NovaBay Pharmaceuticals | July 20, 2021
NovaBay Pharmaceuticals, Inc., a pharmaceutical firm focused on commercializing Avenova for the eye care market, has announced a collaboration with ImprimisRx, one of the nation's top ophthalmology-focused pharmaceutical companies, to promote prescription Avenova. ImprimisRx, a wholly-owned subsidiary of Harrow Health, Inc., will offer national sales, marketing, and distribution support for NovaBay's FDA-cleared 0.01% hypochlorous acid Avenova in 40 ml bottles. Avenova is a clinically approved antimicrobial lid and lash solution used to treat various chronic eye conditions.
Avenova serves a large and rapidly growing dry eye market, with 30 million Americans suffering from chronic eye diseases such as blepharitis and meibomian gland dysfunction. It is the only lid and lash spray made with NovaBay's patented pure hypochlorous acid and is suitable for daily usage. In addition, Avenova is usually prescribed by ophthalmologists and optometrists before and after cataract and Lasik procedures, making it a complementary therapy for many ImprimisRx's existing products.
ImprimisRx is one of the nation's top ophthalmology-focused pharmaceutical companies, with 40 proprietary ophthalmic formulations serving thousands of ophthalmologists and optometrists throughout all 50 states.
About Harrow Health
Harrow Health, Inc. is a healthcare company specializing in ophthalmology. ImprimisRx, the leading ophthalmology-focused pharmaceutical company, and Visionology, a direct-to-consumer eye care subsidiary focusing on chronic eye disease, are owned and operated by the company. Harrow Health also owns stakes in Eton Pharmaceuticals, Surface Ophthalmics, and Melt Pharmaceuticals, all of which began as Harrow Health subsidiaries. Harrow Health also has royalty rights to four clinical-stage drug candidates developed by Surface Ophthalmics and Melt Pharmaceuticals.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focused on high-quality, differentiated anti-infective consumer products such as Avenova, the top antimicrobial lid and lash spray, CelleRx Clinical Reset, a game-changing product in the beauty category, and NeutroPhase Skin and Wound Cleanser for wound healing. NovaBay products include its patented, pure, stable, pharmaceutical-grade hypochlorous acid, replicating the antimicrobial chemicals used by white blood cells to combat infection. NovaBay's hypochlorous acid products cause no stinging or irritation, are nontoxic, and are non-sensitizing, making them entirely safe for daily usage. In addition, Avenova is the first commercial hypochlorous acid lid and lash spray product that has clinically proven to reduce bacterial load on ocular skin surfaces, effectively addressing the underlying cause of bacterial dry eye.
Spotlite360 | July 07, 2021
SPOTLITE360 TECHNOLOGIES, INC. is happy to announce that it has started an initiative to provide tailored supply chain tracing and tracking solutions for pharmaceutical companies, for which it is now in contract discussions with pharmaceutical firms. This effort coincides with an impending regulatory shift in the USD 1.3 trillion pharmaceutical industry1 that will require companies to comply with the Drug Supply Chain Security Act (“DSCSA”), which requires the deployment of electronic tracing systems. The Company has recognized an opportunity to offer solutions to DSCSA compliance by combining RFID and IoT sensors with blockchain, machine learning, and enterprise tracking software licensed from TrackX Holdings Inc.
In addition to the cost of complying with new and upcoming laws such as the DSCSA, pharmaceutical sector participants confront the following persistent difficulties in their supply chains:
• Every year, about USD 200 billion in counterfeit medicines are sold worldwide.
• Pharmaceutical cargo theft costs more than USD 1 billion per year, with a median stolen value of USD 100,000 being more than the industry average.
• Inadequate storage and transportation practices (e.g., unrefrigerated trucks, shipment periods that exceed a drug’s shelf life) can cause pharmaceutical damage, which has been highlighted as a multibillion-dollar issue in 2018.
The Company’s existing SaaS solution, powered by Spotlite360 technologies tailored to clients in the pharmaceutical industry, will capture real-time and event-driven data that can identify inefficiencies and potential hazards for pharmaceutical firms, potentially mitigating issues such as those listed above. Furthermore, potential benefits to clients in the pharmaceutical industry include accountability of global suppliers, as well as validation of claims relating to environmental, social, and corporate governance (“ESG”) matters by providing proof of origin, reliably authenticating goods, and allowing visibility into the chain of custody.
Blockchain technology has already shown to be effective in various pharmaceutical supply chain functions, including DSCSA compliance. In 2020, a major technology company released a study of its blockchain pilot program in collaboration with pharmaceutical behemoth Merck & Co. and the United States Food and Drug Administration (“FDA”), which was judged initially viable as stated in its final report filed to the FDA5. Spotlite360’s newest effort for the pharmaceutical sector aims to set new industry standards by providing an improved value proposition through full visibility and tracking capabilities.
About Spotlite360 Technologies Inc.
Spotlite360 is a logistics technology solutions provider that unlocks value, opportunities, and efficiency for all supply chain participants. Spotlite360 aims to establish new standards of transparency, integrity, and sustainability in the pharmaceutical, healthcare, and agriculture industries by building on existing applications of IoT technology, distributed ledgers, and machine learning. As authorities worldwide continue to enforce additional tracing and accountability requirements for consumer protection, the need for dependable, cost-effective, and flexible monitoring technology is anticipated to grow. Spotlite360’s flagship SaaS solution has been designed to monitor the movement of a product in real-time by connecting with the systems of all major stakeholders in the supply chain, from raw materials to the hands of the end customer.
WuXi Biologics | June 06, 2022
WuXi Biologics a global CRDMO service company, announced it has successfully launched the GMP operation of its new drug product facility DP5 located in Wuxi, China. The DP5 is the ninth operational drug product facility in the global network of WuXi Biologics.
The DP5 facility features an advanced isolator filling line for continuous and steady filling services, which offers multiple volume delivery options for pre-filled syringes including 1 mL Long, 1 mL, 2.25 mL and 3 mL. The maximum filling speed can reach 400 PFS/min to support 17 million syringes of drug products manufacturing every year. The increased manufacturing capacity at DP5 allows WuXi Biologics to provide global partners with faster and more robust end-to-end drug product services for their innovative products at different scales and stages.
Compared to a traditional drug product filling line, DP5's state-of-the-art design and layout, single-use technology and automated equipment, significantly decrease the risk of contamination and maintain aseptic control required in the filling process. This process supports clients' products scale up to commercial capability and reliably delivers to patients under the highest quality standards which WuXi Biologics represents.
"Pre-filled syringes have emerged as one of the fastest-growing choices for biologics dosage form as our partners seek new and more convenient biologics delivery methods. The GMP operation of DP5, our first commercial drug product facility for pre-filled syringes, not only demonstrates our commitment to global partners, but also marks an important milestone for WuXi Biologics to become one of the global leaders in drug product CDMO services. We'll continue to enable our clients to advance innovative biologics towards clinical trials, regulatory approvals, and commercialization to benefit patients worldwide."
Dr. Chris Chen, CEO of WuXi Biologics
About WuXi Biologics
WuXi Biologics is a global Contract Research, Development and Manufacturing Organization offering end-to-end solutions that enable partners to discover, develop, and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 10,000 skilled employees in China, the United States, Ireland, Germany, and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development, and manufacturing solutions. As of the end of 2021, WuXi Biologics is supporting over 480 integrated client projects, including nine in commercial manufacturing.