segment is evolving in response to changing market conditions, increased competition from generics, consolidation within supply chains, and healthcare administration initiatives. The injectable drug ecosystem consists of several segments that include syringe component suppliers, syringe manufacturers, and contract filling companies. Within these layers are specialty

Generic Solid Dosage Forms Maintain their Rapid Rate of Expansion

(Amherst, NH) – Generic drugs are re-shaping the pharmaceutical industry, and the pace of activity shows no signs of slowing. Nowhere is the rate of change happening more quickly than in solid dosage forms. Because of the relatively low barriers to entry, generic solid dosage forms – better known as tablets and capsules – are outstripping all other drug categories in terms of market authorization approvals. In the year 2000,

Connected Oral Inhalers Latest Attempt to Improve Patient Self-Administration of …

(Amherst, NH) – Upper respiratory tract (URT) conditions including asthma and chronic obstructive pulmonary disease (COPD) continue to be a health segment that presents challenges to the caregiver community. Patient adherence with prescribing instructions and treatment protocols remains sub-optimal across all patient categories, but particularly for the young and the elderly. This has led to significant interest on the part of device and product providers toward the development of connected

Propelled by Innovative Devices Patient Self-Administration is Transforming the …

(Amherst, NH) – Rapid changes in the therapeutic drug sector are challenging pharmaceutical developers in a number of functional areas. In this mix are the evolving transformations within the healthcare systems and services segment, the escalating presence of biologicals in both revenue and total drug count, the transition from traditional caregiver models to self-dosing, and the influence of direct-to-consumer marketing on promotional programs. One major effect of these trends is

As Therapeutic Protein Market Grows, the Importance of Point-of-Care Strategies …

(Amherst, NH) – Led by the proliferation of antibody-based drugs and candidates, biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. This shift away from small molecule drugs is creating opportunities for drug developers, device designers, packagers and pharmaceutical marketers. Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by

Immune Modulators Continue to Dominate the Recombinant Drug Landscape

(Amherst, NH) – The role of the immune system in maintaining human health and disease prevention is now understood to include its impact on numerous cellular processes and pathological mechanisms. Pharma and biotech suppliers are responding to the related healthcare implications by focusing increasing resources on biological drugs developed to treat immune-related targets, resulting in a global market that is expected to exceed $55 billion in 2016. There are currently about

Injection Device Suppliers Introducing New Designs at a Record Pace

(Amherst, NH) – The proliferation of syringes and injectors for administering injectable drugs is occurring at a rate that is unprecedented in the history of the pharmaceutical market sector. There are currently more than ninety branded syringes and injectors in the global commercial marketplace, with new devices being introduced monthly. The growing importance of therapeutic drugs that are developed for administration via injection is fostering an evolving ecosystem of designers,

Drug Companies Re-positioning Intravenous Drugs for Subcutaneous Delivery

(Amherst, NH) – The number of drugs based on biologicals continues to grow at an increasingly rapid rate. Because of their physical properties and the relatively high administration volumes often required to achieve the desired therapeutic effect, the majority are developed and launched for intravenous administration. This is creating a burgeoning demand for infusion facilities, personnel and equipment. The relative complexity, costs and patient logistics associated with IV infusion relative

Small Form Factor Device Simplicity Propelling the Adoption of Self-administered …

(Amherst, NH) – In terms of developer interest and market activity, small form factor subcutaneous infusion (SFFSI) devices are reaching a tipping point that is forcing the industry at-large to take notice and re-assess their product strategies accordingly. While there are currently two dozen products launched and in development, the presence of large pharmaceutical companies in this space and the strategic agreements in place with key SFFSI device developers indicates

Microneedles Pursuing Patient Monitoring and Diagnostics Markets

(Amherst, NH) – Microneedle technology is attaining commercial viability at a time when healthcare providers are faced with new challenges as they assess ways to incorporate companion diagnostics into treatment protocols and medical practice areas. Microneedle technology has the potential to address the growing trend toward point-of-care diagnostics and ambulatory patient monitoring by allowing the precise detection of biomarkers and analytes in fluids and tissues located in or near the

As Therapeutics and Demographics Converge Developers Seek to Deliver Drugs in Hi …

(Amherst, NH) – As the trend favoring biological drugs as a percent of all drugs continues, the number of injectables that exceed 1 mL per dose, the de facto limit for comfortable and safe patient self-administration, is also increasing. Drugs that require dosing in higher volumes are typically infused in a healthcare setting. Managed care providers and healthcare strategists have taken notice and several foresee a changing healthcare delivery landscape

Integrated Devices for Reconstituting Injectables Creating Options for Drug Deve …

(Amherst, NH) – Therapeutic proteins must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed. Alternatively, proteins can be formulated as powders (lyophilization) and must be reconstituted prior to injection. Historically, this has been accomplished by including a disposable syringe and diluent vial for manual reconstitution. As the number of drugs

Pace of Change Makes the Market for Generic Injectables a Moving Target

(Amherst, NH) – Along with the ability to create therapeutic replicas of biochemicals via host systems, the emergence and proliferation of generic drugs continue to re-shape the therapeutic landscape. Generics have grown from a cottage industry two decades ago to a burgeoning subset of the pharmaceutical sector. The pace of activity in generics has centered on oral dosage forms. The next new hot market is injectables. There are 235 distinct APIs

Connected Skin Patches Ushering in a New Era of Personal Data

(Amherst, NH) – The ability to monitor movement, position, processes, physical parameters, analytes, and orientation using low-cost electronics in a small package that self-attaches to the data source is opening up channels to information that were not previously attainable. Stakeholders - researchers, caregivers, individuals, consignees – are re-thinking fitness routines, therapeutic protocols, investigational project strategies, and business models to account for the coming availability of data that presents new opportunities

Sustained Release Injectable Drugs Filling an Unmet Need by Extending Dosing Int …

(Amherst, NH) - For many chronic and refractory conditions, the need for frequent and continual drug injections is a therapeutic necessity, one that can be accompanied by harsh side effects and safety issues that often lead to erosion in patient compliance and therapeutic outcomes. While the pharmaceutical industry has made significant progress in developing and introducing extended release formulations of orally administered drugs, the complexities associated with injectables go

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