PHARMACY MARKET
Nephron Pharmaceuticals Corporation | November 15, 2022
Nephron Pharmaceuticals Corporation and Sharps Technology, Inc. announced a brand new partnership focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the InjectEZ component of expansion.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in developing and manufacturing innovative drug delivery systems. Nephron Pharmaceuticals is known across the country to health systems and hospitals as a leader in the production of affordable generic inhalation solutions and suspension products, as well as pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags.
InjectEZ is part of the Nephron investment of hundreds of millions of dollars of expansion in Lexington County, S.C., over the last two years. Lou Kennedy, Nephron CEO, knows that when launching an endeavor as ambitious as InjectEZ, partnerships are key.
"We are excited to kick off a partnership with Sharps Technology, as our InjectEZ expansion project opens, for a variety of innovative initiatives, including research and development," said Kennedy. "Just as the InjectEZ syringe manufacturing facility is poised to play a critical role in assisting those with whom we work on tackling emerging public health crises, Sharps Technology also offers key solutions to healthcare challenges. We look forward to working with them."
Sharps product lines have historically focused on low waste and ultra-low waste syringe technologies, which allow up to 40% more injections per vial of therapy while incorporating multiple passive safety features. These features protect front-line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. The partnership with Nephron opens up opportunities for Sharps to expand its portfolio and make an impact on the specialized pre-fillable syringe and drug delivery systems market.
"Sharps Technology has identified a unique opportunity to collaborate with a leader in the industry like Nephron. Through my previous industry experience supporting and working with most of the leading healthcare and pharmaceutical companies in the world, it was easy for me to evaluate Nephron Pharmaceuticals as a potential partner. They truly are a leader in all areas of business and an example of best in class for the industry. I appreciate and look forward to the opportunity to work with Bill and Lou Kennedy and their leadership team to make this collaboration a success for both companies."
Robert Hayes, CEO of Sharps Technology
Sharps Technology brings extensive expertise in syringes to Nephron, including experience with specialized pre-filled syringe systems and ready-to-use processing. The pre-filled syringe lines will utilize the highly automated equipment and controlled environments established by Nephron. These premium pre-filled polymer offerings will be made from the highest quality raw materials, on the most innovative technology, and will be compliant with the USP standards required in the United States as well as the EP and JP international standards.
The products that will be developed and commercialized provide solutions to support the current Nephron fill/finish strategies as well as their pipeline of new drug applications and sets forward a strategy to support branded pharma and advanced therapies, including ophthalmic and biologic applications.
Sharps Technology will also be partnering with Nephron Pharmaceuticals in the development of a Pharmaceuticals Services Program designed to support healthcare customers that need innovative solutions and products to support their business. The development of this program will help create new fill/finish project opportunities for Nephron that will utilize innovative packaging solutions developed by Sharps Technology. These new customer projects will fuel the growth of both companies, and the opportunity to create new technologies to support the healthcare industry will be transformative for Nephron and Sharps as they navigate a bright future working together.
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PHARMACY MARKET
Jacobio Pharma | October 13, 2022
Jaco Jacobio announced it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor JAB-21822 and Merck's epidermal growth factor receptor inhibitor Erbitux®.
This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement.
"Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck,"
Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio
About JAB-21822
JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab.
About ERBITUX®.
ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells.
ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.
About Jacobio
Jacobio Pharma is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.
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PHARMA TECH
Alimentiv Inc. | October 06, 2022
Alimentiv Inc. Satisfai Health, Inc and Virgo Surgical Video Solutions, Inc. announced a strategic partnership to revolutionize central reading, data capture, decision support, and patient recruitment in the clinical trial domain for Inflammatory Bowel Disease and allied GI conditions. Satisfai, a global leader in developing artificial intelligence solutions for gastroenterology, and Virgo, an industry leader in endoscopy video capture technology, will leverage their combined strengths to work in partnership with Alimentiv, a leading CRO in gastroenterology, to realize the full potential of AI-powered precision imaging in the GI clinical trials space.
"This synergy of Satisfai and Virgo with Alimentiv is a positive development for patients with IBD and the drug development space. Clinical trials have many pain points, and this strategic partnership will enable advances in improving the efficiency of clinical trials and make some significant changes to how trials are run. We are delighted to enter this arrangement to bring the next generation of imaging technology to clinical trials in gastroenterology."
Jeff Smith, CEO of Alimentiv
"Artificial Intelligence in medicine is being increasingly adopted across various clinical specialties, with gastroenterology being one key field of use, particularly endoscopy," said Dr. Michael Byrne, CEO and founder of Satisfai Health, Clinical Professor of Medicine and gastroenterologist in Vancouver. "Working with Virgo, we are excited to bring AI-driven solutions to the IBD clinical trials arena. To be able to do so with Alimentiv — a leading Gastroenterology and imaging CRO—is a great opportunity. Our clear ambition is to change the clinical trial paradigm for IBD and other disease states such as Eosinophilic Esophagitis. As three groups working together, we are confident we can do so."
"Combining Satisfai's marquis AI solutions with Virgo's HIPAA and SOC 2 compliant automated cloud video capture technology and Alimentiv's 21CFR11 compliant solutions, expansive site community, and imaging expertise is very powerful. We truly look forward to realizing this vision and bringing real-time, in-line AI solutions to GI clinical trials worldwide," said Matthew Schwartz, CEO and co-founder at Virgo.
This partnership will facilitate Alimentiv's continued leadership in GI Clinical Trials through exclusive access to Satisfai's SmartScore Central Reading tool and Virgo's fully integrated, hands-free, cloud-based high-definition video-capture fleet. In addition, this will provide pharmaceutical and biotech sponsors with access to the ongoing development of novel endpoints, scoring methodologies, and scalable solutions geared toward bringing novel therapies to market faster.
About Alimentiv Inc.
Alimentiv is a global contract research organization (CRO) providing clinical trials, central image management, precision medicine, and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. The organization's unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in IBD. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and partners with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance IBD research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society.
About Satisfai Health
Satisfai is a leading medical solutions provider specializing in AI applications applied to large addressable markets in gastroenterology. Satisfai's solutions deliver real-time medical imagery analysis, providing clinicians with decision support intelligence that dramatically improves patient outcomes. Satisfai is supported by a highly respected board of medical clinicians and key opinion leaders who operate at the top of their fields in the many areas of gastroenterology. Satisfai enjoys a strong voice on academic panels, leading GI societies, and direct access to prominent industry players seeking to adopt new AI technologies in gastroenterology.
About Virgo
Virgo provides the leading cloud video capture, management, and artificial intelligence analysis platform for endoscopic medicine. Academic, integrated, and private practice healthcare providers use the Virgo platform to advance patient care through video-based research and training initiatives. Since launching, Virgo has helped physicians capture over 400,000 endoscopy procedures using industry-leading HIPAA, HITRUST, and SOC 2-compliant cloud service providers. Virgo also supports integration with all leading electronic health records systems. In 2021, Virgo launched a suite of tools called VirgoTrials, which help pharmaceutical trial sponsors and their participating trial sites accelerate patient recruitment and shorten the overall enrollment period for trials.
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