BUSINESS INSIGHTS, PHARMACY MARKET
Xeris Pharmaceuticals, Inc. | January 31, 2023
On January 30, 2023, Xeris Biopharma Holdings, Inc., a leading biopharmaceutical company, announced that the Food and Drug Administration (FDA) granted orphan-drug exclusivity (ODE) to its subsidiary Xeris Pharmaceuticals, Inc. for Recorlev® (levoketoconazole) a cortisol synthesis inhibitor for the treatment of endogenous Cushing's syndrome in adult patients for whom surgery is not viable or has not been effective.
levoketoconazole (Recorlev) being the first FDA-approved therapeutic for the treatment of endogenous hypercortisolemia, Xeris Pharmaceutical is permitted to have seven years of orphan-drug market exclusivity beginning from December 30, 2021. The FDA's Orphan Drug Designation program intends to accelerate the development of medications that treat a disease that affects 200,000 or fewer people in the United States each year. This regulatory exclusivity with the patent exclusivity under Xeris' U.S. patents for Recorlev is valid until at least March 2040.
To serve and assist this community, Xeris is dedicated to ensuring that everyone who needs access to their medications receives them. Xeris has developed Xeris CareConnection™ to provide patients and caregivers with a comprehensive program that includes financial support, one-on-one assistance, and educational materials throughout the treatment journey. Additionally, Xeris CareConnection assists healthcare providers and their teams with education on access and reimbursement.
About Xeris Pharmaceuticals, Inc.
Founded in 2005, Xeris is a growth-oriented biopharmaceutical firm dedicated to improving patients' lives via the development and commercialization of novel products in a range of therapies. Its unique technology makes medicines easier to use for patients & caregivers. The company has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for treating severe hypoglycemia (very low blood sugar); Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous hypercortisolemia. In addition, it has an increasingly broad pipeline of research and partnered projects utilizing its unique formulation technology platforms, XeriSol™ and XeriJect™, bringing forward innovative products for the firm and its partners.
BUSINESS INSIGHTS, VIEWS AND ANALYSIS
Rancho BioSciences | February 02, 2023
On February 1, 2023, Rancho Biosciences, a leading provider of data sciences services, announced that BenevolentAI has joined the SCDS consortium as its fifth member. Rancho Biosciences launched its Single Cell Data Science (SCDS) pre-competitive consortium on February 26, 2022, with four Charter Members: Bristol Myers Squibb, Janssen Research & Development LLC, a subsidiary of Johnson & Johnson's Janssen Pharmaceutical Companies, Novartis, and Vesalius Therapeutics.
The consortium's mission is to establish a uniform industry standard for creating and formatting single-cell datasets through a systematic effort to build data models and ensure that public data are curated consistently. Due to the evident impact of single-cell transcriptomics technology on drug discovery, pharmaceutical firms continue to adopt single-cell sequencing techniques at an exponential rate.
The availability of ever-increasing volumes of single-cell datasets in the public domain enables pharmaceutical companies to vastly increase their universe of single-cell experiments over those generated internally. However, harnessing this enormous public data lake by locating, downloading, and curating single-cell data is difficult and time-consuming compared to the resources required for scientists to analyze data to derive value for biomedical research collectively.
To date, Rancho has provided 83 analysis-ready datasets by using its extensive curation knowledge and expertise. Each dataset contains 79 columns of curated metadata that have been verified against a 4-entity data model developed by Rancho for SCDS. Based on member priorities, Rancho will continue to contribute a steady stream of harmonized single-cell datasets to the consortium. With this shared cost model, these may be supplied at a far higher throughput and much more cost-effectively than a single company could do.
About Rancho BioSciences
Founded in 2012, Rancho BioSciences is a global fee-for-service data curation firm that provides analysis and development services to clients, including pharma, foundations, government, and biotech. With a global team of qualified Ph.D. and Ph.D./MD scientists that provide high-quality work based on their expertise and domain knowledge in biology, diseases, and clinical data, it strives to find cures for diseases by serving its clients and saving lives through Data. It aims to be the world's leading provider of data services and harness domain skills and expertise to address complex problems.
BUSINESS INSIGHTS, PHARMACY MARKET
West Pharmaceutical Services, Inc. | February 01, 2023
On January 31, 2023, West Pharmaceutical Services, Inc., a global pioneer in novel injectable drug administration solutions, announced its participation in Pharmapack Europe 2023 in Paris, France, to demonstrate its leadership and insights on industry packaging and containment trends and challenges.
With the introduction of three new products, the company expands its innovations for its patients and customers worldwide - Daikyo Crystal Zenith® 2.25mL Insert Needle Syringe System, West Ready Pack™ with Corning Valor® RTU Vials using Stevanato Group's EZ-fill® SG EZ-fill® technology and FluroTec® 5-10mL Cartridge Plunger.
West Pharmaceutical Services Vice President and General Manager, Biologics Li Chen commented, "This year, we are introducing three new product solutions at Pharmapack." He added, "With these innovations, we are addressing the growing market needs for today's complex and sensitive molecules, including large-volume delivery and a complete vial containment solution that can protect and scale from development through commercialization."
(Source – PR Newswire)
Meanwhile, West's participation in this year's conference includes the following
Learning Lab - How Market Trends Drive Innovation and Enable the Pharmaceutical Pipeline on Wednesday, February 1, 2023
Panel Session - Innovation of Novel Medicines and Trends in Demand for Injectable Home and Self-Administration on Wednesday, February 1, 2023
Innovation Tours - West Ready Pack™ with Corning Valor® RTU Vials using Stevanato Group's EZ-fill® Technology on Wednesday, February 1, 2023
Daikyo Crystal Zenith® 2.25mL Insert Needle Syringe System on Thursday, February 2, 2023
About West Pharmaceutical Services, Inc.
Founded in 1923, West Pharmaceutical Services, Inc. is a market leader in developing and delivering innovative, high-quality injectable solutions and services. As a trusted partner to both established and emergent drug producers, it contributes to the safe, effective containment and distribution of life-saving and life-enhancing medications to patients. West Pharmaceutical supports its clients by supplying over 45 billion components and devices annually, with roughly 10,000 team members spread across 50 facilities globally. The company marks its 100th anniversary of growth and innovation in 2023, as well as the essential role it continues to play in healthcare and the patient experience. Headquartered in Exton, Pennsylvania, it had generated $2.83 billion in net sales for the fiscal year 2021.