Aizon | February 02, 2021
Aizon launches its Bioreactor Application, the pharma industry's first predictive analysis and profound knowledge management application. The Aizon Bioreactor Application adds the bioreactor process to the "Smart Manufacturing" transformation that is accelerating across the Pharma and Biotech industry. Aizon is extraordinarily able to achieve GxP compliance and give an audit trail from the start of the process. The turnkey application allows pharmaceutical and biotech companies to leverage rich datasets generated during upstream manufacturing to identify and accurately anticipate deviations and results potentially leading to countless dollars in expense savings, diminished danger, and additional income potential gain.
Intended to work with both persistent and took care of batch bioreactors, the Aizon Bioreactor Application gives a profound understanding of the client's bioprocess manufacturing lifecycle. The application leverages specialized Edge AI and contextualization, which is a prerequisite to make the data actionable. Contextualized data is harnessed, analyzed, and visualized through a persona-based lens for faster root cause analysis (RCA), real-time monitoring, and predictive insight across any number of bioreactor units and manufacturing sites.
AI models for bioreactor analytics are ready for use within the application or can be configured by customers within the GxP cloud-based application. “It is clear that biotech and pharmaceutical companies need an accessible, industry-specific tool that accelerates their path to value. Customers seek a seamless way to analyze complex data sets in real-time and to predict with accuracy the yield from bioreactor units that span multiple sites and global regions,” said Pep Gubau, CTO, Aizon. “Biotech and pharmaceutical companies can now more easily leverage the power of AI/ML in a GxP environment with an end-to-end lifecycle governance of data, models, and applications in order to understand and optimize bioreactor processes in commercial manufacturing.”
Aizon’s CEO, John Vitalie adds, ”Our focus is to empower customers to innovate and rapidly achieve their targeted outcomes without the overhead burden of tracking changes, revalidation, and on-going development to maintain compliance. By building the process knowledge framework, compliance, and scalability into the application, customers benefit significantly from the streamlined industrialization of their digital solutions. We see that this is key for pharma and biotech to realize the vision of smart manufacturing and accelerate their progress toward realizing the promise of the adaptive plant.”
Aizon is an enterprise software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within Pharma and other highly regulated industries. The Aizon AI platform and native GxP based applications seamlessly integrate unlimited sources of structured and unstructured data to deliver actionable, real-time insights across all manufacturing sites. Aizon brings deep domain expertise and works closely with Global System Integrators and technology partners to provide enterprise solutions to customers.
Two Labs | July 08, 2021
Two Labs, an industry-leading pharma services company and a subsidiary of Envision Pharma Group, announced today the acquisition of Riparian, a pharma consulting and SaaS company that assists manufacturers with pricing regulations, reporting, strategies, and program operations.
The acquisition expands Two Labs' pharma service offerings, allowing the company to offer greater insights into the financials associated with drug launch and management, better positioning manufacturers for long-term success. In addition, Riparian's in-depth knowledge of government pricing regulations and program operations, combined with their consulting, business process outsourcing, and software capabilities, enables clients to understand the financials of their drug better, ensuring that the prices reported to the government are in accordance with the current government statutes and regulations.
Riparian and Two Labs will collaborate to accelerate parent company Envision Pharma Group's plans for expansion in the growing biotech pharma sector in the United States. In November 2020, Envision acquired Two Labs.
Riparian will continue to operate from its current headquarters in Henderson, Nevada, with offices in Pasadena, California, and Johnson City, Tennessee. In addition, David Chan and Cynthia Hwang, co-founders, will continue with the company.
About Two Labs
Two Labs is a leading pharmaceutical services company that offers pharmaceutical manufacturers a range of market access, market intelligence, and commercialization services. Two Labs has managed over 200 new product launches and over 290 in-market projects from pre-launch through loss of exclusivity since its start in 2003.
About Envision Pharma Group
Envision Pharma Group, founded in 2001, is a global, innovative technology and scientific communications company that serves pharmaceutical, biotechnology, and medical device companies. Envision is a leading provider of evidence-based communication services and industry-leading technology solutions (iEnvision) with applications in various areas of medical affairs and related functional responsibility. Envision Pharma Group serves over 90 companies, including all top 20 pharmaceutical companies, with services and technology solutions.
Riparian is a pharma Consulting, Outsourcing, and SaaS company based in Henderson, Nevada, assisting manufacturers in navigating government pricing regulations, reporting, strategies, and program operations. Riparian is a rapidly growing, innovative company supported by a team of industry experts.
Farxiga | January 07, 2021
Pushing for another endorsement for SGLT2 prescription Farxiga in persistent kidney illness (CKD), AstraZeneca a year ago posted amazing information in its critical preliminary. Presently, the FDA has acknowledged its CKD application and granted a need survey, setting up a choice for the subsequent quarter—and putting Farxiga significantly farther in front of its future adversaries.
In that preliminary, named Dapa-CKD, AZ's Farxiga in addition to standard of care cut the joined danger of deteriorating kidney capacity or demise brought about via cardiovascular or kidney issues by 39% over fake treatment in certain CKD patients. Furthermore, the medication cut the danger of death from any reason by 31%.
Initially endorsed to control glucose, Farxiga a year ago scored a class-first FDA gesture to lessen the danger of major cardiovascular occasions in patients with cardiovascular breakdown—regardless of whether they have diabetes. Presently, AstraZeneca is planning to change the therapy worldview in persistent kidney sickness. Johnson and Johnson's Invokana conveys a FDA endorsement in diabetic kidney infection, however Farxiga is gunning for a gesture in ongoing kidney sickness with or without type 2 diabetes.
At the point when AZ introduced its definite stage 3 Dapa-CKD results back in August, an executive said the information "truly can possibly modify" clinical course readings. Before that, the organization halted its preliminary early last March after break information "demonstrated Farxiga's advantages sooner than initially envisioned."
The FDA's Wednesday move "presents to us a bit nearer to conveying this new therapy choice for the large numbers of patients living with ongoing kidney illness in the U.S.," AZ's chief VP of biopharma R&D, Mene Pangalos, said in an assertion. "Farxiga can possibly be a really groundbreaking medication across an expansiveness of illnesses, including type 2 diabetes, cardiovascular breakdown with diminished discharge division and, whenever endorsed, constant kidney infection."